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Fecal Transplant Benefits in Primary C Difficile Infection Similar to Vancomycin
, with efficacy that is comparable to the standard treatment of vancomycin, and in some measures, showing even stronger efficacy, new research showed.
“FMT, prepared and administered according to international guidelines, is an effective and safe treatment option for C difficile infections, which should be considered for all patients with the infection,” first author Frederik Emil Juul, MD, PhD, of the Clinical Effectiveness Research Group, University of Oslo, in Oslo, Norway, told GI & Hepatology News.
FMT even showed a numerical superiority to vancomycin, which, though not statistically significant, “indicates that FMT has the potential to change the current practice of antibiotic therapy and may establish FMT as a first-line treatment for primary CDI,” the authors further asserted in the study, published recently in the Annals of Internal Medicine.
In the treatment of antibiotic-associated colitis due to CDI, vancomycin or fidaxomicin are the standard therapies, yet up to 20% of patients experience one or more symptom recurrences following successful initial antibiotic treatment, prompting the need for continued antibiotic regimens, resulting in increased costs and potential adverse events, while contributing to antibiotic resistance.
FMT, designed to restore a normal functional colonic microenvironment with the transfer of a healthy person’s stool, though still somewhat controversial, has gained acceptance and favor in recent years in the treatment of recurrent CDI, however, research has been lacking on its efficacy in the treatment of primary CDI.
With a previous proof-of-concept trial and observational study showing promising results in primary CDI, Juul and colleagues conducted the current randomized, open-label noninferiority trial.
For the multi-center study, 100 adult patients with CDI, defined as C diff toxin in stool and at least three loose stools daily, and no previous CDI within 1 year prior to enrollment, were randomized at 20 hospitals in Norway to receive either FMT, administered as an enema, without antibiotic pretreatment, or oral vancomycin at a dose of 125 mg, four times daily for 10 days.
The patients had a median age of about 70 years; more than 40% of patients had a Charlson Comorbidity Index score of ≥ 4, indicating severe comorbidity, and a third had severe CDI.
With the trial showing favorable results, a data and safety monitoring board recommended stopping the trial for efficacy and noninferiority after about half of the planned enrollment was reached.
The primary endpoint of a clinical cure, defined as firm stools or less than three bowel movements daily and no disease recurrence within 60 days without additional treatment, was observed in 34 of 51 patients who received FMT (66.7%) compared with 30 of 49 of those receiving vancomycin (61.2%; difference, 5.4 percentage points; P for noninferiority < .001).
The results contradict the theory that response to FMT is 25 percentage points lower than response to vancomycin, the authors noted.
The proportion of patients with clinical cure at day 14 was 70.6% in the FMT group and 77.6% in the vancomycin group, and among those patients, two (5.6%) in the FMT group had disease recurrence compared with eight (21.1%) in the vancomycin group between days 15 and 60.
In the FMT group, 11 patients received additional treatment compared with four in the vancomycin group, predominantly oral vancomycin in both groups.
Despite the high rates of severe comorbidity among the patients at baseline, a subgroup analyses showed no significant differences in treatment effects based on factors including sex, age group, Charlson Comorbidity Index score, or CDI severity.
Importantly, there were also no significant differences in adverse events between the groups.
“Our results indicate that it is reasonable to treat patients with primary CDI with FMT and provide antibiotics only to patients with ongoing symptoms or recurrence after FMT,” the authors concluded.
FMT Faces Challenges in the US
FMT specifically consists of direct instillation of fecal matter to the upper gastrointestinal tract, via capsules or duodenal infusion, or the lower gastrointestinal tract via colonoscopy or enema.
While an AGA guideline issued in 2024 endorsed FMT for the prevention of recurrent, refractory, or fulminant CDI in select adults not responding to standard antibiotics, the association underscored important caveats, including a low quality of evidence, and concluded that FMT could not yet be recommended for other gastrointestinal conditions.
The treatment meanwhile has faced an uphill battle in the US. The provision of screened FMT inocula through the nonprofit OpenBiome, previously the country’s largest stool bank, was recently suspended amid FDA policy changes.
And while other commercial-grade biotherapeutic products Rebyota and Vowst, have received FDA approval, cost and insurance coverage can be significant barriers, said Elizabeth Hohmann, MD, of the Infectious Disease Division at Massachusetts General Hospital, Boston, in an editorial published with the study.
“Currently approved options are expensive and are not available to many who might benefit for various reasons, primarily cost,” she said.
Acceptance Higher in Europe
In Europe, and particularly Norway, acceptance of FMT for CDI and other indications has been more favorable, and while regulation of the treatment has varied among European countries, a new regulation to be implemented by the European Union in 2027 will improve standardization of the production, handling, storage, and other factors of FMT, Juul told GI & Hepatology News.
“I believe the new regulations will make the treatment more available to patients, and a standardization of the FMT production will make future trials more comparable and useful across countries,” he said.
Juul said he further expects that “our results will lower the threshold for choosing FMT as treatment in primary infections. I know that Denmark also gives FMT to patients with primary CDI.”
Quality of Life
Hohmann, who has treated many patients with recurrent CDI with FMT, noted that a key factor that should be underscored is how much better patients can feel after the treatment.
“Although there are no quality of life surveys in [the current study], had they been done, I suspect quality of life might have been higher in the FMT group; in my experience, people feel better after microbiome restoration.”
She added that her patients “report feeling much better, and that’s why I keep doing it,” she said. “I’ve had an 80-year-old patient tell me he’s going back to snow shoveling; another saying she can return to yoga classes.”
“When you have had bad gut microbiome dysbiosis that becomes normal, you feel a lot better,” Hohmann said.
In the treatment of primary CDI, however, Hohmann said the prospects, at least in the US, are likely slim.
“I do not believe that we in the United States will see FMT as a primary treatment of C difficile infection anytime soon,” she wrote in the editorial.
Nevertheless, Hohmann asserted that “FMT should remain available, with appropriate sources of carefully screened inocula for care and for further research into the many illnesses and therapies that are influenced by the health of the gut microbiome.”
This study received funding from the South-East Norway Health Trust. Hohmann had no disclosures to report.
A version of this article appeared on Medscape.com.
, with efficacy that is comparable to the standard treatment of vancomycin, and in some measures, showing even stronger efficacy, new research showed.
“FMT, prepared and administered according to international guidelines, is an effective and safe treatment option for C difficile infections, which should be considered for all patients with the infection,” first author Frederik Emil Juul, MD, PhD, of the Clinical Effectiveness Research Group, University of Oslo, in Oslo, Norway, told GI & Hepatology News.
FMT even showed a numerical superiority to vancomycin, which, though not statistically significant, “indicates that FMT has the potential to change the current practice of antibiotic therapy and may establish FMT as a first-line treatment for primary CDI,” the authors further asserted in the study, published recently in the Annals of Internal Medicine.
In the treatment of antibiotic-associated colitis due to CDI, vancomycin or fidaxomicin are the standard therapies, yet up to 20% of patients experience one or more symptom recurrences following successful initial antibiotic treatment, prompting the need for continued antibiotic regimens, resulting in increased costs and potential adverse events, while contributing to antibiotic resistance.
FMT, designed to restore a normal functional colonic microenvironment with the transfer of a healthy person’s stool, though still somewhat controversial, has gained acceptance and favor in recent years in the treatment of recurrent CDI, however, research has been lacking on its efficacy in the treatment of primary CDI.
With a previous proof-of-concept trial and observational study showing promising results in primary CDI, Juul and colleagues conducted the current randomized, open-label noninferiority trial.
For the multi-center study, 100 adult patients with CDI, defined as C diff toxin in stool and at least three loose stools daily, and no previous CDI within 1 year prior to enrollment, were randomized at 20 hospitals in Norway to receive either FMT, administered as an enema, without antibiotic pretreatment, or oral vancomycin at a dose of 125 mg, four times daily for 10 days.
The patients had a median age of about 70 years; more than 40% of patients had a Charlson Comorbidity Index score of ≥ 4, indicating severe comorbidity, and a third had severe CDI.
With the trial showing favorable results, a data and safety monitoring board recommended stopping the trial for efficacy and noninferiority after about half of the planned enrollment was reached.
The primary endpoint of a clinical cure, defined as firm stools or less than three bowel movements daily and no disease recurrence within 60 days without additional treatment, was observed in 34 of 51 patients who received FMT (66.7%) compared with 30 of 49 of those receiving vancomycin (61.2%; difference, 5.4 percentage points; P for noninferiority < .001).
The results contradict the theory that response to FMT is 25 percentage points lower than response to vancomycin, the authors noted.
The proportion of patients with clinical cure at day 14 was 70.6% in the FMT group and 77.6% in the vancomycin group, and among those patients, two (5.6%) in the FMT group had disease recurrence compared with eight (21.1%) in the vancomycin group between days 15 and 60.
In the FMT group, 11 patients received additional treatment compared with four in the vancomycin group, predominantly oral vancomycin in both groups.
Despite the high rates of severe comorbidity among the patients at baseline, a subgroup analyses showed no significant differences in treatment effects based on factors including sex, age group, Charlson Comorbidity Index score, or CDI severity.
Importantly, there were also no significant differences in adverse events between the groups.
“Our results indicate that it is reasonable to treat patients with primary CDI with FMT and provide antibiotics only to patients with ongoing symptoms or recurrence after FMT,” the authors concluded.
FMT Faces Challenges in the US
FMT specifically consists of direct instillation of fecal matter to the upper gastrointestinal tract, via capsules or duodenal infusion, or the lower gastrointestinal tract via colonoscopy or enema.
While an AGA guideline issued in 2024 endorsed FMT for the prevention of recurrent, refractory, or fulminant CDI in select adults not responding to standard antibiotics, the association underscored important caveats, including a low quality of evidence, and concluded that FMT could not yet be recommended for other gastrointestinal conditions.
The treatment meanwhile has faced an uphill battle in the US. The provision of screened FMT inocula through the nonprofit OpenBiome, previously the country’s largest stool bank, was recently suspended amid FDA policy changes.
And while other commercial-grade biotherapeutic products Rebyota and Vowst, have received FDA approval, cost and insurance coverage can be significant barriers, said Elizabeth Hohmann, MD, of the Infectious Disease Division at Massachusetts General Hospital, Boston, in an editorial published with the study.
“Currently approved options are expensive and are not available to many who might benefit for various reasons, primarily cost,” she said.
Acceptance Higher in Europe
In Europe, and particularly Norway, acceptance of FMT for CDI and other indications has been more favorable, and while regulation of the treatment has varied among European countries, a new regulation to be implemented by the European Union in 2027 will improve standardization of the production, handling, storage, and other factors of FMT, Juul told GI & Hepatology News.
“I believe the new regulations will make the treatment more available to patients, and a standardization of the FMT production will make future trials more comparable and useful across countries,” he said.
Juul said he further expects that “our results will lower the threshold for choosing FMT as treatment in primary infections. I know that Denmark also gives FMT to patients with primary CDI.”
Quality of Life
Hohmann, who has treated many patients with recurrent CDI with FMT, noted that a key factor that should be underscored is how much better patients can feel after the treatment.
“Although there are no quality of life surveys in [the current study], had they been done, I suspect quality of life might have been higher in the FMT group; in my experience, people feel better after microbiome restoration.”
She added that her patients “report feeling much better, and that’s why I keep doing it,” she said. “I’ve had an 80-year-old patient tell me he’s going back to snow shoveling; another saying she can return to yoga classes.”
“When you have had bad gut microbiome dysbiosis that becomes normal, you feel a lot better,” Hohmann said.
In the treatment of primary CDI, however, Hohmann said the prospects, at least in the US, are likely slim.
“I do not believe that we in the United States will see FMT as a primary treatment of C difficile infection anytime soon,” she wrote in the editorial.
Nevertheless, Hohmann asserted that “FMT should remain available, with appropriate sources of carefully screened inocula for care and for further research into the many illnesses and therapies that are influenced by the health of the gut microbiome.”
This study received funding from the South-East Norway Health Trust. Hohmann had no disclosures to report.
A version of this article appeared on Medscape.com.
, with efficacy that is comparable to the standard treatment of vancomycin, and in some measures, showing even stronger efficacy, new research showed.
“FMT, prepared and administered according to international guidelines, is an effective and safe treatment option for C difficile infections, which should be considered for all patients with the infection,” first author Frederik Emil Juul, MD, PhD, of the Clinical Effectiveness Research Group, University of Oslo, in Oslo, Norway, told GI & Hepatology News.
FMT even showed a numerical superiority to vancomycin, which, though not statistically significant, “indicates that FMT has the potential to change the current practice of antibiotic therapy and may establish FMT as a first-line treatment for primary CDI,” the authors further asserted in the study, published recently in the Annals of Internal Medicine.
In the treatment of antibiotic-associated colitis due to CDI, vancomycin or fidaxomicin are the standard therapies, yet up to 20% of patients experience one or more symptom recurrences following successful initial antibiotic treatment, prompting the need for continued antibiotic regimens, resulting in increased costs and potential adverse events, while contributing to antibiotic resistance.
FMT, designed to restore a normal functional colonic microenvironment with the transfer of a healthy person’s stool, though still somewhat controversial, has gained acceptance and favor in recent years in the treatment of recurrent CDI, however, research has been lacking on its efficacy in the treatment of primary CDI.
With a previous proof-of-concept trial and observational study showing promising results in primary CDI, Juul and colleagues conducted the current randomized, open-label noninferiority trial.
For the multi-center study, 100 adult patients with CDI, defined as C diff toxin in stool and at least three loose stools daily, and no previous CDI within 1 year prior to enrollment, were randomized at 20 hospitals in Norway to receive either FMT, administered as an enema, without antibiotic pretreatment, or oral vancomycin at a dose of 125 mg, four times daily for 10 days.
The patients had a median age of about 70 years; more than 40% of patients had a Charlson Comorbidity Index score of ≥ 4, indicating severe comorbidity, and a third had severe CDI.
With the trial showing favorable results, a data and safety monitoring board recommended stopping the trial for efficacy and noninferiority after about half of the planned enrollment was reached.
The primary endpoint of a clinical cure, defined as firm stools or less than three bowel movements daily and no disease recurrence within 60 days without additional treatment, was observed in 34 of 51 patients who received FMT (66.7%) compared with 30 of 49 of those receiving vancomycin (61.2%; difference, 5.4 percentage points; P for noninferiority < .001).
The results contradict the theory that response to FMT is 25 percentage points lower than response to vancomycin, the authors noted.
The proportion of patients with clinical cure at day 14 was 70.6% in the FMT group and 77.6% in the vancomycin group, and among those patients, two (5.6%) in the FMT group had disease recurrence compared with eight (21.1%) in the vancomycin group between days 15 and 60.
In the FMT group, 11 patients received additional treatment compared with four in the vancomycin group, predominantly oral vancomycin in both groups.
Despite the high rates of severe comorbidity among the patients at baseline, a subgroup analyses showed no significant differences in treatment effects based on factors including sex, age group, Charlson Comorbidity Index score, or CDI severity.
Importantly, there were also no significant differences in adverse events between the groups.
“Our results indicate that it is reasonable to treat patients with primary CDI with FMT and provide antibiotics only to patients with ongoing symptoms or recurrence after FMT,” the authors concluded.
FMT Faces Challenges in the US
FMT specifically consists of direct instillation of fecal matter to the upper gastrointestinal tract, via capsules or duodenal infusion, or the lower gastrointestinal tract via colonoscopy or enema.
While an AGA guideline issued in 2024 endorsed FMT for the prevention of recurrent, refractory, or fulminant CDI in select adults not responding to standard antibiotics, the association underscored important caveats, including a low quality of evidence, and concluded that FMT could not yet be recommended for other gastrointestinal conditions.
The treatment meanwhile has faced an uphill battle in the US. The provision of screened FMT inocula through the nonprofit OpenBiome, previously the country’s largest stool bank, was recently suspended amid FDA policy changes.
And while other commercial-grade biotherapeutic products Rebyota and Vowst, have received FDA approval, cost and insurance coverage can be significant barriers, said Elizabeth Hohmann, MD, of the Infectious Disease Division at Massachusetts General Hospital, Boston, in an editorial published with the study.
“Currently approved options are expensive and are not available to many who might benefit for various reasons, primarily cost,” she said.
Acceptance Higher in Europe
In Europe, and particularly Norway, acceptance of FMT for CDI and other indications has been more favorable, and while regulation of the treatment has varied among European countries, a new regulation to be implemented by the European Union in 2027 will improve standardization of the production, handling, storage, and other factors of FMT, Juul told GI & Hepatology News.
“I believe the new regulations will make the treatment more available to patients, and a standardization of the FMT production will make future trials more comparable and useful across countries,” he said.
Juul said he further expects that “our results will lower the threshold for choosing FMT as treatment in primary infections. I know that Denmark also gives FMT to patients with primary CDI.”
Quality of Life
Hohmann, who has treated many patients with recurrent CDI with FMT, noted that a key factor that should be underscored is how much better patients can feel after the treatment.
“Although there are no quality of life surveys in [the current study], had they been done, I suspect quality of life might have been higher in the FMT group; in my experience, people feel better after microbiome restoration.”
She added that her patients “report feeling much better, and that’s why I keep doing it,” she said. “I’ve had an 80-year-old patient tell me he’s going back to snow shoveling; another saying she can return to yoga classes.”
“When you have had bad gut microbiome dysbiosis that becomes normal, you feel a lot better,” Hohmann said.
In the treatment of primary CDI, however, Hohmann said the prospects, at least in the US, are likely slim.
“I do not believe that we in the United States will see FMT as a primary treatment of C difficile infection anytime soon,” she wrote in the editorial.
Nevertheless, Hohmann asserted that “FMT should remain available, with appropriate sources of carefully screened inocula for care and for further research into the many illnesses and therapies that are influenced by the health of the gut microbiome.”
This study received funding from the South-East Norway Health Trust. Hohmann had no disclosures to report.
A version of this article appeared on Medscape.com.
Withdrawing Anti-TNF in IBD Remission: New Data
In the Spanish EXIT study, anti-TNF withdrawal in selected patients with IBD in clinical, endoscopic, and radiological remission had no impact on sustained clinical remission at 1 year, although objective markers of activity were higher in patients who stopped treatment.
The discontinuation of anti-TNF treatment “could be considered as an option” for a selected group of patients, said the authors led by Javier Gisbert, MD, PhD, with Autonomous University of Madrid.
However, the higher proportion of patients with elevated fecal calprotectin and significant endoscopic lesions at the end of follow-up “calls for caution and should be considered when discontinuing treatment in patients,” Gisbert and colleagues concluded.
The EXIT study results were published in the journal Gut (2025 Feb. doi: 10.1136/gutjnl-2024-333385).
Risky Business?
Anti-TNF drugs have reshaped IBD treatment but bring infection risks and costs, prompting interest in planned withdrawal after stable remission.
Yet prior evidence has been mixed. A meta-analysis of 27 studies suggested higher relapse after stopping anti-TNF therapy. However, the results were heterogeneous and most of the studies were retrospective, with a low number of patients and without a control group to compare with.
Clinical trials that have assessed the risk for relapse after discontinuation of anti-TNF therapy generally favored maintenance but had notable limitations.
The EXIT trial was conducted at 33 IBD units across Spain. A total of 140 patients in steroid-free clinical remission for ≥ 6 months on standard-dose infliximab or adalimumab were randomized (1:1) to either continue anti-TNF or switch to placebo matched to the drug they had been taking. All patients continued on immunomodulator therapy.
At 1 year, the proportion of patients with sustained clinical remission (primary outcome) was similar between patients who continued anti-TNF therapy and peers who stopped the medication (76% and 84%, respectively).
However, the proportion of patients with significant endoscopic lesions at the end of follow-up was higher in those who withdrew anti-TNF therapy (19% vs 8.5%; P = .01). Elevated fecal calprotectin (> 250 µg/g) was more common after withdrawal (33% vs 13%; P = .01).
Fecal calprotectin > 250 µg/g at baseline predicted lower odds of sustained remission and higher risk for losing remission — and was the only factor associated with lower likelihood of sustained remission.
Common Clinical Question
“When a patient starts an advanced biologic therapy, they often ask — will I be able to stop it?” Jean-Frederic Colombel, MD, director of the Inflammatory Bowel Disease Clinical Center at the Icahn School of Medicine at Mount Sinai, New York City, who wasn’t involved in the study, told GI & Hepatology News.
Generally speaking, Colombel said he tells patients, “If the drug is working well and you are in deep remission, they should try to avoid stopping because there is a risk of relapse. And with relapse, we never know if the drug will work again and maybe we’ll have to switch to another medication.”
“It’s an individualized discussion and decision and patients who do opt to stop [anti-TNF therapy] need to be monitored closely,” Colombel said.
Colombel cautioned that the study had a relatively short 1-year follow-up and those that stopped anti-TNF therapy had evidence of recurrent inflammation.
“Even though it didn’t translate yet to clinical relapse, there were more patients with subclinical active disease in the group that stopped as compared to the group that continued,” Colombel said.
He also noted that in the SPARE trial of patients with Crohn’s disease in clinical remission, patients who stopped infliximab had a higher risk for relapse compared with patients who stopped azathioprine and those who continued the combination therapy.
The EXIT study was supported by grants from Instituto de Salud Carlos III, Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa and AbbVie. Gisbert reported serving as speaker, consultant, and advisory member for or receiving research funding from MSD, AbbVie, Pfizer, Kern Pharma, Biogen, Mylan, Takeda, Janssen, Roche, Sandoz, Celgene/Bristol Myers, Gilead/Galapagos, Lilly, Ferring, Faes Farma, Shire Pharmaceuticals, Dr. Falk Pharma, Tillotts Pharma, Chiesi, Casen Fleet, Gebro Pharma, Otsuka Pharmaceutical, Norgine and Vifor Pharma. Colombel had no relevant disclosures.
A version of this article appeared on Medscape.com.
In the Spanish EXIT study, anti-TNF withdrawal in selected patients with IBD in clinical, endoscopic, and radiological remission had no impact on sustained clinical remission at 1 year, although objective markers of activity were higher in patients who stopped treatment.
The discontinuation of anti-TNF treatment “could be considered as an option” for a selected group of patients, said the authors led by Javier Gisbert, MD, PhD, with Autonomous University of Madrid.
However, the higher proportion of patients with elevated fecal calprotectin and significant endoscopic lesions at the end of follow-up “calls for caution and should be considered when discontinuing treatment in patients,” Gisbert and colleagues concluded.
The EXIT study results were published in the journal Gut (2025 Feb. doi: 10.1136/gutjnl-2024-333385).
Risky Business?
Anti-TNF drugs have reshaped IBD treatment but bring infection risks and costs, prompting interest in planned withdrawal after stable remission.
Yet prior evidence has been mixed. A meta-analysis of 27 studies suggested higher relapse after stopping anti-TNF therapy. However, the results were heterogeneous and most of the studies were retrospective, with a low number of patients and without a control group to compare with.
Clinical trials that have assessed the risk for relapse after discontinuation of anti-TNF therapy generally favored maintenance but had notable limitations.
The EXIT trial was conducted at 33 IBD units across Spain. A total of 140 patients in steroid-free clinical remission for ≥ 6 months on standard-dose infliximab or adalimumab were randomized (1:1) to either continue anti-TNF or switch to placebo matched to the drug they had been taking. All patients continued on immunomodulator therapy.
At 1 year, the proportion of patients with sustained clinical remission (primary outcome) was similar between patients who continued anti-TNF therapy and peers who stopped the medication (76% and 84%, respectively).
However, the proportion of patients with significant endoscopic lesions at the end of follow-up was higher in those who withdrew anti-TNF therapy (19% vs 8.5%; P = .01). Elevated fecal calprotectin (> 250 µg/g) was more common after withdrawal (33% vs 13%; P = .01).
Fecal calprotectin > 250 µg/g at baseline predicted lower odds of sustained remission and higher risk for losing remission — and was the only factor associated with lower likelihood of sustained remission.
Common Clinical Question
“When a patient starts an advanced biologic therapy, they often ask — will I be able to stop it?” Jean-Frederic Colombel, MD, director of the Inflammatory Bowel Disease Clinical Center at the Icahn School of Medicine at Mount Sinai, New York City, who wasn’t involved in the study, told GI & Hepatology News.
Generally speaking, Colombel said he tells patients, “If the drug is working well and you are in deep remission, they should try to avoid stopping because there is a risk of relapse. And with relapse, we never know if the drug will work again and maybe we’ll have to switch to another medication.”
“It’s an individualized discussion and decision and patients who do opt to stop [anti-TNF therapy] need to be monitored closely,” Colombel said.
Colombel cautioned that the study had a relatively short 1-year follow-up and those that stopped anti-TNF therapy had evidence of recurrent inflammation.
“Even though it didn’t translate yet to clinical relapse, there were more patients with subclinical active disease in the group that stopped as compared to the group that continued,” Colombel said.
He also noted that in the SPARE trial of patients with Crohn’s disease in clinical remission, patients who stopped infliximab had a higher risk for relapse compared with patients who stopped azathioprine and those who continued the combination therapy.
The EXIT study was supported by grants from Instituto de Salud Carlos III, Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa and AbbVie. Gisbert reported serving as speaker, consultant, and advisory member for or receiving research funding from MSD, AbbVie, Pfizer, Kern Pharma, Biogen, Mylan, Takeda, Janssen, Roche, Sandoz, Celgene/Bristol Myers, Gilead/Galapagos, Lilly, Ferring, Faes Farma, Shire Pharmaceuticals, Dr. Falk Pharma, Tillotts Pharma, Chiesi, Casen Fleet, Gebro Pharma, Otsuka Pharmaceutical, Norgine and Vifor Pharma. Colombel had no relevant disclosures.
A version of this article appeared on Medscape.com.
In the Spanish EXIT study, anti-TNF withdrawal in selected patients with IBD in clinical, endoscopic, and radiological remission had no impact on sustained clinical remission at 1 year, although objective markers of activity were higher in patients who stopped treatment.
The discontinuation of anti-TNF treatment “could be considered as an option” for a selected group of patients, said the authors led by Javier Gisbert, MD, PhD, with Autonomous University of Madrid.
However, the higher proportion of patients with elevated fecal calprotectin and significant endoscopic lesions at the end of follow-up “calls for caution and should be considered when discontinuing treatment in patients,” Gisbert and colleagues concluded.
The EXIT study results were published in the journal Gut (2025 Feb. doi: 10.1136/gutjnl-2024-333385).
Risky Business?
Anti-TNF drugs have reshaped IBD treatment but bring infection risks and costs, prompting interest in planned withdrawal after stable remission.
Yet prior evidence has been mixed. A meta-analysis of 27 studies suggested higher relapse after stopping anti-TNF therapy. However, the results were heterogeneous and most of the studies were retrospective, with a low number of patients and without a control group to compare with.
Clinical trials that have assessed the risk for relapse after discontinuation of anti-TNF therapy generally favored maintenance but had notable limitations.
The EXIT trial was conducted at 33 IBD units across Spain. A total of 140 patients in steroid-free clinical remission for ≥ 6 months on standard-dose infliximab or adalimumab were randomized (1:1) to either continue anti-TNF or switch to placebo matched to the drug they had been taking. All patients continued on immunomodulator therapy.
At 1 year, the proportion of patients with sustained clinical remission (primary outcome) was similar between patients who continued anti-TNF therapy and peers who stopped the medication (76% and 84%, respectively).
However, the proportion of patients with significant endoscopic lesions at the end of follow-up was higher in those who withdrew anti-TNF therapy (19% vs 8.5%; P = .01). Elevated fecal calprotectin (> 250 µg/g) was more common after withdrawal (33% vs 13%; P = .01).
Fecal calprotectin > 250 µg/g at baseline predicted lower odds of sustained remission and higher risk for losing remission — and was the only factor associated with lower likelihood of sustained remission.
Common Clinical Question
“When a patient starts an advanced biologic therapy, they often ask — will I be able to stop it?” Jean-Frederic Colombel, MD, director of the Inflammatory Bowel Disease Clinical Center at the Icahn School of Medicine at Mount Sinai, New York City, who wasn’t involved in the study, told GI & Hepatology News.
Generally speaking, Colombel said he tells patients, “If the drug is working well and you are in deep remission, they should try to avoid stopping because there is a risk of relapse. And with relapse, we never know if the drug will work again and maybe we’ll have to switch to another medication.”
“It’s an individualized discussion and decision and patients who do opt to stop [anti-TNF therapy] need to be monitored closely,” Colombel said.
Colombel cautioned that the study had a relatively short 1-year follow-up and those that stopped anti-TNF therapy had evidence of recurrent inflammation.
“Even though it didn’t translate yet to clinical relapse, there were more patients with subclinical active disease in the group that stopped as compared to the group that continued,” Colombel said.
He also noted that in the SPARE trial of patients with Crohn’s disease in clinical remission, patients who stopped infliximab had a higher risk for relapse compared with patients who stopped azathioprine and those who continued the combination therapy.
The EXIT study was supported by grants from Instituto de Salud Carlos III, Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa and AbbVie. Gisbert reported serving as speaker, consultant, and advisory member for or receiving research funding from MSD, AbbVie, Pfizer, Kern Pharma, Biogen, Mylan, Takeda, Janssen, Roche, Sandoz, Celgene/Bristol Myers, Gilead/Galapagos, Lilly, Ferring, Faes Farma, Shire Pharmaceuticals, Dr. Falk Pharma, Tillotts Pharma, Chiesi, Casen Fleet, Gebro Pharma, Otsuka Pharmaceutical, Norgine and Vifor Pharma. Colombel had no relevant disclosures.
A version of this article appeared on Medscape.com.
Oral Microbes Tied to Pancreatic Cancer Risk
Could oral microbiome profiling help spot people at risk for pancreatic cancer?
It may be possible, according to a recent analysis published in JAMA Oncology.
Researchers found that , which could be a step toward earlier detection of the deadly malignancy.
“We identified 27 individual bacterial and fungal species significantly associated with pancreatic cancer development,” said Jiyoung Ahn, PhD, of NYU Grossman School of Medicine in New York City.
“If validated, oral microbiome profiling could serve as a noninvasive biomarker to identify individuals at elevated risk who might benefit from enhanced surveillance,” Ahn told GI & Hepatology News by email.
Rates of pancreatic cancer are on the rise. But detecting the disease before it becomes unresectable has remained an elusive goal, and the US Preventive Services Task Force discourages screening of asymptomatic adults.
For their study, Ahn and her colleagues analyzed data from 122,000 participants who provided oral wash samples as part of two cohort studies conducted in the US. The researchers used whole-genome shotgun sequencing and internal transcribed spacer sequencing to identity the bacterial and fungal species in the samples, respectively.
Over a median follow-up of nearly 9 years, 445 people developed pancreatic cancer and were matched with 445 who did not. Three oral bacterial periodontal pathogens — Porphyromonas gingivalis (odds ratio [OR], 1.27), Eubacterium nodatum (OR, 1.42), and Parvimonas micra (OR, 1.36) — as well as the fungal genus Candida were all linked to significantly increased odds of developing pancreatic cancer.
In a bacteriome-wide scan, the researchers pinpointed another 20 oral bacteria associated with pancreatic cancer — eight with a decreased risk and 13 with an increased risk for the disease.
The researchers also calculated a microbial risk score, which was the weighted sum of the relative abundance of bacterial and fungal species. In a meta-analysis of data from the two cohorts, the microbial risk score derived from 23 bacterial species and four fungal species, including various Candida species, was associated with pancreatic cancer (multivariate OR per 1-SD increase in the score, 3.44; 95% CI, 2.63-4.51).
“The oral microbiota holds promise as a biomarker to identify individuals at high risk of pancreatic cancer, potentially enabling personalized pancreatic cancer prevention,” Ahn and her colleagues concluded.
But Gil Welch, MD, of Brigham and Women’s Hospital in Boston, who has written about screening for decades, isn’t so sure.
Given the “impressive volume of information” included in the analysis, “it is not surprising that the investigators are able to create a microbial risk score (based on 27 species of bacteria and fungi) that is highly related to pancreatic cancer,” Welch said. “The authors are careful to emphasize these are associations, not causal relationships.”
But even if the relationship were causal, finding more people with the malignancy can also have downsides, said Welch.
In a study out last year, Welch and colleagues found that while the incidence of pancreatic cancer among young Americans has been rising, mortality rates in this demographic haven’t budged, suggesting a potential for overdiagnosis.
“Screening for pancreatic cancer has never been shown to reduce pancreatic cancer mortality,” Welch told GI & Hepatology News. “Why screen large swaths of the population simply to enumerate ‘risk factors’ for an unproven benefit that, at best, could help only a few? Meanwhile, the burdens for everyone else are real: the mental and financial strains of ‘high risk’ labels, false alarms, and endless follow-ups. It’s a recipe to make us all worried sick — and poorer.”
Ahn reported having no disclosures. Welch reported receiving royalties from three books including “Should I be tested for cancer?”
A version of this article appeared on Medscape.com.
Could oral microbiome profiling help spot people at risk for pancreatic cancer?
It may be possible, according to a recent analysis published in JAMA Oncology.
Researchers found that , which could be a step toward earlier detection of the deadly malignancy.
“We identified 27 individual bacterial and fungal species significantly associated with pancreatic cancer development,” said Jiyoung Ahn, PhD, of NYU Grossman School of Medicine in New York City.
“If validated, oral microbiome profiling could serve as a noninvasive biomarker to identify individuals at elevated risk who might benefit from enhanced surveillance,” Ahn told GI & Hepatology News by email.
Rates of pancreatic cancer are on the rise. But detecting the disease before it becomes unresectable has remained an elusive goal, and the US Preventive Services Task Force discourages screening of asymptomatic adults.
For their study, Ahn and her colleagues analyzed data from 122,000 participants who provided oral wash samples as part of two cohort studies conducted in the US. The researchers used whole-genome shotgun sequencing and internal transcribed spacer sequencing to identity the bacterial and fungal species in the samples, respectively.
Over a median follow-up of nearly 9 years, 445 people developed pancreatic cancer and were matched with 445 who did not. Three oral bacterial periodontal pathogens — Porphyromonas gingivalis (odds ratio [OR], 1.27), Eubacterium nodatum (OR, 1.42), and Parvimonas micra (OR, 1.36) — as well as the fungal genus Candida were all linked to significantly increased odds of developing pancreatic cancer.
In a bacteriome-wide scan, the researchers pinpointed another 20 oral bacteria associated with pancreatic cancer — eight with a decreased risk and 13 with an increased risk for the disease.
The researchers also calculated a microbial risk score, which was the weighted sum of the relative abundance of bacterial and fungal species. In a meta-analysis of data from the two cohorts, the microbial risk score derived from 23 bacterial species and four fungal species, including various Candida species, was associated with pancreatic cancer (multivariate OR per 1-SD increase in the score, 3.44; 95% CI, 2.63-4.51).
“The oral microbiota holds promise as a biomarker to identify individuals at high risk of pancreatic cancer, potentially enabling personalized pancreatic cancer prevention,” Ahn and her colleagues concluded.
But Gil Welch, MD, of Brigham and Women’s Hospital in Boston, who has written about screening for decades, isn’t so sure.
Given the “impressive volume of information” included in the analysis, “it is not surprising that the investigators are able to create a microbial risk score (based on 27 species of bacteria and fungi) that is highly related to pancreatic cancer,” Welch said. “The authors are careful to emphasize these are associations, not causal relationships.”
But even if the relationship were causal, finding more people with the malignancy can also have downsides, said Welch.
In a study out last year, Welch and colleagues found that while the incidence of pancreatic cancer among young Americans has been rising, mortality rates in this demographic haven’t budged, suggesting a potential for overdiagnosis.
“Screening for pancreatic cancer has never been shown to reduce pancreatic cancer mortality,” Welch told GI & Hepatology News. “Why screen large swaths of the population simply to enumerate ‘risk factors’ for an unproven benefit that, at best, could help only a few? Meanwhile, the burdens for everyone else are real: the mental and financial strains of ‘high risk’ labels, false alarms, and endless follow-ups. It’s a recipe to make us all worried sick — and poorer.”
Ahn reported having no disclosures. Welch reported receiving royalties from three books including “Should I be tested for cancer?”
A version of this article appeared on Medscape.com.
Could oral microbiome profiling help spot people at risk for pancreatic cancer?
It may be possible, according to a recent analysis published in JAMA Oncology.
Researchers found that , which could be a step toward earlier detection of the deadly malignancy.
“We identified 27 individual bacterial and fungal species significantly associated with pancreatic cancer development,” said Jiyoung Ahn, PhD, of NYU Grossman School of Medicine in New York City.
“If validated, oral microbiome profiling could serve as a noninvasive biomarker to identify individuals at elevated risk who might benefit from enhanced surveillance,” Ahn told GI & Hepatology News by email.
Rates of pancreatic cancer are on the rise. But detecting the disease before it becomes unresectable has remained an elusive goal, and the US Preventive Services Task Force discourages screening of asymptomatic adults.
For their study, Ahn and her colleagues analyzed data from 122,000 participants who provided oral wash samples as part of two cohort studies conducted in the US. The researchers used whole-genome shotgun sequencing and internal transcribed spacer sequencing to identity the bacterial and fungal species in the samples, respectively.
Over a median follow-up of nearly 9 years, 445 people developed pancreatic cancer and were matched with 445 who did not. Three oral bacterial periodontal pathogens — Porphyromonas gingivalis (odds ratio [OR], 1.27), Eubacterium nodatum (OR, 1.42), and Parvimonas micra (OR, 1.36) — as well as the fungal genus Candida were all linked to significantly increased odds of developing pancreatic cancer.
In a bacteriome-wide scan, the researchers pinpointed another 20 oral bacteria associated with pancreatic cancer — eight with a decreased risk and 13 with an increased risk for the disease.
The researchers also calculated a microbial risk score, which was the weighted sum of the relative abundance of bacterial and fungal species. In a meta-analysis of data from the two cohorts, the microbial risk score derived from 23 bacterial species and four fungal species, including various Candida species, was associated with pancreatic cancer (multivariate OR per 1-SD increase in the score, 3.44; 95% CI, 2.63-4.51).
“The oral microbiota holds promise as a biomarker to identify individuals at high risk of pancreatic cancer, potentially enabling personalized pancreatic cancer prevention,” Ahn and her colleagues concluded.
But Gil Welch, MD, of Brigham and Women’s Hospital in Boston, who has written about screening for decades, isn’t so sure.
Given the “impressive volume of information” included in the analysis, “it is not surprising that the investigators are able to create a microbial risk score (based on 27 species of bacteria and fungi) that is highly related to pancreatic cancer,” Welch said. “The authors are careful to emphasize these are associations, not causal relationships.”
But even if the relationship were causal, finding more people with the malignancy can also have downsides, said Welch.
In a study out last year, Welch and colleagues found that while the incidence of pancreatic cancer among young Americans has been rising, mortality rates in this demographic haven’t budged, suggesting a potential for overdiagnosis.
“Screening for pancreatic cancer has never been shown to reduce pancreatic cancer mortality,” Welch told GI & Hepatology News. “Why screen large swaths of the population simply to enumerate ‘risk factors’ for an unproven benefit that, at best, could help only a few? Meanwhile, the burdens for everyone else are real: the mental and financial strains of ‘high risk’ labels, false alarms, and endless follow-ups. It’s a recipe to make us all worried sick — and poorer.”
Ahn reported having no disclosures. Welch reported receiving royalties from three books including “Should I be tested for cancer?”
A version of this article appeared on Medscape.com.
How Chronic Stress Disrupts the Gut Microbiome
Chronic psychological stress is common. A 2023 survey revealed that about one quarter of US adults reported high stress levels, and three quarters reported that chronic stress affects their daily lives.
Emerging evidence suggests that chronic stress not only exacts a high toll on mental health but also can wreak havoc on all levels of gastrointestinal (GI) functioning, all the way down to the microbiome.
Aasma Shaukat, MD, MPH, AGAF, gastroenterologist with NYU Langone Health and director of GI Outcomes Research, Gastroenterology at NYU Grossman School of Medicine in New York City, said in an interview with GI & Hepatology News.
“This basically means that the normal balance of microorganisms that essentially we think are beneficial gets reduced, and the colonies considered to be more harmful proliferate,” she explained.
What Does the Science Tell Us?
Numerous studies published in the past 5 years have linked chronic stress to modest but reproducible shifts in the composition of the microbiome.
A study of frontline healthcare workers during COVID-19 revealed that the pandemic was associated with significant depression, anxiety, and stress, as well as gut dysbiosis that persisted for at least half a year.
Notably, healthcare workers had low gut alpha diversity, indicating a less resilient and diverse microbiome, a state often associated with dysbiosis and increased risk for various diseases and negative health outcomes.
A two-cohort study of healthy adults found higher alpha diversity in those reporting low stress levels. It also found a link between stress and enriched levels of Escherichia/Shigella, an overgrowth of which has been linked to various conditions, including inflammatory bowel disease.
In addition, a 2023 systematic review of human studies concluded that stress is associated with changes in specific genera — namely reductions in gut-healthy Lachnospira/Lachnospiraceae and Phascolarctobacterium, which produce beneficial short-chain fatty acids that support the health of the intestinal lining and modulate the immune system.
Stress during specific life stages also appears to alter the gut microbiome.
For example, in a study of postpartum women, those at an increased risk for parenting stress showed lower alpha diversity on the Shannon diversity index.
Research involving mother-child pairs tied adversity — such as maltreatment of the mother during her childhood, prenatal anxiety, and hardship in the child’s early life — to distinct microbiome profiles in 2-year-olds, supporting a stress-microbiome pathway relevant to socioemotional outcomes, the authors said.
Emerging evidence indicates a link between the gut microbiome and posttraumatic stress disorder (PTSD).
A recent systematic review found differences in gut microbial taxa between individuals with PTSD and trauma-exposed controls without PTSD. A separate analysis pointed to a potential causal impact of gut microbiomes on the development of PTSD.
Mechanisms Behind the Link
Stress interferes with the brain’s production of neurotransmitters, such as serotonin, which controls anxiety, mood, sleep, and many other functions in the brain, Shaukat told GI & Hepatology News.
“But serotonin also crosses the blood-brain barrier, and actually, the gut has more serotonin receptors than the brain, so an imbalance of serotonin can actually affect the gut microbiome through signaling at the neurotransmitter level,” Shaukat explained.
Stress can also affect sleep, and sleep itself has regulatory properties for gut bacteria, Shaukat noted.
“Stress also lowers our immunity, and this can make the gut barrier susceptible or permeable to bacterial toxins that can pass through and breach the gut barrier and be released into the bloodstream, which can trigger inflammation,” Shaukat explained.
Implications for Patient Care
The gut-brain-microbiome axis remains an emerging field of study. “We’re learning more and more about this, and we need to because the microbial colonies are so diverse and we haven’t nailed it down yet,” Shaukat said.
In the meantime, what can clinicians tell patients?
Aside from managing stress, which “is easier said than done,” patients can improve their diet, Shaukat said.
“What we tell patients is to essentially increase their intake of gut-friendly foods that preferentially grow the bacterial colonies that are beneficial for us,” Shaukat said. This includes fermented foods, yogurt, kimchi, chia seeds, kombucha, pickled vegetables, and whole grains.
A recent randomized controlled trial of healthy adults found a “psychobiotic diet” — a diet high in prebiotic and fermented foods — was associated with less perceived stress and subtle beneficial shifts in microbial composition.
“These foods can help keep the gut in good health and may actually also reduce or mitigate some of the effects of stress,” Shaukat said.
“Eating well is something I think we should all think about and maybe prioritize when we’re going through a stressful situation or looking to kind of mitigate the effects of stress and the anxiety and depression it can cause,” she advised.
Shaukat said she also encourages patients to engage in regular physical activity, which benefits the gut microbiome by helping to regulate gut motility. Exercise can also boost mood and help relieve stress.
“A balanced Mediterranean diet and regular activity is truly the secret for gut health,” Shaukat said.
Patients may be tempted by the probiotic supplements lining drugstore shelves, but there “isn’t great evidence for probiotic supplements,” she said. “What we can get from dietary sources far outweighs what can be put in a pill.”
Shaukat disclosed having no relevant disclosures.
A version of this article appeared on Medscape.com.
Chronic psychological stress is common. A 2023 survey revealed that about one quarter of US adults reported high stress levels, and three quarters reported that chronic stress affects their daily lives.
Emerging evidence suggests that chronic stress not only exacts a high toll on mental health but also can wreak havoc on all levels of gastrointestinal (GI) functioning, all the way down to the microbiome.
Aasma Shaukat, MD, MPH, AGAF, gastroenterologist with NYU Langone Health and director of GI Outcomes Research, Gastroenterology at NYU Grossman School of Medicine in New York City, said in an interview with GI & Hepatology News.
“This basically means that the normal balance of microorganisms that essentially we think are beneficial gets reduced, and the colonies considered to be more harmful proliferate,” she explained.
What Does the Science Tell Us?
Numerous studies published in the past 5 years have linked chronic stress to modest but reproducible shifts in the composition of the microbiome.
A study of frontline healthcare workers during COVID-19 revealed that the pandemic was associated with significant depression, anxiety, and stress, as well as gut dysbiosis that persisted for at least half a year.
Notably, healthcare workers had low gut alpha diversity, indicating a less resilient and diverse microbiome, a state often associated with dysbiosis and increased risk for various diseases and negative health outcomes.
A two-cohort study of healthy adults found higher alpha diversity in those reporting low stress levels. It also found a link between stress and enriched levels of Escherichia/Shigella, an overgrowth of which has been linked to various conditions, including inflammatory bowel disease.
In addition, a 2023 systematic review of human studies concluded that stress is associated with changes in specific genera — namely reductions in gut-healthy Lachnospira/Lachnospiraceae and Phascolarctobacterium, which produce beneficial short-chain fatty acids that support the health of the intestinal lining and modulate the immune system.
Stress during specific life stages also appears to alter the gut microbiome.
For example, in a study of postpartum women, those at an increased risk for parenting stress showed lower alpha diversity on the Shannon diversity index.
Research involving mother-child pairs tied adversity — such as maltreatment of the mother during her childhood, prenatal anxiety, and hardship in the child’s early life — to distinct microbiome profiles in 2-year-olds, supporting a stress-microbiome pathway relevant to socioemotional outcomes, the authors said.
Emerging evidence indicates a link between the gut microbiome and posttraumatic stress disorder (PTSD).
A recent systematic review found differences in gut microbial taxa between individuals with PTSD and trauma-exposed controls without PTSD. A separate analysis pointed to a potential causal impact of gut microbiomes on the development of PTSD.
Mechanisms Behind the Link
Stress interferes with the brain’s production of neurotransmitters, such as serotonin, which controls anxiety, mood, sleep, and many other functions in the brain, Shaukat told GI & Hepatology News.
“But serotonin also crosses the blood-brain barrier, and actually, the gut has more serotonin receptors than the brain, so an imbalance of serotonin can actually affect the gut microbiome through signaling at the neurotransmitter level,” Shaukat explained.
Stress can also affect sleep, and sleep itself has regulatory properties for gut bacteria, Shaukat noted.
“Stress also lowers our immunity, and this can make the gut barrier susceptible or permeable to bacterial toxins that can pass through and breach the gut barrier and be released into the bloodstream, which can trigger inflammation,” Shaukat explained.
Implications for Patient Care
The gut-brain-microbiome axis remains an emerging field of study. “We’re learning more and more about this, and we need to because the microbial colonies are so diverse and we haven’t nailed it down yet,” Shaukat said.
In the meantime, what can clinicians tell patients?
Aside from managing stress, which “is easier said than done,” patients can improve their diet, Shaukat said.
“What we tell patients is to essentially increase their intake of gut-friendly foods that preferentially grow the bacterial colonies that are beneficial for us,” Shaukat said. This includes fermented foods, yogurt, kimchi, chia seeds, kombucha, pickled vegetables, and whole grains.
A recent randomized controlled trial of healthy adults found a “psychobiotic diet” — a diet high in prebiotic and fermented foods — was associated with less perceived stress and subtle beneficial shifts in microbial composition.
“These foods can help keep the gut in good health and may actually also reduce or mitigate some of the effects of stress,” Shaukat said.
“Eating well is something I think we should all think about and maybe prioritize when we’re going through a stressful situation or looking to kind of mitigate the effects of stress and the anxiety and depression it can cause,” she advised.
Shaukat said she also encourages patients to engage in regular physical activity, which benefits the gut microbiome by helping to regulate gut motility. Exercise can also boost mood and help relieve stress.
“A balanced Mediterranean diet and regular activity is truly the secret for gut health,” Shaukat said.
Patients may be tempted by the probiotic supplements lining drugstore shelves, but there “isn’t great evidence for probiotic supplements,” she said. “What we can get from dietary sources far outweighs what can be put in a pill.”
Shaukat disclosed having no relevant disclosures.
A version of this article appeared on Medscape.com.
Chronic psychological stress is common. A 2023 survey revealed that about one quarter of US adults reported high stress levels, and three quarters reported that chronic stress affects their daily lives.
Emerging evidence suggests that chronic stress not only exacts a high toll on mental health but also can wreak havoc on all levels of gastrointestinal (GI) functioning, all the way down to the microbiome.
Aasma Shaukat, MD, MPH, AGAF, gastroenterologist with NYU Langone Health and director of GI Outcomes Research, Gastroenterology at NYU Grossman School of Medicine in New York City, said in an interview with GI & Hepatology News.
“This basically means that the normal balance of microorganisms that essentially we think are beneficial gets reduced, and the colonies considered to be more harmful proliferate,” she explained.
What Does the Science Tell Us?
Numerous studies published in the past 5 years have linked chronic stress to modest but reproducible shifts in the composition of the microbiome.
A study of frontline healthcare workers during COVID-19 revealed that the pandemic was associated with significant depression, anxiety, and stress, as well as gut dysbiosis that persisted for at least half a year.
Notably, healthcare workers had low gut alpha diversity, indicating a less resilient and diverse microbiome, a state often associated with dysbiosis and increased risk for various diseases and negative health outcomes.
A two-cohort study of healthy adults found higher alpha diversity in those reporting low stress levels. It also found a link between stress and enriched levels of Escherichia/Shigella, an overgrowth of which has been linked to various conditions, including inflammatory bowel disease.
In addition, a 2023 systematic review of human studies concluded that stress is associated with changes in specific genera — namely reductions in gut-healthy Lachnospira/Lachnospiraceae and Phascolarctobacterium, which produce beneficial short-chain fatty acids that support the health of the intestinal lining and modulate the immune system.
Stress during specific life stages also appears to alter the gut microbiome.
For example, in a study of postpartum women, those at an increased risk for parenting stress showed lower alpha diversity on the Shannon diversity index.
Research involving mother-child pairs tied adversity — such as maltreatment of the mother during her childhood, prenatal anxiety, and hardship in the child’s early life — to distinct microbiome profiles in 2-year-olds, supporting a stress-microbiome pathway relevant to socioemotional outcomes, the authors said.
Emerging evidence indicates a link between the gut microbiome and posttraumatic stress disorder (PTSD).
A recent systematic review found differences in gut microbial taxa between individuals with PTSD and trauma-exposed controls without PTSD. A separate analysis pointed to a potential causal impact of gut microbiomes on the development of PTSD.
Mechanisms Behind the Link
Stress interferes with the brain’s production of neurotransmitters, such as serotonin, which controls anxiety, mood, sleep, and many other functions in the brain, Shaukat told GI & Hepatology News.
“But serotonin also crosses the blood-brain barrier, and actually, the gut has more serotonin receptors than the brain, so an imbalance of serotonin can actually affect the gut microbiome through signaling at the neurotransmitter level,” Shaukat explained.
Stress can also affect sleep, and sleep itself has regulatory properties for gut bacteria, Shaukat noted.
“Stress also lowers our immunity, and this can make the gut barrier susceptible or permeable to bacterial toxins that can pass through and breach the gut barrier and be released into the bloodstream, which can trigger inflammation,” Shaukat explained.
Implications for Patient Care
The gut-brain-microbiome axis remains an emerging field of study. “We’re learning more and more about this, and we need to because the microbial colonies are so diverse and we haven’t nailed it down yet,” Shaukat said.
In the meantime, what can clinicians tell patients?
Aside from managing stress, which “is easier said than done,” patients can improve their diet, Shaukat said.
“What we tell patients is to essentially increase their intake of gut-friendly foods that preferentially grow the bacterial colonies that are beneficial for us,” Shaukat said. This includes fermented foods, yogurt, kimchi, chia seeds, kombucha, pickled vegetables, and whole grains.
A recent randomized controlled trial of healthy adults found a “psychobiotic diet” — a diet high in prebiotic and fermented foods — was associated with less perceived stress and subtle beneficial shifts in microbial composition.
“These foods can help keep the gut in good health and may actually also reduce or mitigate some of the effects of stress,” Shaukat said.
“Eating well is something I think we should all think about and maybe prioritize when we’re going through a stressful situation or looking to kind of mitigate the effects of stress and the anxiety and depression it can cause,” she advised.
Shaukat said she also encourages patients to engage in regular physical activity, which benefits the gut microbiome by helping to regulate gut motility. Exercise can also boost mood and help relieve stress.
“A balanced Mediterranean diet and regular activity is truly the secret for gut health,” Shaukat said.
Patients may be tempted by the probiotic supplements lining drugstore shelves, but there “isn’t great evidence for probiotic supplements,” she said. “What we can get from dietary sources far outweighs what can be put in a pill.”
Shaukat disclosed having no relevant disclosures.
A version of this article appeared on Medscape.com.
IBD 101: Intensive Course for GI Fellows Boosts Clinical Confidence
Results from the initial pilot program in 2019, called “IBD 101: Physicians and Patients Providing Pearls and Perspectives” are outlined in Inflammatory Bowel Diseases by Lisa Malter, MD, AGAF, a professor of medicine in the Division of Gastroenterology at NYU Langone Grossman School of Medicine, New York City, and colleagues.
The course, conducted by Malter at NYU Langone’s simulation center, was designed to increase fellows’ early exposure to the complexities of IBD and its diagnosis and management in the context of rapidly changing therapies and variability across US GI training programs. The authors reported that the 2019 program was well received, with attendees showing “increased comfort and sustained benefit” in discussing IBD management with patients. Notably, participants’ increased comfort levels in broaching IBD topics persisted 3 years after the course compared with that of nonparticipating peers, pointing to potential improved patient care after completion of training.
“At this point, 1 in every 100 GI patients has IBD. It’s one of the more complex GI conditions and its incidence and prevalence are increasing globally,” Malter told GI & Hepatology News. Prevalence rates in the US are reportedly as high as 464.5 per 100,000 persons.
“In addition, its management has become more complicated with newer medications and treatments coming on stream,” she said. “An educational gap exists.”
The Program
The course provided an intimate, interactive format with national experts in the field serving as faculty. Course objectives included basic, introductory information on the diagnosis, treatment, and management of IBD; early exposure to IBD as a subspecialty to allow registrants to make informed career decisions; and information about other educational opportunities.
The course was designed to raise participants’ comfort levels in discussing seven topics with patients, including the need for surgery, IBD in pregnancy, treatment escalation in different disease scenarios, and lack of treatment response.
The three-part course, featuring case scenarios, was offered in person to 60 fellows selected by regional GI fellowship program directors and course faculty, which consisted of a director, three codirectors, and 14 local and national IBD experts. A half-day training session for faculty was held immediately before the course.
In September 2019, the first 32 fellows from Accreditation Council for Graduate Medical Education-accredited programs participated in IBD 101. A total of 49 (89%) of 55 participants completed presession and immediate postsession surveys.
In the 3-year follow-up survey, among 36 fellows, of whom 21 (58%) attended IBD 101 and 15 (42%) did not, attendees reported overall IBD confidence and equivalent or higher levels of comfort in discussing each of seven topics.
Among the specific survey findings:
- 100% said the course had improved their ability to effectively treat and manage patients
- A higher proportion of attendees strongly agreed with having comfort in discussing pregnancy in IBD (43% vs 13%; P = .08)
- A statistically significant proportion strongly agreed with having comfort in discussing loss of response to biologics (62% vs 27%; P = .049)
- 98% reported increased interest in exploring IBD during fellowship
- 100% noted improved understanding of supplemental opportunities to learn about IBD
- 96% would strongly recommend this course to future GI fellows
Further testimony to the effectiveness of the ongoing course, said Malter, is that the version offered in 2024 attracted 425 GI fellows from across the country. “That’s about 90% of US GI fellows,” she said.
Offering an outsider’s perspective on the results of the course, Ashwin N. Ananthakrishnan, MBBS, MPH, AGAF, a director or the Crohn’s and Colitis Center at Massachusetts General Hospital in Boston, said, “It’s a useful update. It’s always good to see benefits from educational courses.” He expressed caution, however, “in that a small subset of GI fellows always selects toward those with greater IBD interest. Consequently, they likely have participated in several other IBD education activities in the intervening 3 years — so one can’t attribute benefit to this course alone.”
And while one effect of such courses may to increase the number of IBD-interested trainees, their role in providing IBD education to gastroenterologists who will not specialize in IBD is more important, Ananthakrishnan added. “These general gastroenterologists are going to be managing a lot of the IBD in the community, so in my opinion, ensuring they are comfortable with caring for IBD patients optimally is more important than training IBD specialists, who have many opportunities for education.”
In collaboration with the American College of Gastroenterology, the course is open to all first-year GI fellows training in North America. The most recent program was held on September 13, 2025.
This paper received no specific funding. The IBD course has been supported by unrestricted educational grants from Pfizer and Takeda Pharmaceuticals and sponsorships from AbbVie, Janssen, and Prometheus Labs.Malter reported receiving educational grants from AbbVie, Janssen, Pfizer, and Takeda; serving as a consultant for Abbvie and Pharmacosmos; and serving on the advisory boards for AbbVie, Bristol Myers Squibb, Celltrion, Janssen, Merck, and Takeda. Multiple coauthors disclosed similar relationships with numerous private-sector companies.
A version of this article appeared on Medscape.com.
Results from the initial pilot program in 2019, called “IBD 101: Physicians and Patients Providing Pearls and Perspectives” are outlined in Inflammatory Bowel Diseases by Lisa Malter, MD, AGAF, a professor of medicine in the Division of Gastroenterology at NYU Langone Grossman School of Medicine, New York City, and colleagues.
The course, conducted by Malter at NYU Langone’s simulation center, was designed to increase fellows’ early exposure to the complexities of IBD and its diagnosis and management in the context of rapidly changing therapies and variability across US GI training programs. The authors reported that the 2019 program was well received, with attendees showing “increased comfort and sustained benefit” in discussing IBD management with patients. Notably, participants’ increased comfort levels in broaching IBD topics persisted 3 years after the course compared with that of nonparticipating peers, pointing to potential improved patient care after completion of training.
“At this point, 1 in every 100 GI patients has IBD. It’s one of the more complex GI conditions and its incidence and prevalence are increasing globally,” Malter told GI & Hepatology News. Prevalence rates in the US are reportedly as high as 464.5 per 100,000 persons.
“In addition, its management has become more complicated with newer medications and treatments coming on stream,” she said. “An educational gap exists.”
The Program
The course provided an intimate, interactive format with national experts in the field serving as faculty. Course objectives included basic, introductory information on the diagnosis, treatment, and management of IBD; early exposure to IBD as a subspecialty to allow registrants to make informed career decisions; and information about other educational opportunities.
The course was designed to raise participants’ comfort levels in discussing seven topics with patients, including the need for surgery, IBD in pregnancy, treatment escalation in different disease scenarios, and lack of treatment response.
The three-part course, featuring case scenarios, was offered in person to 60 fellows selected by regional GI fellowship program directors and course faculty, which consisted of a director, three codirectors, and 14 local and national IBD experts. A half-day training session for faculty was held immediately before the course.
In September 2019, the first 32 fellows from Accreditation Council for Graduate Medical Education-accredited programs participated in IBD 101. A total of 49 (89%) of 55 participants completed presession and immediate postsession surveys.
In the 3-year follow-up survey, among 36 fellows, of whom 21 (58%) attended IBD 101 and 15 (42%) did not, attendees reported overall IBD confidence and equivalent or higher levels of comfort in discussing each of seven topics.
Among the specific survey findings:
- 100% said the course had improved their ability to effectively treat and manage patients
- A higher proportion of attendees strongly agreed with having comfort in discussing pregnancy in IBD (43% vs 13%; P = .08)
- A statistically significant proportion strongly agreed with having comfort in discussing loss of response to biologics (62% vs 27%; P = .049)
- 98% reported increased interest in exploring IBD during fellowship
- 100% noted improved understanding of supplemental opportunities to learn about IBD
- 96% would strongly recommend this course to future GI fellows
Further testimony to the effectiveness of the ongoing course, said Malter, is that the version offered in 2024 attracted 425 GI fellows from across the country. “That’s about 90% of US GI fellows,” she said.
Offering an outsider’s perspective on the results of the course, Ashwin N. Ananthakrishnan, MBBS, MPH, AGAF, a director or the Crohn’s and Colitis Center at Massachusetts General Hospital in Boston, said, “It’s a useful update. It’s always good to see benefits from educational courses.” He expressed caution, however, “in that a small subset of GI fellows always selects toward those with greater IBD interest. Consequently, they likely have participated in several other IBD education activities in the intervening 3 years — so one can’t attribute benefit to this course alone.”
And while one effect of such courses may to increase the number of IBD-interested trainees, their role in providing IBD education to gastroenterologists who will not specialize in IBD is more important, Ananthakrishnan added. “These general gastroenterologists are going to be managing a lot of the IBD in the community, so in my opinion, ensuring they are comfortable with caring for IBD patients optimally is more important than training IBD specialists, who have many opportunities for education.”
In collaboration with the American College of Gastroenterology, the course is open to all first-year GI fellows training in North America. The most recent program was held on September 13, 2025.
This paper received no specific funding. The IBD course has been supported by unrestricted educational grants from Pfizer and Takeda Pharmaceuticals and sponsorships from AbbVie, Janssen, and Prometheus Labs.Malter reported receiving educational grants from AbbVie, Janssen, Pfizer, and Takeda; serving as a consultant for Abbvie and Pharmacosmos; and serving on the advisory boards for AbbVie, Bristol Myers Squibb, Celltrion, Janssen, Merck, and Takeda. Multiple coauthors disclosed similar relationships with numerous private-sector companies.
A version of this article appeared on Medscape.com.
Results from the initial pilot program in 2019, called “IBD 101: Physicians and Patients Providing Pearls and Perspectives” are outlined in Inflammatory Bowel Diseases by Lisa Malter, MD, AGAF, a professor of medicine in the Division of Gastroenterology at NYU Langone Grossman School of Medicine, New York City, and colleagues.
The course, conducted by Malter at NYU Langone’s simulation center, was designed to increase fellows’ early exposure to the complexities of IBD and its diagnosis and management in the context of rapidly changing therapies and variability across US GI training programs. The authors reported that the 2019 program was well received, with attendees showing “increased comfort and sustained benefit” in discussing IBD management with patients. Notably, participants’ increased comfort levels in broaching IBD topics persisted 3 years after the course compared with that of nonparticipating peers, pointing to potential improved patient care after completion of training.
“At this point, 1 in every 100 GI patients has IBD. It’s one of the more complex GI conditions and its incidence and prevalence are increasing globally,” Malter told GI & Hepatology News. Prevalence rates in the US are reportedly as high as 464.5 per 100,000 persons.
“In addition, its management has become more complicated with newer medications and treatments coming on stream,” she said. “An educational gap exists.”
The Program
The course provided an intimate, interactive format with national experts in the field serving as faculty. Course objectives included basic, introductory information on the diagnosis, treatment, and management of IBD; early exposure to IBD as a subspecialty to allow registrants to make informed career decisions; and information about other educational opportunities.
The course was designed to raise participants’ comfort levels in discussing seven topics with patients, including the need for surgery, IBD in pregnancy, treatment escalation in different disease scenarios, and lack of treatment response.
The three-part course, featuring case scenarios, was offered in person to 60 fellows selected by regional GI fellowship program directors and course faculty, which consisted of a director, three codirectors, and 14 local and national IBD experts. A half-day training session for faculty was held immediately before the course.
In September 2019, the first 32 fellows from Accreditation Council for Graduate Medical Education-accredited programs participated in IBD 101. A total of 49 (89%) of 55 participants completed presession and immediate postsession surveys.
In the 3-year follow-up survey, among 36 fellows, of whom 21 (58%) attended IBD 101 and 15 (42%) did not, attendees reported overall IBD confidence and equivalent or higher levels of comfort in discussing each of seven topics.
Among the specific survey findings:
- 100% said the course had improved their ability to effectively treat and manage patients
- A higher proportion of attendees strongly agreed with having comfort in discussing pregnancy in IBD (43% vs 13%; P = .08)
- A statistically significant proportion strongly agreed with having comfort in discussing loss of response to biologics (62% vs 27%; P = .049)
- 98% reported increased interest in exploring IBD during fellowship
- 100% noted improved understanding of supplemental opportunities to learn about IBD
- 96% would strongly recommend this course to future GI fellows
Further testimony to the effectiveness of the ongoing course, said Malter, is that the version offered in 2024 attracted 425 GI fellows from across the country. “That’s about 90% of US GI fellows,” she said.
Offering an outsider’s perspective on the results of the course, Ashwin N. Ananthakrishnan, MBBS, MPH, AGAF, a director or the Crohn’s and Colitis Center at Massachusetts General Hospital in Boston, said, “It’s a useful update. It’s always good to see benefits from educational courses.” He expressed caution, however, “in that a small subset of GI fellows always selects toward those with greater IBD interest. Consequently, they likely have participated in several other IBD education activities in the intervening 3 years — so one can’t attribute benefit to this course alone.”
And while one effect of such courses may to increase the number of IBD-interested trainees, their role in providing IBD education to gastroenterologists who will not specialize in IBD is more important, Ananthakrishnan added. “These general gastroenterologists are going to be managing a lot of the IBD in the community, so in my opinion, ensuring they are comfortable with caring for IBD patients optimally is more important than training IBD specialists, who have many opportunities for education.”
In collaboration with the American College of Gastroenterology, the course is open to all first-year GI fellows training in North America. The most recent program was held on September 13, 2025.
This paper received no specific funding. The IBD course has been supported by unrestricted educational grants from Pfizer and Takeda Pharmaceuticals and sponsorships from AbbVie, Janssen, and Prometheus Labs.Malter reported receiving educational grants from AbbVie, Janssen, Pfizer, and Takeda; serving as a consultant for Abbvie and Pharmacosmos; and serving on the advisory boards for AbbVie, Bristol Myers Squibb, Celltrion, Janssen, Merck, and Takeda. Multiple coauthors disclosed similar relationships with numerous private-sector companies.
A version of this article appeared on Medscape.com.
Could a Clinical Decision Support Tool Improve Outcomes in Pediatric Diarrhea?
“Clinical decision support tools are designed to assist clinicians in making informed and accurate diagnostic and prognostic decisions using available characteristics of the patient and the larger context,” Anna Jones, MD, MPH, and her colleagues wrote in JAMA Network Open.
Jones is in the Department of Pediatrics at the University of Utah School of Medicine in Salt Lake City.
Jones and her coauthors concluded such a tool had the potential to improve evidence-based testing in pediatric diarrhea and help clinicians communicate clearly to parents the etiology of their child’s illness. Parents in the study, however, expressed skepticism over the tool, voicing concerns that physicians might over-rely on its algorithms.
The authors said that thanks to the development of multiplex polymerase chain reaction (PCR) panels for gastroenteritis, it is now possible to quickly identify up to 22 different pathogens from stool samples. What is lacking, they suggested, are protocols for knowing when to test for these pathogens.
“Although the Infectious Diseases Society of America 2017 clinical practice guidelines for the diagnosis and management of infectious diarrhea provide broad recommendations for when diarrhea-related diagnostics should be used, clear guidelines specific to the use of multiplex PCR panels do not exist,” Jones and her coauthors wrote, adding that misusing the diagnostics, however, “can lead to inappropriate antibiotic use and excess financial burdens.”
Meanwhile, communication breakdowns in the patient-doctor relationship are a leading contributor to diagnostic errors, according to the Agency for Healthcare Research and Quality. Subsequently, the National Academy of Medicine has recommended that healthcare professionals seek to engage patients and their families in the diagnostic process.
With these factors in mind, Jones and her colleagues recruited parents who had sought care for their child’s diarrhea and clinicians who routinely treat children with diarrhea. The recruits came from five urgent care sites and one emergency department (ED), all in Utah. Participants were interviewed between June 15, 2023, and January 24, 2025.
In all, the authors interviewed 44 parents (40 women; median age, 34 years). One parent (2%) identified as Asian, two (5%) as Black or African American, 15 (34%) as Hispanic or Latin, and 22 (50%) as White individuals. The remaining four participants (9%) were of unknown race and ethnicity. Most parents spoke English as their primary language (40 [91%]).
Among the 16 clinicians, 10 were physicians and six were nurse practitioners or physician associates. Eleven of the 16 were women and the group had a median age of 42 years. Fourteen clinicians (88%) self-identified as White individuals and two (13%) had unknown race and ethnicity.
All were interviewed on their management of pediatric diarrhea and about their expectations for diagnostic testing and treatment of the condition, as well as the perceived utility of a clinical decision support tool.
Jones and colleagues identified three motivations among parents who sought clinical care for a child with diarrhea. The first was reassurance, which the authors said included validation for what the parents were already doing to care for their child.
The second motivation was to obtain insight into the etiology of their child’s symptoms. “Many believed that diagnostic testing to identify the specific etiology of the illness would be useful. Parents indicated that knowing the etiology would offer desired reassurance and potentially inform treatment decisions,” Jones and her coauthors wrote.
Lastly, parents sought appropriate treatment and symptom relief.
Many clinicians acknowledged the benefits of a clinical decision support tool for help with evidence-based decision-making during diagnosis and to facilitate communication with families. However, they expressed skepticism over the use of diagnostics for etiology, noting that disease management was not dependent upon knowing it.
Some clinicians said many families expected a test. “Even if I don’t think that a GI [gastrointestinal] stool study is necessary, there are situations where…a family is not going to leave the [ED] happy without one. And so I probably order them sometimes when they’re not truly indicated,” a physician reported in the interview.
“That said,” Jones and her coauthors wrote, “clinicians thought that diagnostic testing for pediatric diarrhea was generally not warranted, except in unique cases [such as] bloody stools, prolonged duration of diarrhea, or travel history.”
Many clinicians thought a decision-making tool might help build trust and rapport with the patient’s family, reassuring them their child is getting evidence-based care.
“It just adds to that shared decision-making model. I think it adds trust…I think it does kind of back up our ability to defend why we’re doing what we’re doing,” reported one surveyed ED physician.
Parents were mostly wary of the potential use of a clinical decision-making tool. Jones and colleagues reported that in addition to some clinicians, “several parents expressed concerns that a tool does not account for nuances and would lead to ‘generalizing every kid’ (said the father of a child aged 1-3 years), as opposed to providing patient-centered care.”
Parents also said they worried a clinician would not reply upon their own clinical judgement if they had a diagnostic tool.
Jones and her colleagues concluded that before implementing a clinical decision support tool in pediatric diarrhea, strategies are necessary to, “resolve tension in care expectations, facilitate diagnostic stewardship, and optimize care.”
In an accompanying editorial, KC Coffey, MD, MPH, concluded that the study by Jones and colleagues suggests that adapting such tools to incorporate parental expectations, “could facilitate patient engagement in the diagnostic process and increase acceptance of [using these tools for] decisions. Such discussions might also raise awareness of the potential harms of over testing.” Coffey is an epidemiologist and infectious disease physician at the University of Maryland in Baltimore.
Elizabeth Dobler, MD, who was not involved in the study, told GI & Hepatology News that “as the number of available tests continues to grow, stewardship is becoming more relevant than ever. Families may not always realize the downsides of unnecessary testing — such as false positives, avoidable procedures, or added risks — and part of our responsibility is to help them understand both the potential benefits and the potential harms of these tests.”
Dobler is the medical director for clinical decision support in the Department of Clinical Informatics at Ann & Robert H. Lurie Children’s Hospital of Chicago, Chicago.
Clinical decision support tools are helpful in the clinical setting, Dobler said because “they give providers quick access to the most relevant information needed for decision-making. This includes patient-specific details — symptoms, history, labs, and vitals” as well as the characteristics and downsides of the tests. In an ideal world, she said, clinicians would consider these data for every patient.
Dobler cautioned however, that, “it’s important to stress that these tools don’t replace clinical judgment — the provider still evaluates the patient, considers the clinical context, and incorporates the family’s preferences. But as a complement to that process, I believe these tools are very valuable.”
Lastly, Dobler said that transparency is key to helping parents overcome their hesitancy regarding these tools.
Jones, Coffey, and Dobler reported no relevant financial disclosures.
A version of this article appeared on Medscape.com.
“Clinical decision support tools are designed to assist clinicians in making informed and accurate diagnostic and prognostic decisions using available characteristics of the patient and the larger context,” Anna Jones, MD, MPH, and her colleagues wrote in JAMA Network Open.
Jones is in the Department of Pediatrics at the University of Utah School of Medicine in Salt Lake City.
Jones and her coauthors concluded such a tool had the potential to improve evidence-based testing in pediatric diarrhea and help clinicians communicate clearly to parents the etiology of their child’s illness. Parents in the study, however, expressed skepticism over the tool, voicing concerns that physicians might over-rely on its algorithms.
The authors said that thanks to the development of multiplex polymerase chain reaction (PCR) panels for gastroenteritis, it is now possible to quickly identify up to 22 different pathogens from stool samples. What is lacking, they suggested, are protocols for knowing when to test for these pathogens.
“Although the Infectious Diseases Society of America 2017 clinical practice guidelines for the diagnosis and management of infectious diarrhea provide broad recommendations for when diarrhea-related diagnostics should be used, clear guidelines specific to the use of multiplex PCR panels do not exist,” Jones and her coauthors wrote, adding that misusing the diagnostics, however, “can lead to inappropriate antibiotic use and excess financial burdens.”
Meanwhile, communication breakdowns in the patient-doctor relationship are a leading contributor to diagnostic errors, according to the Agency for Healthcare Research and Quality. Subsequently, the National Academy of Medicine has recommended that healthcare professionals seek to engage patients and their families in the diagnostic process.
With these factors in mind, Jones and her colleagues recruited parents who had sought care for their child’s diarrhea and clinicians who routinely treat children with diarrhea. The recruits came from five urgent care sites and one emergency department (ED), all in Utah. Participants were interviewed between June 15, 2023, and January 24, 2025.
In all, the authors interviewed 44 parents (40 women; median age, 34 years). One parent (2%) identified as Asian, two (5%) as Black or African American, 15 (34%) as Hispanic or Latin, and 22 (50%) as White individuals. The remaining four participants (9%) were of unknown race and ethnicity. Most parents spoke English as their primary language (40 [91%]).
Among the 16 clinicians, 10 were physicians and six were nurse practitioners or physician associates. Eleven of the 16 were women and the group had a median age of 42 years. Fourteen clinicians (88%) self-identified as White individuals and two (13%) had unknown race and ethnicity.
All were interviewed on their management of pediatric diarrhea and about their expectations for diagnostic testing and treatment of the condition, as well as the perceived utility of a clinical decision support tool.
Jones and colleagues identified three motivations among parents who sought clinical care for a child with diarrhea. The first was reassurance, which the authors said included validation for what the parents were already doing to care for their child.
The second motivation was to obtain insight into the etiology of their child’s symptoms. “Many believed that diagnostic testing to identify the specific etiology of the illness would be useful. Parents indicated that knowing the etiology would offer desired reassurance and potentially inform treatment decisions,” Jones and her coauthors wrote.
Lastly, parents sought appropriate treatment and symptom relief.
Many clinicians acknowledged the benefits of a clinical decision support tool for help with evidence-based decision-making during diagnosis and to facilitate communication with families. However, they expressed skepticism over the use of diagnostics for etiology, noting that disease management was not dependent upon knowing it.
Some clinicians said many families expected a test. “Even if I don’t think that a GI [gastrointestinal] stool study is necessary, there are situations where…a family is not going to leave the [ED] happy without one. And so I probably order them sometimes when they’re not truly indicated,” a physician reported in the interview.
“That said,” Jones and her coauthors wrote, “clinicians thought that diagnostic testing for pediatric diarrhea was generally not warranted, except in unique cases [such as] bloody stools, prolonged duration of diarrhea, or travel history.”
Many clinicians thought a decision-making tool might help build trust and rapport with the patient’s family, reassuring them their child is getting evidence-based care.
“It just adds to that shared decision-making model. I think it adds trust…I think it does kind of back up our ability to defend why we’re doing what we’re doing,” reported one surveyed ED physician.
Parents were mostly wary of the potential use of a clinical decision-making tool. Jones and colleagues reported that in addition to some clinicians, “several parents expressed concerns that a tool does not account for nuances and would lead to ‘generalizing every kid’ (said the father of a child aged 1-3 years), as opposed to providing patient-centered care.”
Parents also said they worried a clinician would not reply upon their own clinical judgement if they had a diagnostic tool.
Jones and her colleagues concluded that before implementing a clinical decision support tool in pediatric diarrhea, strategies are necessary to, “resolve tension in care expectations, facilitate diagnostic stewardship, and optimize care.”
In an accompanying editorial, KC Coffey, MD, MPH, concluded that the study by Jones and colleagues suggests that adapting such tools to incorporate parental expectations, “could facilitate patient engagement in the diagnostic process and increase acceptance of [using these tools for] decisions. Such discussions might also raise awareness of the potential harms of over testing.” Coffey is an epidemiologist and infectious disease physician at the University of Maryland in Baltimore.
Elizabeth Dobler, MD, who was not involved in the study, told GI & Hepatology News that “as the number of available tests continues to grow, stewardship is becoming more relevant than ever. Families may not always realize the downsides of unnecessary testing — such as false positives, avoidable procedures, or added risks — and part of our responsibility is to help them understand both the potential benefits and the potential harms of these tests.”
Dobler is the medical director for clinical decision support in the Department of Clinical Informatics at Ann & Robert H. Lurie Children’s Hospital of Chicago, Chicago.
Clinical decision support tools are helpful in the clinical setting, Dobler said because “they give providers quick access to the most relevant information needed for decision-making. This includes patient-specific details — symptoms, history, labs, and vitals” as well as the characteristics and downsides of the tests. In an ideal world, she said, clinicians would consider these data for every patient.
Dobler cautioned however, that, “it’s important to stress that these tools don’t replace clinical judgment — the provider still evaluates the patient, considers the clinical context, and incorporates the family’s preferences. But as a complement to that process, I believe these tools are very valuable.”
Lastly, Dobler said that transparency is key to helping parents overcome their hesitancy regarding these tools.
Jones, Coffey, and Dobler reported no relevant financial disclosures.
A version of this article appeared on Medscape.com.
“Clinical decision support tools are designed to assist clinicians in making informed and accurate diagnostic and prognostic decisions using available characteristics of the patient and the larger context,” Anna Jones, MD, MPH, and her colleagues wrote in JAMA Network Open.
Jones is in the Department of Pediatrics at the University of Utah School of Medicine in Salt Lake City.
Jones and her coauthors concluded such a tool had the potential to improve evidence-based testing in pediatric diarrhea and help clinicians communicate clearly to parents the etiology of their child’s illness. Parents in the study, however, expressed skepticism over the tool, voicing concerns that physicians might over-rely on its algorithms.
The authors said that thanks to the development of multiplex polymerase chain reaction (PCR) panels for gastroenteritis, it is now possible to quickly identify up to 22 different pathogens from stool samples. What is lacking, they suggested, are protocols for knowing when to test for these pathogens.
“Although the Infectious Diseases Society of America 2017 clinical practice guidelines for the diagnosis and management of infectious diarrhea provide broad recommendations for when diarrhea-related diagnostics should be used, clear guidelines specific to the use of multiplex PCR panels do not exist,” Jones and her coauthors wrote, adding that misusing the diagnostics, however, “can lead to inappropriate antibiotic use and excess financial burdens.”
Meanwhile, communication breakdowns in the patient-doctor relationship are a leading contributor to diagnostic errors, according to the Agency for Healthcare Research and Quality. Subsequently, the National Academy of Medicine has recommended that healthcare professionals seek to engage patients and their families in the diagnostic process.
With these factors in mind, Jones and her colleagues recruited parents who had sought care for their child’s diarrhea and clinicians who routinely treat children with diarrhea. The recruits came from five urgent care sites and one emergency department (ED), all in Utah. Participants were interviewed between June 15, 2023, and January 24, 2025.
In all, the authors interviewed 44 parents (40 women; median age, 34 years). One parent (2%) identified as Asian, two (5%) as Black or African American, 15 (34%) as Hispanic or Latin, and 22 (50%) as White individuals. The remaining four participants (9%) were of unknown race and ethnicity. Most parents spoke English as their primary language (40 [91%]).
Among the 16 clinicians, 10 were physicians and six were nurse practitioners or physician associates. Eleven of the 16 were women and the group had a median age of 42 years. Fourteen clinicians (88%) self-identified as White individuals and two (13%) had unknown race and ethnicity.
All were interviewed on their management of pediatric diarrhea and about their expectations for diagnostic testing and treatment of the condition, as well as the perceived utility of a clinical decision support tool.
Jones and colleagues identified three motivations among parents who sought clinical care for a child with diarrhea. The first was reassurance, which the authors said included validation for what the parents were already doing to care for their child.
The second motivation was to obtain insight into the etiology of their child’s symptoms. “Many believed that diagnostic testing to identify the specific etiology of the illness would be useful. Parents indicated that knowing the etiology would offer desired reassurance and potentially inform treatment decisions,” Jones and her coauthors wrote.
Lastly, parents sought appropriate treatment and symptom relief.
Many clinicians acknowledged the benefits of a clinical decision support tool for help with evidence-based decision-making during diagnosis and to facilitate communication with families. However, they expressed skepticism over the use of diagnostics for etiology, noting that disease management was not dependent upon knowing it.
Some clinicians said many families expected a test. “Even if I don’t think that a GI [gastrointestinal] stool study is necessary, there are situations where…a family is not going to leave the [ED] happy without one. And so I probably order them sometimes when they’re not truly indicated,” a physician reported in the interview.
“That said,” Jones and her coauthors wrote, “clinicians thought that diagnostic testing for pediatric diarrhea was generally not warranted, except in unique cases [such as] bloody stools, prolonged duration of diarrhea, or travel history.”
Many clinicians thought a decision-making tool might help build trust and rapport with the patient’s family, reassuring them their child is getting evidence-based care.
“It just adds to that shared decision-making model. I think it adds trust…I think it does kind of back up our ability to defend why we’re doing what we’re doing,” reported one surveyed ED physician.
Parents were mostly wary of the potential use of a clinical decision-making tool. Jones and colleagues reported that in addition to some clinicians, “several parents expressed concerns that a tool does not account for nuances and would lead to ‘generalizing every kid’ (said the father of a child aged 1-3 years), as opposed to providing patient-centered care.”
Parents also said they worried a clinician would not reply upon their own clinical judgement if they had a diagnostic tool.
Jones and her colleagues concluded that before implementing a clinical decision support tool in pediatric diarrhea, strategies are necessary to, “resolve tension in care expectations, facilitate diagnostic stewardship, and optimize care.”
In an accompanying editorial, KC Coffey, MD, MPH, concluded that the study by Jones and colleagues suggests that adapting such tools to incorporate parental expectations, “could facilitate patient engagement in the diagnostic process and increase acceptance of [using these tools for] decisions. Such discussions might also raise awareness of the potential harms of over testing.” Coffey is an epidemiologist and infectious disease physician at the University of Maryland in Baltimore.
Elizabeth Dobler, MD, who was not involved in the study, told GI & Hepatology News that “as the number of available tests continues to grow, stewardship is becoming more relevant than ever. Families may not always realize the downsides of unnecessary testing — such as false positives, avoidable procedures, or added risks — and part of our responsibility is to help them understand both the potential benefits and the potential harms of these tests.”
Dobler is the medical director for clinical decision support in the Department of Clinical Informatics at Ann & Robert H. Lurie Children’s Hospital of Chicago, Chicago.
Clinical decision support tools are helpful in the clinical setting, Dobler said because “they give providers quick access to the most relevant information needed for decision-making. This includes patient-specific details — symptoms, history, labs, and vitals” as well as the characteristics and downsides of the tests. In an ideal world, she said, clinicians would consider these data for every patient.
Dobler cautioned however, that, “it’s important to stress that these tools don’t replace clinical judgment — the provider still evaluates the patient, considers the clinical context, and incorporates the family’s preferences. But as a complement to that process, I believe these tools are very valuable.”
Lastly, Dobler said that transparency is key to helping parents overcome their hesitancy regarding these tools.
Jones, Coffey, and Dobler reported no relevant financial disclosures.
A version of this article appeared on Medscape.com.
Are Probiotics for Pouchitis Prevention Worth the Cost?
, but its cost-effectiveness depends on relapse risk and may only be justified in patients who experience frequent relapses of pouchitis, a new analysis showed.
“Our findings highlight that while probiotic treatments can reduce the risk of this complication, their high costs limit their overall value for most patients,” lead author Gaurav Syal, MD, a gastroenterologist at UCLA Health, said in a statement.
“Our analysis can help guide shared decision-making between patients, clinicians, and payers to ensure resources are used where they can provide the most benefit,” Syal added.
The study was published online in Gastro Hep Advances.
Common Complication After Ulcerative Colitis Surgery
Pouchitis is a common complication in patients with ulcerative colitis who undergo restorative proctocolectomy with IPAA, with a cumulative incidence of around 48% at 2 years and 80% at 30 years.
Many patients who experience pouchitis have a single episode and respond well to short antibiotic courses. However, others develop recurrent or relapsing pouchitis, and 17% progress to a chronic form that can become dependent on antibiotics or refractory to antibiotics.
An eight-strain probiotic was shown to be effective in primary and secondary prevention of pouchitis in randomized, placebo-controlled trials.
Syal and colleagues sought to determine whether it’s worth the cost.
They constructed decision-tree models with Markov simulations to compare the risk for initial development and recurrence of pouchitis over a 2-year period between no prophylaxis and daily use of the eight-strain probiotic.
In the primary prophylaxis model, the cycle length was 2 weeks and pouchitis treatment sequence was ciprofloxacin, metronidazole and ciprofloxacin-tinidazole. In the secondary prophylaxis model, the cycle length was 4 weeks and pouchitis treatment sequence was initially the same as the primary prophylaxis model with the addition of vedolizumab and infliximab.
Costs were calculated from a US third-party payer perspective, using a willingness-to-pay threshold of $100,000 per quality-adjusted life year (QALY).
For primary prevention, the probiotic slightly increased QALYs compared with no probiotic (0.927 vs 0.918) but at a far higher cost ($2223 vs $299), resulting in an incremental cost-effectiveness ratio (ICER) of $236,076 per QALY — well above the accepted threshold.
In patients with infrequent relapses, probiotic use was slightly more effective than no use of probiotic (cumulative QALYs, 1.26 vs 1.24) but more expensive ($3370 vs $557), yielding an ICER of $153,011 per QALY — again above the accepted threshold.
However, sensitivity analyses revealed that the probiotic was cost-effective in patients with frequent relapsing pouchitis — defined as two or more episodes per year.
In this subgroup, the ICER dropped below the willingness-to-pay threshold of $100,000 per QALY, and in some scenarios, the probiotic even became the dominant strategy, meaning it was both more effective and less costly than no prophylaxis, the researchers noted.
Current guidelines from AGA on managing pouchitis suggest using probiotics to prevent recurrent episodes of pouchitis with a caveat that those who experience infrequent episodes may choose to avoid secondary prevention strategies.
“Our findings supplement the guidelines by confirming that the eight-strain probiotics can be cost-effective in frequent relapsing not in infrequent relapsing pouchitis,” the authors wrote.
They also noted that the probiotic cost itself was the biggest driver of results, accounting for 95% of the total cost in the primary prevention model. According to their analysis, reducing its price by half could make it a cost-effective option more broadly.
They also noted that probiotic prophylaxis could be cost-effective for patients at higher-than-average risk, such as those with primary sclerosing cholangitis (PSC), who have 4.2 times higher odds of developing pouchitis than peers without PSC.
But they cautioned that “further research is warranted on the effectiveness of the eight-strain probiotic for primary prevention of pouchitis in patients with ulcerative colitis and IPAA and PSC.”
The study had no financial support. Syal reported receiving research support from Pfizer.
A version of this article appeared on Medscape.com.
, but its cost-effectiveness depends on relapse risk and may only be justified in patients who experience frequent relapses of pouchitis, a new analysis showed.
“Our findings highlight that while probiotic treatments can reduce the risk of this complication, their high costs limit their overall value for most patients,” lead author Gaurav Syal, MD, a gastroenterologist at UCLA Health, said in a statement.
“Our analysis can help guide shared decision-making between patients, clinicians, and payers to ensure resources are used where they can provide the most benefit,” Syal added.
The study was published online in Gastro Hep Advances.
Common Complication After Ulcerative Colitis Surgery
Pouchitis is a common complication in patients with ulcerative colitis who undergo restorative proctocolectomy with IPAA, with a cumulative incidence of around 48% at 2 years and 80% at 30 years.
Many patients who experience pouchitis have a single episode and respond well to short antibiotic courses. However, others develop recurrent or relapsing pouchitis, and 17% progress to a chronic form that can become dependent on antibiotics or refractory to antibiotics.
An eight-strain probiotic was shown to be effective in primary and secondary prevention of pouchitis in randomized, placebo-controlled trials.
Syal and colleagues sought to determine whether it’s worth the cost.
They constructed decision-tree models with Markov simulations to compare the risk for initial development and recurrence of pouchitis over a 2-year period between no prophylaxis and daily use of the eight-strain probiotic.
In the primary prophylaxis model, the cycle length was 2 weeks and pouchitis treatment sequence was ciprofloxacin, metronidazole and ciprofloxacin-tinidazole. In the secondary prophylaxis model, the cycle length was 4 weeks and pouchitis treatment sequence was initially the same as the primary prophylaxis model with the addition of vedolizumab and infliximab.
Costs were calculated from a US third-party payer perspective, using a willingness-to-pay threshold of $100,000 per quality-adjusted life year (QALY).
For primary prevention, the probiotic slightly increased QALYs compared with no probiotic (0.927 vs 0.918) but at a far higher cost ($2223 vs $299), resulting in an incremental cost-effectiveness ratio (ICER) of $236,076 per QALY — well above the accepted threshold.
In patients with infrequent relapses, probiotic use was slightly more effective than no use of probiotic (cumulative QALYs, 1.26 vs 1.24) but more expensive ($3370 vs $557), yielding an ICER of $153,011 per QALY — again above the accepted threshold.
However, sensitivity analyses revealed that the probiotic was cost-effective in patients with frequent relapsing pouchitis — defined as two or more episodes per year.
In this subgroup, the ICER dropped below the willingness-to-pay threshold of $100,000 per QALY, and in some scenarios, the probiotic even became the dominant strategy, meaning it was both more effective and less costly than no prophylaxis, the researchers noted.
Current guidelines from AGA on managing pouchitis suggest using probiotics to prevent recurrent episodes of pouchitis with a caveat that those who experience infrequent episodes may choose to avoid secondary prevention strategies.
“Our findings supplement the guidelines by confirming that the eight-strain probiotics can be cost-effective in frequent relapsing not in infrequent relapsing pouchitis,” the authors wrote.
They also noted that the probiotic cost itself was the biggest driver of results, accounting for 95% of the total cost in the primary prevention model. According to their analysis, reducing its price by half could make it a cost-effective option more broadly.
They also noted that probiotic prophylaxis could be cost-effective for patients at higher-than-average risk, such as those with primary sclerosing cholangitis (PSC), who have 4.2 times higher odds of developing pouchitis than peers without PSC.
But they cautioned that “further research is warranted on the effectiveness of the eight-strain probiotic for primary prevention of pouchitis in patients with ulcerative colitis and IPAA and PSC.”
The study had no financial support. Syal reported receiving research support from Pfizer.
A version of this article appeared on Medscape.com.
, but its cost-effectiveness depends on relapse risk and may only be justified in patients who experience frequent relapses of pouchitis, a new analysis showed.
“Our findings highlight that while probiotic treatments can reduce the risk of this complication, their high costs limit their overall value for most patients,” lead author Gaurav Syal, MD, a gastroenterologist at UCLA Health, said in a statement.
“Our analysis can help guide shared decision-making between patients, clinicians, and payers to ensure resources are used where they can provide the most benefit,” Syal added.
The study was published online in Gastro Hep Advances.
Common Complication After Ulcerative Colitis Surgery
Pouchitis is a common complication in patients with ulcerative colitis who undergo restorative proctocolectomy with IPAA, with a cumulative incidence of around 48% at 2 years and 80% at 30 years.
Many patients who experience pouchitis have a single episode and respond well to short antibiotic courses. However, others develop recurrent or relapsing pouchitis, and 17% progress to a chronic form that can become dependent on antibiotics or refractory to antibiotics.
An eight-strain probiotic was shown to be effective in primary and secondary prevention of pouchitis in randomized, placebo-controlled trials.
Syal and colleagues sought to determine whether it’s worth the cost.
They constructed decision-tree models with Markov simulations to compare the risk for initial development and recurrence of pouchitis over a 2-year period between no prophylaxis and daily use of the eight-strain probiotic.
In the primary prophylaxis model, the cycle length was 2 weeks and pouchitis treatment sequence was ciprofloxacin, metronidazole and ciprofloxacin-tinidazole. In the secondary prophylaxis model, the cycle length was 4 weeks and pouchitis treatment sequence was initially the same as the primary prophylaxis model with the addition of vedolizumab and infliximab.
Costs were calculated from a US third-party payer perspective, using a willingness-to-pay threshold of $100,000 per quality-adjusted life year (QALY).
For primary prevention, the probiotic slightly increased QALYs compared with no probiotic (0.927 vs 0.918) but at a far higher cost ($2223 vs $299), resulting in an incremental cost-effectiveness ratio (ICER) of $236,076 per QALY — well above the accepted threshold.
In patients with infrequent relapses, probiotic use was slightly more effective than no use of probiotic (cumulative QALYs, 1.26 vs 1.24) but more expensive ($3370 vs $557), yielding an ICER of $153,011 per QALY — again above the accepted threshold.
However, sensitivity analyses revealed that the probiotic was cost-effective in patients with frequent relapsing pouchitis — defined as two or more episodes per year.
In this subgroup, the ICER dropped below the willingness-to-pay threshold of $100,000 per QALY, and in some scenarios, the probiotic even became the dominant strategy, meaning it was both more effective and less costly than no prophylaxis, the researchers noted.
Current guidelines from AGA on managing pouchitis suggest using probiotics to prevent recurrent episodes of pouchitis with a caveat that those who experience infrequent episodes may choose to avoid secondary prevention strategies.
“Our findings supplement the guidelines by confirming that the eight-strain probiotics can be cost-effective in frequent relapsing not in infrequent relapsing pouchitis,” the authors wrote.
They also noted that the probiotic cost itself was the biggest driver of results, accounting for 95% of the total cost in the primary prevention model. According to their analysis, reducing its price by half could make it a cost-effective option more broadly.
They also noted that probiotic prophylaxis could be cost-effective for patients at higher-than-average risk, such as those with primary sclerosing cholangitis (PSC), who have 4.2 times higher odds of developing pouchitis than peers without PSC.
But they cautioned that “further research is warranted on the effectiveness of the eight-strain probiotic for primary prevention of pouchitis in patients with ulcerative colitis and IPAA and PSC.”
The study had no financial support. Syal reported receiving research support from Pfizer.
A version of this article appeared on Medscape.com.
FROM GASTRO HEP ADVANCES
Bariatric Surgery May Lower Long-Term CKD Risk
, according to a population-based study in Denmark.
Writing in BMC Nephrology, researchers reported patients with bariatric surgery had an increased 1-year risk for AKI and 10-year risk for nephrolithiasis, alongside a decreased 10-year risk for CKD (stages G3-5) and KFRT, compared with matched patients diagnosed with overweight/obesity who did not undergo surgery.
A Closer Look
Using national registry data, the team identified all adults who underwent Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG) between January 1, 2006, and December 31, 2018. Each patient was age- and sex-matched (1:5) to patients with hospital-diagnosed overweight/obesity without bariatric surgery. Researchers also compared results against a population cohort matched solely by age and sex. Outcomes included cumulative risks for AKI, nephrolithiasis, CKD (G3-G5), and KFRT.
The cohort comprised 18,827 surgical patients (17,200 RYGB and 1627 SG) and 94,135 matched comparators. Median age was 41 years, 76% were women, and the median follow-up was 8.1 years. At baseline, the median estimated glomerular filtration rate (eGFR) was comparable (103 mL/min/1.73 m2) between both surgery and overweight/obesity control groups, as were A1c levels. There were fewer comorbidities in the population cohort matched only by age and sex than in the overweight/obesity comparison cohort.
Using multivariable Cox regression analyses, the researchers found the 1-year risk for AKI following bariatric surgery was 2.7%. At 10 years, risks were 3.5% for nephrolithiasis, 0.4% for CKD, and 0.2% for KFRT.
Adjusted hazard ratios (HRs) after bariatric surgery vs without bariatric surgery were higher for AKI (HR, 1.63) and nephrolithiasis (HR, 1.73) and lower for CKD (HR, 0.41) and KFRT (HR, 0.63). Results were consistent when compared against the population cohort.
By procedure, the 1-year AKI risk was 2.7% after RYGB and 2.4% after SG vs 2.5% in the overweight/obesity cohort and 1.1% in the population cohort. At 10 years, the risk for incident nephrolithiasis was 3.6% after RYGB and 1.2% after SG vs 2.4% and 1.3% in the overweight/obese and population cohorts, respectively. KFRT risk at 10 years was 0.2% after RYGB and 1.6% after SG vs 0.4% and 0.1% in the overweight/obesity and population cohorts, respectively.
“The increased short-term risk of AKI and nephrolithiasis was expected, given the physiological changes after bariatric surgery, but the long-term reduction in CKD and KFRT was both encouraging and clinically important,” said study investigator Christian Goul Sørensen, MD, Department of Clinical Epidemiology, Department of Clinical Medicine, Aarhus University and Aarhus University Hospital, Aarhus, Denmark. “It was also noteworthy that the results were consistent not only in the obesity-matched comparison cohort but also in the cohort matched solely on age and sex, which further strengthens the validity of our findings.”
RYGB and SG are known to help mitigate obesity-associated complications, such as hypertension, hyperlipidemia, and type 2 diabetes. Studies have suggested that there are improvements in eGFR after bariatric surgery. However, long-term evidence from routine clinical care has not been well studied. Furthermore, RYGB may lead to AKI due to a combination of preoperative, intraoperative, and postoperative factors.
“Obesity is a major driver of kidney disease, often in combination with comorbidities such as diabetes and hypertension,” Sorensen told GI & Hepatology News. “Patients and clinicians face complex decisions about surgery, and understanding both the short-term surgical risks and the long-term kidney benefits is crucial for informed counseling. As bariatric surgery becomes increasingly common worldwide, population-based evidence like this helps guide clinical practice and supports shared decision-making with patients.”
Consistent With Clinical Experience
Panduranga S. Rao, MD, professor of nephrology at the University of Michigan, Ann Arbor, Michigan, who was not involved in the study, called the results consistent with prior clinical experience. He highlighted the strong follow-up and detailed lab and comorbidity data, while noting that the decreasing use of RYGB may limit applicability going forward.
“However, one has to remain vigilant to the risk of nephrolithiasis in the patients who have undergone Roux-en-Y in the past,” he said.
The observation of decreasing risk for CKD with weight loss is particularly relevant, given the growing use of GLP-1s for weight loss, Rao added.
Srinivasan Beddhu, MD, professor of internal medicine and the scientific director of the Cardio-Renal & Metabolism Center at the University of Utah Health in Salt Lake City, said the large national cohort design and outcomes data offer further reassurance about the long-term kidney health effects of bariatric surgery.
“The message that the risks of AKI and nephrolithiasis are outweighed by the long-term kidney protective effects of bariatric surgery is important,” said Beddhu.
Alexander Chang, MD, associate professor and a practicing nephrologist at the Geisinger Health System in Danville, Pennsylvania, noted that the study provided more evidence about RYGB-associated kidney stone risk via fat malabsorption, which raises the levels of fatty acids that bind dietary calcium.
“Calcium normally precipitates with dietary oxalate, and thus, there can be an increase in urinary oxalate,” Chang explained. “There did not appear to be increased risk of nephrolithiasis with sleeve gastrectomy, consistent with other studies.
“This study emphasizes the importance of multidisciplinary care post-bariatric surgery to try to prevent complications such as kidney stones,” Chang added. “This can be tricky but requires trying different strategies to increase fluid intake and calcium citrate supplements with meals.”
The study was partly funded by a grant from the Novo Nordisk Foundation and the Independent Research Fund Denmark. One author reported receiving a speaking fee support from Novo Nordisk for conference attendance. The other authors declared no competing interests. Sørensen, Rao, Beddhu, and Chang had no financial disclosures.
A version of this article appeared on Medscape.com.
, according to a population-based study in Denmark.
Writing in BMC Nephrology, researchers reported patients with bariatric surgery had an increased 1-year risk for AKI and 10-year risk for nephrolithiasis, alongside a decreased 10-year risk for CKD (stages G3-5) and KFRT, compared with matched patients diagnosed with overweight/obesity who did not undergo surgery.
A Closer Look
Using national registry data, the team identified all adults who underwent Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG) between January 1, 2006, and December 31, 2018. Each patient was age- and sex-matched (1:5) to patients with hospital-diagnosed overweight/obesity without bariatric surgery. Researchers also compared results against a population cohort matched solely by age and sex. Outcomes included cumulative risks for AKI, nephrolithiasis, CKD (G3-G5), and KFRT.
The cohort comprised 18,827 surgical patients (17,200 RYGB and 1627 SG) and 94,135 matched comparators. Median age was 41 years, 76% were women, and the median follow-up was 8.1 years. At baseline, the median estimated glomerular filtration rate (eGFR) was comparable (103 mL/min/1.73 m2) between both surgery and overweight/obesity control groups, as were A1c levels. There were fewer comorbidities in the population cohort matched only by age and sex than in the overweight/obesity comparison cohort.
Using multivariable Cox regression analyses, the researchers found the 1-year risk for AKI following bariatric surgery was 2.7%. At 10 years, risks were 3.5% for nephrolithiasis, 0.4% for CKD, and 0.2% for KFRT.
Adjusted hazard ratios (HRs) after bariatric surgery vs without bariatric surgery were higher for AKI (HR, 1.63) and nephrolithiasis (HR, 1.73) and lower for CKD (HR, 0.41) and KFRT (HR, 0.63). Results were consistent when compared against the population cohort.
By procedure, the 1-year AKI risk was 2.7% after RYGB and 2.4% after SG vs 2.5% in the overweight/obesity cohort and 1.1% in the population cohort. At 10 years, the risk for incident nephrolithiasis was 3.6% after RYGB and 1.2% after SG vs 2.4% and 1.3% in the overweight/obese and population cohorts, respectively. KFRT risk at 10 years was 0.2% after RYGB and 1.6% after SG vs 0.4% and 0.1% in the overweight/obesity and population cohorts, respectively.
“The increased short-term risk of AKI and nephrolithiasis was expected, given the physiological changes after bariatric surgery, but the long-term reduction in CKD and KFRT was both encouraging and clinically important,” said study investigator Christian Goul Sørensen, MD, Department of Clinical Epidemiology, Department of Clinical Medicine, Aarhus University and Aarhus University Hospital, Aarhus, Denmark. “It was also noteworthy that the results were consistent not only in the obesity-matched comparison cohort but also in the cohort matched solely on age and sex, which further strengthens the validity of our findings.”
RYGB and SG are known to help mitigate obesity-associated complications, such as hypertension, hyperlipidemia, and type 2 diabetes. Studies have suggested that there are improvements in eGFR after bariatric surgery. However, long-term evidence from routine clinical care has not been well studied. Furthermore, RYGB may lead to AKI due to a combination of preoperative, intraoperative, and postoperative factors.
“Obesity is a major driver of kidney disease, often in combination with comorbidities such as diabetes and hypertension,” Sorensen told GI & Hepatology News. “Patients and clinicians face complex decisions about surgery, and understanding both the short-term surgical risks and the long-term kidney benefits is crucial for informed counseling. As bariatric surgery becomes increasingly common worldwide, population-based evidence like this helps guide clinical practice and supports shared decision-making with patients.”
Consistent With Clinical Experience
Panduranga S. Rao, MD, professor of nephrology at the University of Michigan, Ann Arbor, Michigan, who was not involved in the study, called the results consistent with prior clinical experience. He highlighted the strong follow-up and detailed lab and comorbidity data, while noting that the decreasing use of RYGB may limit applicability going forward.
“However, one has to remain vigilant to the risk of nephrolithiasis in the patients who have undergone Roux-en-Y in the past,” he said.
The observation of decreasing risk for CKD with weight loss is particularly relevant, given the growing use of GLP-1s for weight loss, Rao added.
Srinivasan Beddhu, MD, professor of internal medicine and the scientific director of the Cardio-Renal & Metabolism Center at the University of Utah Health in Salt Lake City, said the large national cohort design and outcomes data offer further reassurance about the long-term kidney health effects of bariatric surgery.
“The message that the risks of AKI and nephrolithiasis are outweighed by the long-term kidney protective effects of bariatric surgery is important,” said Beddhu.
Alexander Chang, MD, associate professor and a practicing nephrologist at the Geisinger Health System in Danville, Pennsylvania, noted that the study provided more evidence about RYGB-associated kidney stone risk via fat malabsorption, which raises the levels of fatty acids that bind dietary calcium.
“Calcium normally precipitates with dietary oxalate, and thus, there can be an increase in urinary oxalate,” Chang explained. “There did not appear to be increased risk of nephrolithiasis with sleeve gastrectomy, consistent with other studies.
“This study emphasizes the importance of multidisciplinary care post-bariatric surgery to try to prevent complications such as kidney stones,” Chang added. “This can be tricky but requires trying different strategies to increase fluid intake and calcium citrate supplements with meals.”
The study was partly funded by a grant from the Novo Nordisk Foundation and the Independent Research Fund Denmark. One author reported receiving a speaking fee support from Novo Nordisk for conference attendance. The other authors declared no competing interests. Sørensen, Rao, Beddhu, and Chang had no financial disclosures.
A version of this article appeared on Medscape.com.
, according to a population-based study in Denmark.
Writing in BMC Nephrology, researchers reported patients with bariatric surgery had an increased 1-year risk for AKI and 10-year risk for nephrolithiasis, alongside a decreased 10-year risk for CKD (stages G3-5) and KFRT, compared with matched patients diagnosed with overweight/obesity who did not undergo surgery.
A Closer Look
Using national registry data, the team identified all adults who underwent Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG) between January 1, 2006, and December 31, 2018. Each patient was age- and sex-matched (1:5) to patients with hospital-diagnosed overweight/obesity without bariatric surgery. Researchers also compared results against a population cohort matched solely by age and sex. Outcomes included cumulative risks for AKI, nephrolithiasis, CKD (G3-G5), and KFRT.
The cohort comprised 18,827 surgical patients (17,200 RYGB and 1627 SG) and 94,135 matched comparators. Median age was 41 years, 76% were women, and the median follow-up was 8.1 years. At baseline, the median estimated glomerular filtration rate (eGFR) was comparable (103 mL/min/1.73 m2) between both surgery and overweight/obesity control groups, as were A1c levels. There were fewer comorbidities in the population cohort matched only by age and sex than in the overweight/obesity comparison cohort.
Using multivariable Cox regression analyses, the researchers found the 1-year risk for AKI following bariatric surgery was 2.7%. At 10 years, risks were 3.5% for nephrolithiasis, 0.4% for CKD, and 0.2% for KFRT.
Adjusted hazard ratios (HRs) after bariatric surgery vs without bariatric surgery were higher for AKI (HR, 1.63) and nephrolithiasis (HR, 1.73) and lower for CKD (HR, 0.41) and KFRT (HR, 0.63). Results were consistent when compared against the population cohort.
By procedure, the 1-year AKI risk was 2.7% after RYGB and 2.4% after SG vs 2.5% in the overweight/obesity cohort and 1.1% in the population cohort. At 10 years, the risk for incident nephrolithiasis was 3.6% after RYGB and 1.2% after SG vs 2.4% and 1.3% in the overweight/obese and population cohorts, respectively. KFRT risk at 10 years was 0.2% after RYGB and 1.6% after SG vs 0.4% and 0.1% in the overweight/obesity and population cohorts, respectively.
“The increased short-term risk of AKI and nephrolithiasis was expected, given the physiological changes after bariatric surgery, but the long-term reduction in CKD and KFRT was both encouraging and clinically important,” said study investigator Christian Goul Sørensen, MD, Department of Clinical Epidemiology, Department of Clinical Medicine, Aarhus University and Aarhus University Hospital, Aarhus, Denmark. “It was also noteworthy that the results were consistent not only in the obesity-matched comparison cohort but also in the cohort matched solely on age and sex, which further strengthens the validity of our findings.”
RYGB and SG are known to help mitigate obesity-associated complications, such as hypertension, hyperlipidemia, and type 2 diabetes. Studies have suggested that there are improvements in eGFR after bariatric surgery. However, long-term evidence from routine clinical care has not been well studied. Furthermore, RYGB may lead to AKI due to a combination of preoperative, intraoperative, and postoperative factors.
“Obesity is a major driver of kidney disease, often in combination with comorbidities such as diabetes and hypertension,” Sorensen told GI & Hepatology News. “Patients and clinicians face complex decisions about surgery, and understanding both the short-term surgical risks and the long-term kidney benefits is crucial for informed counseling. As bariatric surgery becomes increasingly common worldwide, population-based evidence like this helps guide clinical practice and supports shared decision-making with patients.”
Consistent With Clinical Experience
Panduranga S. Rao, MD, professor of nephrology at the University of Michigan, Ann Arbor, Michigan, who was not involved in the study, called the results consistent with prior clinical experience. He highlighted the strong follow-up and detailed lab and comorbidity data, while noting that the decreasing use of RYGB may limit applicability going forward.
“However, one has to remain vigilant to the risk of nephrolithiasis in the patients who have undergone Roux-en-Y in the past,” he said.
The observation of decreasing risk for CKD with weight loss is particularly relevant, given the growing use of GLP-1s for weight loss, Rao added.
Srinivasan Beddhu, MD, professor of internal medicine and the scientific director of the Cardio-Renal & Metabolism Center at the University of Utah Health in Salt Lake City, said the large national cohort design and outcomes data offer further reassurance about the long-term kidney health effects of bariatric surgery.
“The message that the risks of AKI and nephrolithiasis are outweighed by the long-term kidney protective effects of bariatric surgery is important,” said Beddhu.
Alexander Chang, MD, associate professor and a practicing nephrologist at the Geisinger Health System in Danville, Pennsylvania, noted that the study provided more evidence about RYGB-associated kidney stone risk via fat malabsorption, which raises the levels of fatty acids that bind dietary calcium.
“Calcium normally precipitates with dietary oxalate, and thus, there can be an increase in urinary oxalate,” Chang explained. “There did not appear to be increased risk of nephrolithiasis with sleeve gastrectomy, consistent with other studies.
“This study emphasizes the importance of multidisciplinary care post-bariatric surgery to try to prevent complications such as kidney stones,” Chang added. “This can be tricky but requires trying different strategies to increase fluid intake and calcium citrate supplements with meals.”
The study was partly funded by a grant from the Novo Nordisk Foundation and the Independent Research Fund Denmark. One author reported receiving a speaking fee support from Novo Nordisk for conference attendance. The other authors declared no competing interests. Sørensen, Rao, Beddhu, and Chang had no financial disclosures.
A version of this article appeared on Medscape.com.
Getting Ahead of Gastrointestinal Cancer
Early-onset gastrointestinal (GI) cancers are climbing among those younger than 50 years, in the US and globally. Although colorectal cancer accounts for approximately half of such cases, rates are also increasing for gastric, esophageal, pancreatic, and several rarer GI malignancies.
Because most in this age group are not included in screening protocols and may present with vague symptoms, diagnosis and treatment is frequently delayed. According to experts in the field, counteracting this trend requires establishing a lower threshold for evaluation, attention to modifiable risk factors, and embracing emerging noninvasive diagnostic tools.
Diagnostic Dilemmas
“Colorectal cancer in particular is often diagnosed later in life,” said Nicholas DeVito, MD, assistant professor at Duke University Medical Center, Durham, North Carolina, and a specialist in GI malignancies. “When the patient is too young for routine screening colonoscopy (< 45 years), they aren’t screened at all, they do not have alarming symptoms, or their symptoms are overlooked.” Other increasingly common GI cancers in young people (esophageal, gastric, pancreatic) lack routine screening guidelines due to limited evidence, he added.
Symptoms such as nausea, weight loss, upset stomach, and abdominal pain are often nonspecific and have many other potential causes, so GI cancers may not be high on the list of possible diagnoses in patients younger than 50 years, said DeVito.
“Insurance coverage, socioeconomic status, appointment availability, and awareness of symptoms and screening methods are all barriers to diagnosis as well, which affect the diagnostic timeline of many cancers,” he added.“While there are multiple factors that contribute to a cancer diagnosis, it seems that obesity, a Western diet, a sedentary lifestyle are all major contributors to the rise in early GI cancers,” DeVito told GI & Hepatology News. “There is no blame or judgement to go around as cancer can happen to anyone at any time, with none of these factors present,” he emphasized.
When counseling patients about GI cancer risk, DeVito recommends keeping advice simple and specific. In general, they should restrict red meat to once a week, emphasize fresh fruits and vegetables, cap alcohol to ≤ 1 serving per day, and limit ultraprocessed foods (e.g., packaged snacks, preprepared meals, and sugary beverages).
Exercise is another pillar. “Find an activity you enjoy and work toward 30 minutes of aerobic exercise three times a week,” he advised. He also encourages finding opportunities to incorporate physical activity in daily lives, such as using a standing desk at work, while keeping patients’ socioeconomic constraints in mind.
Evidence around GI cancer prevention interventions is still evolving. However, a randomized phase 3 trial presented at American Society of Clinical Oncology’s 2025 meeting found significant improvement in disease-free survival among adults with resected stage III or high-risk stage II colon cancer (median age, 61 years) who reported higher intake of anti-inflammatory foods and greater exercise than a comparator group.
“In general, clinicians should be aware of the risk factors, make referrals to physical therapy, weight-loss specialists, endocrinologists, and nutritionists when appropriate, and be consistent and clear with patients about recommendations and what’s achievable,” DeVito said. “Meeting patients where they are can help make incremental progress, as these interventions take time and patience, and we should be understanding of that.”
Identifying at-risk younger adults goes beyond discussing family history and obesity to include diet, exercise, and daily lifestyle, he added.
“Symptoms of potential GI cancer need to be taken seriously in all patients, and there should be a lower threshold in 2025 to get a colonoscopy, endoscopy, or CT scan than in previous years given all that we know today. We then need to establish through clinical studies who needs screening tests and who doesn’t, and what interventions work best to reduce risk.”
Vigilance in the Absence of Screening
“Most GI cancers, unfortunately, can grow a fair amount before symptoms arise, so many patients present with symptoms only when a tumor has grown enough to affect organ function,” said Miguel Burch, MD, chief of minimally invasive and GI surgery at Cedars-Sinai Medical Center, Los Angeles.
Early screening improves outcomes in gastric cancer, Burch noted, and survival benefits are reflected in several East Asian countries that offer gastric cancer screening starting at age 40. In one study from Korea, a single upper endoscopy was associated with an approximate 40% reduction in gastric cancer mortality compared with no screening.
, Burch emphasized. The impact is wide-ranging, contributing to increased morbidity and mortality in younger adults often in their most productive years, leading to lost wages and emotional strains upon patients and their families.Routine endoscopic or imaging screening is not typically performed in the US, and newer blood-based tests such as circulating tumor DNA are not yet sensitive enough to reliably detect very early-stage disease. Nonetheless, there is evidence that noninvasive biomarkers could soon help expand GI cancer screening.
In a study published in JAMA Surgery, Sui and colleagues tested a 10-microRNA signature assay (Destinex) for early detection of gastric cancer and reported robust identification rates above 95%.
“In recent years, the liquid biopsy has gained momentum with the hope of augmenting cancer detection from peripheral blood, even indicating potential as a screening test for healthy populations,” wrote Max R. Coffey, MD, and Vivian E. Strong, MD, both of the Memorial Sloan Kettering Cancer Center in New York City, in an accompanying editorial.
“Early detection is absolutely critical; when gastric cancer is found early, outcomes are dramatically better,” Strong told GI & Hepatology News. Subtle symptoms — reflux, persistent GI discomfort, or unexplained weight loss — should never be ignored, she added.
Early detection should also focus on additional risk factors such as prior Helicobacter pylori infection, smoking, and family history.
“Anyone with a personal or family history of H pylori should have very careful follow-up, and if one household member tests positive, all should be checked,” Strong said. “Just as importantly, if one or more family members have had stomach cancer, that should be discussed with a healthcare provider, as it may warrant higher-level surveillance and genetic testing.”
Individuals concerned about increased risk for GI cancer should proactively ask their doctors whether they might benefit from testing or surveillance, Strong added.
“Lifestyle changes, timely medical evaluation, and tailored surveillance all play a vital role in prevention.”
DeVito disclosed clinical trial funding from the Gateway foundation, Xilio, Phanes, Astellas, GSK, as well as consulting fees/advisory board participation for Guardant, Agenus, and Xilio. Strong disclosed speaking honoraria for Merck and Astra Zeneca.
The study by Sui and colleagues was supported by the National Cancer Institute, National Institutes of Health, as well as by a grant from the American Gastroenterological Association Robert & Sally Funderburg Research Award in Gastric Cancer, and the Stupid Strong Foundation.
Burch had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
Early-onset gastrointestinal (GI) cancers are climbing among those younger than 50 years, in the US and globally. Although colorectal cancer accounts for approximately half of such cases, rates are also increasing for gastric, esophageal, pancreatic, and several rarer GI malignancies.
Because most in this age group are not included in screening protocols and may present with vague symptoms, diagnosis and treatment is frequently delayed. According to experts in the field, counteracting this trend requires establishing a lower threshold for evaluation, attention to modifiable risk factors, and embracing emerging noninvasive diagnostic tools.
Diagnostic Dilemmas
“Colorectal cancer in particular is often diagnosed later in life,” said Nicholas DeVito, MD, assistant professor at Duke University Medical Center, Durham, North Carolina, and a specialist in GI malignancies. “When the patient is too young for routine screening colonoscopy (< 45 years), they aren’t screened at all, they do not have alarming symptoms, or their symptoms are overlooked.” Other increasingly common GI cancers in young people (esophageal, gastric, pancreatic) lack routine screening guidelines due to limited evidence, he added.
Symptoms such as nausea, weight loss, upset stomach, and abdominal pain are often nonspecific and have many other potential causes, so GI cancers may not be high on the list of possible diagnoses in patients younger than 50 years, said DeVito.
“Insurance coverage, socioeconomic status, appointment availability, and awareness of symptoms and screening methods are all barriers to diagnosis as well, which affect the diagnostic timeline of many cancers,” he added.“While there are multiple factors that contribute to a cancer diagnosis, it seems that obesity, a Western diet, a sedentary lifestyle are all major contributors to the rise in early GI cancers,” DeVito told GI & Hepatology News. “There is no blame or judgement to go around as cancer can happen to anyone at any time, with none of these factors present,” he emphasized.
When counseling patients about GI cancer risk, DeVito recommends keeping advice simple and specific. In general, they should restrict red meat to once a week, emphasize fresh fruits and vegetables, cap alcohol to ≤ 1 serving per day, and limit ultraprocessed foods (e.g., packaged snacks, preprepared meals, and sugary beverages).
Exercise is another pillar. “Find an activity you enjoy and work toward 30 minutes of aerobic exercise three times a week,” he advised. He also encourages finding opportunities to incorporate physical activity in daily lives, such as using a standing desk at work, while keeping patients’ socioeconomic constraints in mind.
Evidence around GI cancer prevention interventions is still evolving. However, a randomized phase 3 trial presented at American Society of Clinical Oncology’s 2025 meeting found significant improvement in disease-free survival among adults with resected stage III or high-risk stage II colon cancer (median age, 61 years) who reported higher intake of anti-inflammatory foods and greater exercise than a comparator group.
“In general, clinicians should be aware of the risk factors, make referrals to physical therapy, weight-loss specialists, endocrinologists, and nutritionists when appropriate, and be consistent and clear with patients about recommendations and what’s achievable,” DeVito said. “Meeting patients where they are can help make incremental progress, as these interventions take time and patience, and we should be understanding of that.”
Identifying at-risk younger adults goes beyond discussing family history and obesity to include diet, exercise, and daily lifestyle, he added.
“Symptoms of potential GI cancer need to be taken seriously in all patients, and there should be a lower threshold in 2025 to get a colonoscopy, endoscopy, or CT scan than in previous years given all that we know today. We then need to establish through clinical studies who needs screening tests and who doesn’t, and what interventions work best to reduce risk.”
Vigilance in the Absence of Screening
“Most GI cancers, unfortunately, can grow a fair amount before symptoms arise, so many patients present with symptoms only when a tumor has grown enough to affect organ function,” said Miguel Burch, MD, chief of minimally invasive and GI surgery at Cedars-Sinai Medical Center, Los Angeles.
Early screening improves outcomes in gastric cancer, Burch noted, and survival benefits are reflected in several East Asian countries that offer gastric cancer screening starting at age 40. In one study from Korea, a single upper endoscopy was associated with an approximate 40% reduction in gastric cancer mortality compared with no screening.
, Burch emphasized. The impact is wide-ranging, contributing to increased morbidity and mortality in younger adults often in their most productive years, leading to lost wages and emotional strains upon patients and their families.Routine endoscopic or imaging screening is not typically performed in the US, and newer blood-based tests such as circulating tumor DNA are not yet sensitive enough to reliably detect very early-stage disease. Nonetheless, there is evidence that noninvasive biomarkers could soon help expand GI cancer screening.
In a study published in JAMA Surgery, Sui and colleagues tested a 10-microRNA signature assay (Destinex) for early detection of gastric cancer and reported robust identification rates above 95%.
“In recent years, the liquid biopsy has gained momentum with the hope of augmenting cancer detection from peripheral blood, even indicating potential as a screening test for healthy populations,” wrote Max R. Coffey, MD, and Vivian E. Strong, MD, both of the Memorial Sloan Kettering Cancer Center in New York City, in an accompanying editorial.
“Early detection is absolutely critical; when gastric cancer is found early, outcomes are dramatically better,” Strong told GI & Hepatology News. Subtle symptoms — reflux, persistent GI discomfort, or unexplained weight loss — should never be ignored, she added.
Early detection should also focus on additional risk factors such as prior Helicobacter pylori infection, smoking, and family history.
“Anyone with a personal or family history of H pylori should have very careful follow-up, and if one household member tests positive, all should be checked,” Strong said. “Just as importantly, if one or more family members have had stomach cancer, that should be discussed with a healthcare provider, as it may warrant higher-level surveillance and genetic testing.”
Individuals concerned about increased risk for GI cancer should proactively ask their doctors whether they might benefit from testing or surveillance, Strong added.
“Lifestyle changes, timely medical evaluation, and tailored surveillance all play a vital role in prevention.”
DeVito disclosed clinical trial funding from the Gateway foundation, Xilio, Phanes, Astellas, GSK, as well as consulting fees/advisory board participation for Guardant, Agenus, and Xilio. Strong disclosed speaking honoraria for Merck and Astra Zeneca.
The study by Sui and colleagues was supported by the National Cancer Institute, National Institutes of Health, as well as by a grant from the American Gastroenterological Association Robert & Sally Funderburg Research Award in Gastric Cancer, and the Stupid Strong Foundation.
Burch had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
Early-onset gastrointestinal (GI) cancers are climbing among those younger than 50 years, in the US and globally. Although colorectal cancer accounts for approximately half of such cases, rates are also increasing for gastric, esophageal, pancreatic, and several rarer GI malignancies.
Because most in this age group are not included in screening protocols and may present with vague symptoms, diagnosis and treatment is frequently delayed. According to experts in the field, counteracting this trend requires establishing a lower threshold for evaluation, attention to modifiable risk factors, and embracing emerging noninvasive diagnostic tools.
Diagnostic Dilemmas
“Colorectal cancer in particular is often diagnosed later in life,” said Nicholas DeVito, MD, assistant professor at Duke University Medical Center, Durham, North Carolina, and a specialist in GI malignancies. “When the patient is too young for routine screening colonoscopy (< 45 years), they aren’t screened at all, they do not have alarming symptoms, or their symptoms are overlooked.” Other increasingly common GI cancers in young people (esophageal, gastric, pancreatic) lack routine screening guidelines due to limited evidence, he added.
Symptoms such as nausea, weight loss, upset stomach, and abdominal pain are often nonspecific and have many other potential causes, so GI cancers may not be high on the list of possible diagnoses in patients younger than 50 years, said DeVito.
“Insurance coverage, socioeconomic status, appointment availability, and awareness of symptoms and screening methods are all barriers to diagnosis as well, which affect the diagnostic timeline of many cancers,” he added.“While there are multiple factors that contribute to a cancer diagnosis, it seems that obesity, a Western diet, a sedentary lifestyle are all major contributors to the rise in early GI cancers,” DeVito told GI & Hepatology News. “There is no blame or judgement to go around as cancer can happen to anyone at any time, with none of these factors present,” he emphasized.
When counseling patients about GI cancer risk, DeVito recommends keeping advice simple and specific. In general, they should restrict red meat to once a week, emphasize fresh fruits and vegetables, cap alcohol to ≤ 1 serving per day, and limit ultraprocessed foods (e.g., packaged snacks, preprepared meals, and sugary beverages).
Exercise is another pillar. “Find an activity you enjoy and work toward 30 minutes of aerobic exercise three times a week,” he advised. He also encourages finding opportunities to incorporate physical activity in daily lives, such as using a standing desk at work, while keeping patients’ socioeconomic constraints in mind.
Evidence around GI cancer prevention interventions is still evolving. However, a randomized phase 3 trial presented at American Society of Clinical Oncology’s 2025 meeting found significant improvement in disease-free survival among adults with resected stage III or high-risk stage II colon cancer (median age, 61 years) who reported higher intake of anti-inflammatory foods and greater exercise than a comparator group.
“In general, clinicians should be aware of the risk factors, make referrals to physical therapy, weight-loss specialists, endocrinologists, and nutritionists when appropriate, and be consistent and clear with patients about recommendations and what’s achievable,” DeVito said. “Meeting patients where they are can help make incremental progress, as these interventions take time and patience, and we should be understanding of that.”
Identifying at-risk younger adults goes beyond discussing family history and obesity to include diet, exercise, and daily lifestyle, he added.
“Symptoms of potential GI cancer need to be taken seriously in all patients, and there should be a lower threshold in 2025 to get a colonoscopy, endoscopy, or CT scan than in previous years given all that we know today. We then need to establish through clinical studies who needs screening tests and who doesn’t, and what interventions work best to reduce risk.”
Vigilance in the Absence of Screening
“Most GI cancers, unfortunately, can grow a fair amount before symptoms arise, so many patients present with symptoms only when a tumor has grown enough to affect organ function,” said Miguel Burch, MD, chief of minimally invasive and GI surgery at Cedars-Sinai Medical Center, Los Angeles.
Early screening improves outcomes in gastric cancer, Burch noted, and survival benefits are reflected in several East Asian countries that offer gastric cancer screening starting at age 40. In one study from Korea, a single upper endoscopy was associated with an approximate 40% reduction in gastric cancer mortality compared with no screening.
, Burch emphasized. The impact is wide-ranging, contributing to increased morbidity and mortality in younger adults often in their most productive years, leading to lost wages and emotional strains upon patients and their families.Routine endoscopic or imaging screening is not typically performed in the US, and newer blood-based tests such as circulating tumor DNA are not yet sensitive enough to reliably detect very early-stage disease. Nonetheless, there is evidence that noninvasive biomarkers could soon help expand GI cancer screening.
In a study published in JAMA Surgery, Sui and colleagues tested a 10-microRNA signature assay (Destinex) for early detection of gastric cancer and reported robust identification rates above 95%.
“In recent years, the liquid biopsy has gained momentum with the hope of augmenting cancer detection from peripheral blood, even indicating potential as a screening test for healthy populations,” wrote Max R. Coffey, MD, and Vivian E. Strong, MD, both of the Memorial Sloan Kettering Cancer Center in New York City, in an accompanying editorial.
“Early detection is absolutely critical; when gastric cancer is found early, outcomes are dramatically better,” Strong told GI & Hepatology News. Subtle symptoms — reflux, persistent GI discomfort, or unexplained weight loss — should never be ignored, she added.
Early detection should also focus on additional risk factors such as prior Helicobacter pylori infection, smoking, and family history.
“Anyone with a personal or family history of H pylori should have very careful follow-up, and if one household member tests positive, all should be checked,” Strong said. “Just as importantly, if one or more family members have had stomach cancer, that should be discussed with a healthcare provider, as it may warrant higher-level surveillance and genetic testing.”
Individuals concerned about increased risk for GI cancer should proactively ask their doctors whether they might benefit from testing or surveillance, Strong added.
“Lifestyle changes, timely medical evaluation, and tailored surveillance all play a vital role in prevention.”
DeVito disclosed clinical trial funding from the Gateway foundation, Xilio, Phanes, Astellas, GSK, as well as consulting fees/advisory board participation for Guardant, Agenus, and Xilio. Strong disclosed speaking honoraria for Merck and Astra Zeneca.
The study by Sui and colleagues was supported by the National Cancer Institute, National Institutes of Health, as well as by a grant from the American Gastroenterological Association Robert & Sally Funderburg Research Award in Gastric Cancer, and the Stupid Strong Foundation.
Burch had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
Is AI Use Causing Endoscopists to Lose Their Skills?
, a large observational study suggested.
“The extent and consistency of the adenoma detection rate (ADR) drop after long-term AI use were not expected,” study authors Krzysztof Budzyń, MD, and Marcin Romańczyk, MD, of the Academy of Silesia, Katowice, Poland, told GI & Hepatology News. “We thought there might be a small effect, but the 6% absolute decrease — observed in several centers and among most endoscopists — points to a genuine change in behavior. This was especially notable because all participants were very experienced, with more than 2000 colonoscopies each.”
Another unexpected result, they said, “was that the decrease was stronger in centers with higher starting ADRs and in certain patient groups, such as women under 60. We had assumed experienced clinicians would be less affected, but our results show that even highly skilled practitioners can be influenced.”
The study was published online in The Lancet Gastroenterology & Hepatology.
ADR Reduced After AI Use
To assess how endoscopists who used AI regularly performed colonoscopy when AI was not in use, researchers conducted a retrospective, observational study at four endoscopy centers in Poland taking part in the ACCEPT trial.
These centers introduced AI tools for polyp detection at the end of 2021, after which colonoscopies were randomly assigned to be done with or without AI assistance.
The researchers assessed colonoscopy quality by comparing two different phases: 3 months before and 3 months after AI implementation. All diagnostic colonoscopies were included, except for those involving intensive anticoagulant use, pregnancy, or a history of colorectal resection or inflammatory bowel disease.
The primary outcome was the change in the ADR of standard, non-AI-assisted colonoscopy before and after AI exposure.
Between September 2021 and March 2022, a total of 2177 colonoscopies were conducted, including 1443 without AI use and 734 with AI. The current analysis focused on the 795 patients who underwent non-AI-assisted colonoscopy before the introduction of AI and the 648 who underwent non-AI-assisted colonoscopy after.
Participants’ median age was 61 years, and 59% were women. The colonoscopies were performed by 19 experienced endoscopists who had conducted over 2000 colonoscopies each.
The ADR of standard colonoscopy decreased significantly from 28.4% (226 of 795) before the introduction of AI to 22.4% (145 of 648) after, corresponding to a 20% relative and 6% absolute reduction in the ADR.
The ADR for AI-assisted colonoscopies was 25.3% (186 of 734).
The number of adenomas per colonoscopy (APC) in patients with at least one adenoma detected did not change significantly between the groups before and after AI exposure, with a mean of 1.91 before vs 1.92 after. Similarly, the number of mean advanced APC was comparable between the two periods (0.062 vs 0.063).
The mean advanced APC detection on standard colonoscopy in patients with at least one adenoma detected was 0.22 before AI exposure and 0.28 after AI exposure.
Colorectal cancers were detected in 6 (0.8%) of 795 colonoscopies before AI exposure and in 8 (1.2%) of 648 after AI exposure.
In multivariable logistic regression analysis, exposure to AI (odds ratio [OR], 0.69), patient’s male sex (OR, 1.78), and patient age at least 60 years (OR, 3.60) were independent factors significantly associated with ADR.
In all centers, the ADR for standard, non-AI-assisted colonoscopy was reduced after AI exposure, although the magnitude of ADR reduction varied greatly between centers, according to the authors.
“Clinicians should be aware that while AI can boost detection rates, prolonged reliance may subtly affect their performance when the technology is not available,” Budzyń and Romańczyk said. “This does not mean AI should be avoided — rather, it highlights the need for conscious engagement with the task, even when AI is assisting. Monitoring one’s own detection rates in both AI-assisted and non-AI-assisted procedures can help identify changes early.”
“Endoscopists should view AI as a collaborative partner, not a replacement for their vigilance and judgment,” they concluded. “Integrating AI effectively means using it to complement, not substitute, core observational and diagnostic skills. In short, enjoy the benefits of AI, but keep your skills sharp — your patients depend on both.”
Omer Ahmed, MD, of University College London, London, England, gives a similar message in a related editorial. The study “compels us to carefully consider the effect of AI integration into routine endoscopic practice,” he wrote. “Although AI continues to offer great promise to enhance clinical outcomes, we must also safeguard against the quiet erosion of fundamental skills required for high-quality endoscopy.”
‘Certainly a Signal’
Commenting on the study for GI & Hepatology News, Rajiv Bhuta, MD, assistant professor of clinical gastroenterology and hepatology at Temple University and a gastroenterologist at Temple University Hospital, both in Philadelphia, said, “On the face of it, these findings would seem to correlate with all our lived experiences as humans. Any skill or task that we give to a machine will inherently ‘de-skill’ or weaken our ability to perform it.”
“The only way to miss a polyp is either due to lack of attention/recognition of a polyp in the field of view or a lack of fold exposure and cleansing,” said Bhuta, who was not involved in the study. “For AI to specifically de-skill polyp detection, it would mean the AI is conditioning physicians to pay less active attention during the procedure, similar to the way a driver may pay less attention in a car that has self-driving capabilities.”
That said, he noted that this is a small retrospective observational study with a short timeframe and an average of fewer than 100 colonoscopies per physician.
“My own ADR may vary by 8% or more by random chance in such a small dataset,” he said. “It’s hard to draw any real conclusions, but it is certainly a signal.”
The issue of de-skilling goes beyond gastroenterology and medicine, Bhuta noted. “We have invented millions of machines that have ‘de-skilled’ us in thousands of small ways, and mostly, we have benefited as a society. However, we’ve never had a machine that can de-skill our attention, our creativity, and our reason.”
“The question is not whether AI will de-skill us but when, where, and how do we set the boundaries of what we want a machine to do for us,” he said. “What is lost and what is gained by AI taking over these roles, and is that an acceptable trade-off?”
The study was funded by the European Commission and the Japan Society for the Promotion of Science. Budzyń, Romańczyk, and Bhuta declared having no competing interests. Ahmed declared receiving medical consultancy fees from Olympus, Odin Vision, Medtronic, and Norgine.
A version of this article appeared on Medscape.com.
, a large observational study suggested.
“The extent and consistency of the adenoma detection rate (ADR) drop after long-term AI use were not expected,” study authors Krzysztof Budzyń, MD, and Marcin Romańczyk, MD, of the Academy of Silesia, Katowice, Poland, told GI & Hepatology News. “We thought there might be a small effect, but the 6% absolute decrease — observed in several centers and among most endoscopists — points to a genuine change in behavior. This was especially notable because all participants were very experienced, with more than 2000 colonoscopies each.”
Another unexpected result, they said, “was that the decrease was stronger in centers with higher starting ADRs and in certain patient groups, such as women under 60. We had assumed experienced clinicians would be less affected, but our results show that even highly skilled practitioners can be influenced.”
The study was published online in The Lancet Gastroenterology & Hepatology.
ADR Reduced After AI Use
To assess how endoscopists who used AI regularly performed colonoscopy when AI was not in use, researchers conducted a retrospective, observational study at four endoscopy centers in Poland taking part in the ACCEPT trial.
These centers introduced AI tools for polyp detection at the end of 2021, after which colonoscopies were randomly assigned to be done with or without AI assistance.
The researchers assessed colonoscopy quality by comparing two different phases: 3 months before and 3 months after AI implementation. All diagnostic colonoscopies were included, except for those involving intensive anticoagulant use, pregnancy, or a history of colorectal resection or inflammatory bowel disease.
The primary outcome was the change in the ADR of standard, non-AI-assisted colonoscopy before and after AI exposure.
Between September 2021 and March 2022, a total of 2177 colonoscopies were conducted, including 1443 without AI use and 734 with AI. The current analysis focused on the 795 patients who underwent non-AI-assisted colonoscopy before the introduction of AI and the 648 who underwent non-AI-assisted colonoscopy after.
Participants’ median age was 61 years, and 59% were women. The colonoscopies were performed by 19 experienced endoscopists who had conducted over 2000 colonoscopies each.
The ADR of standard colonoscopy decreased significantly from 28.4% (226 of 795) before the introduction of AI to 22.4% (145 of 648) after, corresponding to a 20% relative and 6% absolute reduction in the ADR.
The ADR for AI-assisted colonoscopies was 25.3% (186 of 734).
The number of adenomas per colonoscopy (APC) in patients with at least one adenoma detected did not change significantly between the groups before and after AI exposure, with a mean of 1.91 before vs 1.92 after. Similarly, the number of mean advanced APC was comparable between the two periods (0.062 vs 0.063).
The mean advanced APC detection on standard colonoscopy in patients with at least one adenoma detected was 0.22 before AI exposure and 0.28 after AI exposure.
Colorectal cancers were detected in 6 (0.8%) of 795 colonoscopies before AI exposure and in 8 (1.2%) of 648 after AI exposure.
In multivariable logistic regression analysis, exposure to AI (odds ratio [OR], 0.69), patient’s male sex (OR, 1.78), and patient age at least 60 years (OR, 3.60) were independent factors significantly associated with ADR.
In all centers, the ADR for standard, non-AI-assisted colonoscopy was reduced after AI exposure, although the magnitude of ADR reduction varied greatly between centers, according to the authors.
“Clinicians should be aware that while AI can boost detection rates, prolonged reliance may subtly affect their performance when the technology is not available,” Budzyń and Romańczyk said. “This does not mean AI should be avoided — rather, it highlights the need for conscious engagement with the task, even when AI is assisting. Monitoring one’s own detection rates in both AI-assisted and non-AI-assisted procedures can help identify changes early.”
“Endoscopists should view AI as a collaborative partner, not a replacement for their vigilance and judgment,” they concluded. “Integrating AI effectively means using it to complement, not substitute, core observational and diagnostic skills. In short, enjoy the benefits of AI, but keep your skills sharp — your patients depend on both.”
Omer Ahmed, MD, of University College London, London, England, gives a similar message in a related editorial. The study “compels us to carefully consider the effect of AI integration into routine endoscopic practice,” he wrote. “Although AI continues to offer great promise to enhance clinical outcomes, we must also safeguard against the quiet erosion of fundamental skills required for high-quality endoscopy.”
‘Certainly a Signal’
Commenting on the study for GI & Hepatology News, Rajiv Bhuta, MD, assistant professor of clinical gastroenterology and hepatology at Temple University and a gastroenterologist at Temple University Hospital, both in Philadelphia, said, “On the face of it, these findings would seem to correlate with all our lived experiences as humans. Any skill or task that we give to a machine will inherently ‘de-skill’ or weaken our ability to perform it.”
“The only way to miss a polyp is either due to lack of attention/recognition of a polyp in the field of view or a lack of fold exposure and cleansing,” said Bhuta, who was not involved in the study. “For AI to specifically de-skill polyp detection, it would mean the AI is conditioning physicians to pay less active attention during the procedure, similar to the way a driver may pay less attention in a car that has self-driving capabilities.”
That said, he noted that this is a small retrospective observational study with a short timeframe and an average of fewer than 100 colonoscopies per physician.
“My own ADR may vary by 8% or more by random chance in such a small dataset,” he said. “It’s hard to draw any real conclusions, but it is certainly a signal.”
The issue of de-skilling goes beyond gastroenterology and medicine, Bhuta noted. “We have invented millions of machines that have ‘de-skilled’ us in thousands of small ways, and mostly, we have benefited as a society. However, we’ve never had a machine that can de-skill our attention, our creativity, and our reason.”
“The question is not whether AI will de-skill us but when, where, and how do we set the boundaries of what we want a machine to do for us,” he said. “What is lost and what is gained by AI taking over these roles, and is that an acceptable trade-off?”
The study was funded by the European Commission and the Japan Society for the Promotion of Science. Budzyń, Romańczyk, and Bhuta declared having no competing interests. Ahmed declared receiving medical consultancy fees from Olympus, Odin Vision, Medtronic, and Norgine.
A version of this article appeared on Medscape.com.
, a large observational study suggested.
“The extent and consistency of the adenoma detection rate (ADR) drop after long-term AI use were not expected,” study authors Krzysztof Budzyń, MD, and Marcin Romańczyk, MD, of the Academy of Silesia, Katowice, Poland, told GI & Hepatology News. “We thought there might be a small effect, but the 6% absolute decrease — observed in several centers and among most endoscopists — points to a genuine change in behavior. This was especially notable because all participants were very experienced, with more than 2000 colonoscopies each.”
Another unexpected result, they said, “was that the decrease was stronger in centers with higher starting ADRs and in certain patient groups, such as women under 60. We had assumed experienced clinicians would be less affected, but our results show that even highly skilled practitioners can be influenced.”
The study was published online in The Lancet Gastroenterology & Hepatology.
ADR Reduced After AI Use
To assess how endoscopists who used AI regularly performed colonoscopy when AI was not in use, researchers conducted a retrospective, observational study at four endoscopy centers in Poland taking part in the ACCEPT trial.
These centers introduced AI tools for polyp detection at the end of 2021, after which colonoscopies were randomly assigned to be done with or without AI assistance.
The researchers assessed colonoscopy quality by comparing two different phases: 3 months before and 3 months after AI implementation. All diagnostic colonoscopies were included, except for those involving intensive anticoagulant use, pregnancy, or a history of colorectal resection or inflammatory bowel disease.
The primary outcome was the change in the ADR of standard, non-AI-assisted colonoscopy before and after AI exposure.
Between September 2021 and March 2022, a total of 2177 colonoscopies were conducted, including 1443 without AI use and 734 with AI. The current analysis focused on the 795 patients who underwent non-AI-assisted colonoscopy before the introduction of AI and the 648 who underwent non-AI-assisted colonoscopy after.
Participants’ median age was 61 years, and 59% were women. The colonoscopies were performed by 19 experienced endoscopists who had conducted over 2000 colonoscopies each.
The ADR of standard colonoscopy decreased significantly from 28.4% (226 of 795) before the introduction of AI to 22.4% (145 of 648) after, corresponding to a 20% relative and 6% absolute reduction in the ADR.
The ADR for AI-assisted colonoscopies was 25.3% (186 of 734).
The number of adenomas per colonoscopy (APC) in patients with at least one adenoma detected did not change significantly between the groups before and after AI exposure, with a mean of 1.91 before vs 1.92 after. Similarly, the number of mean advanced APC was comparable between the two periods (0.062 vs 0.063).
The mean advanced APC detection on standard colonoscopy in patients with at least one adenoma detected was 0.22 before AI exposure and 0.28 after AI exposure.
Colorectal cancers were detected in 6 (0.8%) of 795 colonoscopies before AI exposure and in 8 (1.2%) of 648 after AI exposure.
In multivariable logistic regression analysis, exposure to AI (odds ratio [OR], 0.69), patient’s male sex (OR, 1.78), and patient age at least 60 years (OR, 3.60) were independent factors significantly associated with ADR.
In all centers, the ADR for standard, non-AI-assisted colonoscopy was reduced after AI exposure, although the magnitude of ADR reduction varied greatly between centers, according to the authors.
“Clinicians should be aware that while AI can boost detection rates, prolonged reliance may subtly affect their performance when the technology is not available,” Budzyń and Romańczyk said. “This does not mean AI should be avoided — rather, it highlights the need for conscious engagement with the task, even when AI is assisting. Monitoring one’s own detection rates in both AI-assisted and non-AI-assisted procedures can help identify changes early.”
“Endoscopists should view AI as a collaborative partner, not a replacement for their vigilance and judgment,” they concluded. “Integrating AI effectively means using it to complement, not substitute, core observational and diagnostic skills. In short, enjoy the benefits of AI, but keep your skills sharp — your patients depend on both.”
Omer Ahmed, MD, of University College London, London, England, gives a similar message in a related editorial. The study “compels us to carefully consider the effect of AI integration into routine endoscopic practice,” he wrote. “Although AI continues to offer great promise to enhance clinical outcomes, we must also safeguard against the quiet erosion of fundamental skills required for high-quality endoscopy.”
‘Certainly a Signal’
Commenting on the study for GI & Hepatology News, Rajiv Bhuta, MD, assistant professor of clinical gastroenterology and hepatology at Temple University and a gastroenterologist at Temple University Hospital, both in Philadelphia, said, “On the face of it, these findings would seem to correlate with all our lived experiences as humans. Any skill or task that we give to a machine will inherently ‘de-skill’ or weaken our ability to perform it.”
“The only way to miss a polyp is either due to lack of attention/recognition of a polyp in the field of view or a lack of fold exposure and cleansing,” said Bhuta, who was not involved in the study. “For AI to specifically de-skill polyp detection, it would mean the AI is conditioning physicians to pay less active attention during the procedure, similar to the way a driver may pay less attention in a car that has self-driving capabilities.”
That said, he noted that this is a small retrospective observational study with a short timeframe and an average of fewer than 100 colonoscopies per physician.
“My own ADR may vary by 8% or more by random chance in such a small dataset,” he said. “It’s hard to draw any real conclusions, but it is certainly a signal.”
The issue of de-skilling goes beyond gastroenterology and medicine, Bhuta noted. “We have invented millions of machines that have ‘de-skilled’ us in thousands of small ways, and mostly, we have benefited as a society. However, we’ve never had a machine that can de-skill our attention, our creativity, and our reason.”
“The question is not whether AI will de-skill us but when, where, and how do we set the boundaries of what we want a machine to do for us,” he said. “What is lost and what is gained by AI taking over these roles, and is that an acceptable trade-off?”
The study was funded by the European Commission and the Japan Society for the Promotion of Science. Budzyń, Romańczyk, and Bhuta declared having no competing interests. Ahmed declared receiving medical consultancy fees from Olympus, Odin Vision, Medtronic, and Norgine.
A version of this article appeared on Medscape.com.