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Sclerosing Mesenteritis: What GIs Need to Know About This Rare Disease
AGA has issued an updated pragmatic review on sclerosing mesenteritis (SM). Published in Clinical Gastroenterology and Hepatology, the update evaluates available evidence for diagnosis and treatment and examines opportunities for future research in SM, previously known by such names as misty mesentery, mesenteric panniculitis, and inflammatory pseudotumor.
Led by Mark T. Worthington, MD, AGAF, a professor of medicine in the Division of Gastroenterology and Hepatology at the University of Virginia in Charlottesville, Virginia, an expert AGA panel described SM as an uncommon benign idiopathic autoimmune disease of the mesenteric fat. Although of poorly understood etiology, gastroenterologists need to be prepared to diagnose it.
“CT radiologists increasingly are reporting SM and related lesions, such as misty mesentery,” Worthington told GI & Hepatology News. “We are also seeing new SM cases caused by immune checkpoint inhibitors in cancer treatment, and the oncologists ask us to manage this because it interferes with the treatment of the underlying malignancy. Those are often readily treated because we catch them so early.” Metabolic syndrome and associated conditions increase the risk for SM, as does aging.
The recent changes are intended to help clinicians predict disease activity and the need for other testing or treatment. “For instance, most cases are indolent and do not require aggressive treatment — often no treatment at all — but for those that are aggressive, we want the clinician to be able to identify those and make sure the treatment is appropriate. The aggressive cases may warrant tertiary referral,” Worthington said. “A secondary cancer is a possibility in this condition, so drawing from the SM radiology studies, we try to help the clinician decide who needs other testing, such as PET-CT or biopsy, and who can be monitored.”
As many as 60% of cases are asymptomatic, requiring no treatment. Abdominal pain is the most frequent symptom and its location on clinical examination should correspond to the SM lesion on imaging. Treatment involves anti-inflammatory medications tailored to disease severity and clinical response.
No biopsy is not necessary if the lesion meets three of the five CT criteria reported by B. Coulier and has no features of more aggressive disease or malignancy. Although some have suggested that SM may be a paraneoplastic syndrome, current evidence does not support this. SM needs to be differentiated from other diagnoses such as non-Hodgkin’s lymphoma, peritoneal carcinomatosis, and mesenteric fibromatosis.
“There are now CT guidelines for who actually has SM, who needs a biopsy or a PET-CT to rule-out malignancy, and who doesn’t,” said Worthington. “Radiologists do not always use the Coulier criteria for diagnosis, but often they will with encouragement. From this review, a GI clinician should be able to identify SM on CT.”
Epidemiologically, retrospective CT studies have reported a frequency of 0.6%-1.1%, the panelists noted. And while demographic data are limited, a large early case series reported that SM patients had a mean age of 55 years and more likely to be men and of White race.
Patients with SM do not have a higher prevalence of autoimmunity in general, but may have increased rates of metabolic syndrome, obesity, coronary artery disease, and urolithiasis, the panelists noted.
The update allows room for differences in clinical judgment. “For instance, a longer or more frequent CT surveillance interval can be justified depending on the patient’s findings, and no one should feel locked in by these recommendations,” Worthington said.
Medical Therapy
Although there is no surgical cure, pharmacologic options are many. These include prednisone, tamoxifen, colchicine, azathioprine, thalidomide, cyclophosphamide, and methotrexate, as well as the biologics rituximab, infliximab and ustekinumab. Current corticosteroid-based therapies often require months to achieve a clinical response, however.
Bowel obstruction is managed nonoperatively when feasible, but medically refractory disease may require surgical bypass.
Offering his perspective on the guidance but not involved in its formulation, Gastroenterologist Stephen B. Hanauer, MD, AGAF, a professor of medicine at Northwestern Medicine in Chicago, said, “The most useful component of the practical review is the algorithm for diagnosis and determination when biopsy or follow-up imaging is reasonable in the absence of evidence.” He stressed that the recommendations are pragmatic rather than evidence-based “as there are no controlled trials and the presentation is heterogeneous.”
Hanauer added that none of the recommended treatments have been shown to impact reduction on imaging. “Hence, all of the treatments are empiric without biological or imaging endpoints.”
In his experience, patients with inflammatory features are the best candidates for immune-directed therapies as reduction in inflammatory markers is a potential endpoint, although no therapies have demonstrated an effect on imaging or progression. “As an IBD doctor, I favor steroids and azathioprine or anti-TNF directed therapy, but again, there is no evidence beyond reports of symptomatic improvement.”
Worthington and colleagues agreed that treatment protocols have developed empirically. “Future investigation for symptomatic SM should focus on the nature of the inflammatory response, including causative cytokines and other proinflammatory mediators, the goal being targeted therapy with fewer side effects and a more rapid clinical response,” they wrote.
Currently, said Worthington, the biggest gaps remain in treatment. “Even the best studies are small and anecdotal, and we do not know the cytokine or other proinflammatory mediators.”
A version of this article appeared on Medscape.com.
AGA has issued an updated pragmatic review on sclerosing mesenteritis (SM). Published in Clinical Gastroenterology and Hepatology, the update evaluates available evidence for diagnosis and treatment and examines opportunities for future research in SM, previously known by such names as misty mesentery, mesenteric panniculitis, and inflammatory pseudotumor.
Led by Mark T. Worthington, MD, AGAF, a professor of medicine in the Division of Gastroenterology and Hepatology at the University of Virginia in Charlottesville, Virginia, an expert AGA panel described SM as an uncommon benign idiopathic autoimmune disease of the mesenteric fat. Although of poorly understood etiology, gastroenterologists need to be prepared to diagnose it.
“CT radiologists increasingly are reporting SM and related lesions, such as misty mesentery,” Worthington told GI & Hepatology News. “We are also seeing new SM cases caused by immune checkpoint inhibitors in cancer treatment, and the oncologists ask us to manage this because it interferes with the treatment of the underlying malignancy. Those are often readily treated because we catch them so early.” Metabolic syndrome and associated conditions increase the risk for SM, as does aging.
The recent changes are intended to help clinicians predict disease activity and the need for other testing or treatment. “For instance, most cases are indolent and do not require aggressive treatment — often no treatment at all — but for those that are aggressive, we want the clinician to be able to identify those and make sure the treatment is appropriate. The aggressive cases may warrant tertiary referral,” Worthington said. “A secondary cancer is a possibility in this condition, so drawing from the SM radiology studies, we try to help the clinician decide who needs other testing, such as PET-CT or biopsy, and who can be monitored.”
As many as 60% of cases are asymptomatic, requiring no treatment. Abdominal pain is the most frequent symptom and its location on clinical examination should correspond to the SM lesion on imaging. Treatment involves anti-inflammatory medications tailored to disease severity and clinical response.
No biopsy is not necessary if the lesion meets three of the five CT criteria reported by B. Coulier and has no features of more aggressive disease or malignancy. Although some have suggested that SM may be a paraneoplastic syndrome, current evidence does not support this. SM needs to be differentiated from other diagnoses such as non-Hodgkin’s lymphoma, peritoneal carcinomatosis, and mesenteric fibromatosis.
“There are now CT guidelines for who actually has SM, who needs a biopsy or a PET-CT to rule-out malignancy, and who doesn’t,” said Worthington. “Radiologists do not always use the Coulier criteria for diagnosis, but often they will with encouragement. From this review, a GI clinician should be able to identify SM on CT.”
Epidemiologically, retrospective CT studies have reported a frequency of 0.6%-1.1%, the panelists noted. And while demographic data are limited, a large early case series reported that SM patients had a mean age of 55 years and more likely to be men and of White race.
Patients with SM do not have a higher prevalence of autoimmunity in general, but may have increased rates of metabolic syndrome, obesity, coronary artery disease, and urolithiasis, the panelists noted.
The update allows room for differences in clinical judgment. “For instance, a longer or more frequent CT surveillance interval can be justified depending on the patient’s findings, and no one should feel locked in by these recommendations,” Worthington said.
Medical Therapy
Although there is no surgical cure, pharmacologic options are many. These include prednisone, tamoxifen, colchicine, azathioprine, thalidomide, cyclophosphamide, and methotrexate, as well as the biologics rituximab, infliximab and ustekinumab. Current corticosteroid-based therapies often require months to achieve a clinical response, however.
Bowel obstruction is managed nonoperatively when feasible, but medically refractory disease may require surgical bypass.
Offering his perspective on the guidance but not involved in its formulation, Gastroenterologist Stephen B. Hanauer, MD, AGAF, a professor of medicine at Northwestern Medicine in Chicago, said, “The most useful component of the practical review is the algorithm for diagnosis and determination when biopsy or follow-up imaging is reasonable in the absence of evidence.” He stressed that the recommendations are pragmatic rather than evidence-based “as there are no controlled trials and the presentation is heterogeneous.”
Hanauer added that none of the recommended treatments have been shown to impact reduction on imaging. “Hence, all of the treatments are empiric without biological or imaging endpoints.”
In his experience, patients with inflammatory features are the best candidates for immune-directed therapies as reduction in inflammatory markers is a potential endpoint, although no therapies have demonstrated an effect on imaging or progression. “As an IBD doctor, I favor steroids and azathioprine or anti-TNF directed therapy, but again, there is no evidence beyond reports of symptomatic improvement.”
Worthington and colleagues agreed that treatment protocols have developed empirically. “Future investigation for symptomatic SM should focus on the nature of the inflammatory response, including causative cytokines and other proinflammatory mediators, the goal being targeted therapy with fewer side effects and a more rapid clinical response,” they wrote.
Currently, said Worthington, the biggest gaps remain in treatment. “Even the best studies are small and anecdotal, and we do not know the cytokine or other proinflammatory mediators.”
A version of this article appeared on Medscape.com.
AGA has issued an updated pragmatic review on sclerosing mesenteritis (SM). Published in Clinical Gastroenterology and Hepatology, the update evaluates available evidence for diagnosis and treatment and examines opportunities for future research in SM, previously known by such names as misty mesentery, mesenteric panniculitis, and inflammatory pseudotumor.
Led by Mark T. Worthington, MD, AGAF, a professor of medicine in the Division of Gastroenterology and Hepatology at the University of Virginia in Charlottesville, Virginia, an expert AGA panel described SM as an uncommon benign idiopathic autoimmune disease of the mesenteric fat. Although of poorly understood etiology, gastroenterologists need to be prepared to diagnose it.
“CT radiologists increasingly are reporting SM and related lesions, such as misty mesentery,” Worthington told GI & Hepatology News. “We are also seeing new SM cases caused by immune checkpoint inhibitors in cancer treatment, and the oncologists ask us to manage this because it interferes with the treatment of the underlying malignancy. Those are often readily treated because we catch them so early.” Metabolic syndrome and associated conditions increase the risk for SM, as does aging.
The recent changes are intended to help clinicians predict disease activity and the need for other testing or treatment. “For instance, most cases are indolent and do not require aggressive treatment — often no treatment at all — but for those that are aggressive, we want the clinician to be able to identify those and make sure the treatment is appropriate. The aggressive cases may warrant tertiary referral,” Worthington said. “A secondary cancer is a possibility in this condition, so drawing from the SM radiology studies, we try to help the clinician decide who needs other testing, such as PET-CT or biopsy, and who can be monitored.”
As many as 60% of cases are asymptomatic, requiring no treatment. Abdominal pain is the most frequent symptom and its location on clinical examination should correspond to the SM lesion on imaging. Treatment involves anti-inflammatory medications tailored to disease severity and clinical response.
No biopsy is not necessary if the lesion meets three of the five CT criteria reported by B. Coulier and has no features of more aggressive disease or malignancy. Although some have suggested that SM may be a paraneoplastic syndrome, current evidence does not support this. SM needs to be differentiated from other diagnoses such as non-Hodgkin’s lymphoma, peritoneal carcinomatosis, and mesenteric fibromatosis.
“There are now CT guidelines for who actually has SM, who needs a biopsy or a PET-CT to rule-out malignancy, and who doesn’t,” said Worthington. “Radiologists do not always use the Coulier criteria for diagnosis, but often they will with encouragement. From this review, a GI clinician should be able to identify SM on CT.”
Epidemiologically, retrospective CT studies have reported a frequency of 0.6%-1.1%, the panelists noted. And while demographic data are limited, a large early case series reported that SM patients had a mean age of 55 years and more likely to be men and of White race.
Patients with SM do not have a higher prevalence of autoimmunity in general, but may have increased rates of metabolic syndrome, obesity, coronary artery disease, and urolithiasis, the panelists noted.
The update allows room for differences in clinical judgment. “For instance, a longer or more frequent CT surveillance interval can be justified depending on the patient’s findings, and no one should feel locked in by these recommendations,” Worthington said.
Medical Therapy
Although there is no surgical cure, pharmacologic options are many. These include prednisone, tamoxifen, colchicine, azathioprine, thalidomide, cyclophosphamide, and methotrexate, as well as the biologics rituximab, infliximab and ustekinumab. Current corticosteroid-based therapies often require months to achieve a clinical response, however.
Bowel obstruction is managed nonoperatively when feasible, but medically refractory disease may require surgical bypass.
Offering his perspective on the guidance but not involved in its formulation, Gastroenterologist Stephen B. Hanauer, MD, AGAF, a professor of medicine at Northwestern Medicine in Chicago, said, “The most useful component of the practical review is the algorithm for diagnosis and determination when biopsy or follow-up imaging is reasonable in the absence of evidence.” He stressed that the recommendations are pragmatic rather than evidence-based “as there are no controlled trials and the presentation is heterogeneous.”
Hanauer added that none of the recommended treatments have been shown to impact reduction on imaging. “Hence, all of the treatments are empiric without biological or imaging endpoints.”
In his experience, patients with inflammatory features are the best candidates for immune-directed therapies as reduction in inflammatory markers is a potential endpoint, although no therapies have demonstrated an effect on imaging or progression. “As an IBD doctor, I favor steroids and azathioprine or anti-TNF directed therapy, but again, there is no evidence beyond reports of symptomatic improvement.”
Worthington and colleagues agreed that treatment protocols have developed empirically. “Future investigation for symptomatic SM should focus on the nature of the inflammatory response, including causative cytokines and other proinflammatory mediators, the goal being targeted therapy with fewer side effects and a more rapid clinical response,” they wrote.
Currently, said Worthington, the biggest gaps remain in treatment. “Even the best studies are small and anecdotal, and we do not know the cytokine or other proinflammatory mediators.”
A version of this article appeared on Medscape.com.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Celiac Blood Test Eliminates Need for Eating Gluten
Think your patient may have celiac disease? The harsh reality is that current diagnostic tests require patients to consume gluten for an accurate diagnosis, which poses challenges for individuals already avoiding gluten.
A more tolerable approach appears to be on the horizon.
“This is a simple and accurate test that can provide a diagnosis within a very short time frame, without the need for patients to continue eating gluten and feeling sick, or to wait months for a gastroscopy,” Olivia Moscatelli, PhD candidate, Tye-Din Lab, Walter and Eliza Hall Institute and University of Melbourne, Parkville, Australia, told GI & Hepatology News.
The study was published in Gastroenterology.
Most Cases Go Undiagnosed
Celiac disease is an autoimmune disorder triggered by gluten found in wheat, rye, and barley. The only available treatment is a strict, life-long gluten-free diet.
The global prevalence of celiac disease is estimated at around 1%-2%, with 50%-80% of cases either undiagnosed or diagnosed late. That’s because the current reliable diagnosis of celiac disease requires the intake of gluten, which may deter people from seeking a diagnosis.
In earlier work, the researchers, working with Robert Anderson, MBChB, BMedSc, PhD, AGAF, now with Novoviah Pharmaceuticals, made the unexpected discovery that interleukin-2 (IL-2) spiked in the blood of people with celiac disease shortly after they ate gluten.
But would this signal be present when no gluten had been consumed?
The team developed and tested a simple whole blood assay measuring IL-2 release (WBAIL- 2) for detecting gluten-specific T cells to aid in diagnosing celiac disease.
They collected blood samples from 181 volunteers — 75 with treated celiac disease on a gluten-free diet, 13 with active untreated celiac disease, 32 with nonceliac gluten sensitivity and 61 healthy controls. The blood samples were mixed with gluten in a test tube for a day to see if the IL-2 signal appeared.
The WBAIL-2 assay demonstrated high accuracy for celiac disease, even in patients following a strict gluten-free diet.
For patients with HLA-DQ2.5+ genetics, sensitivity was 90% and specificity was 95%, with lower sensitivity (56%) for patients with HLA-DQ8+ celiac disease.
The WBAIL-2 assay correlated strongly with the frequency of tetramer-positive gluten-specific CD4+ T cells used to diagnose celiac disease and monitor treatment effectiveness, and with serum IL-2 levels after gluten challenge.
The strength of the IL-2 signal correlated with the severity of a patient’s symptoms, “allowing us to predict how severely a person with celiac disease might react to gluten, without them actually having to eat it,” Moscatelli said in a news release.
“Current diagnostic practice involves a blood-based serology test followed by a confirmatory gastroscopy if positive. Both tests require the patient to eat gluten daily for 6-12 weeks prior for accurate results. We envision the new blood test (IL-2 whole blood assay) will replace the invasive gastroscopy as the confirmatory test following positive serology,” Moscatelli told GI & Hepatology News.
“In people already following a gluten-free diet, we propose they would have this new blood test done on two separate occasions and two positive results would be required for a celiac diagnosis. This would allow a large number of people who previously have been unable to go through the current diagnostic process to receive a diagnosis,” Moscatelli said.
Practice Changing Potential
A blood-based test that can accurately detect celiac disease without the need for a gluten challenge would be “welcome and practice changing,” said Christopher Cao, MD, director, Celiac Disease Program, Division of Gastroenterology, Mount Sinai Health System, New York City.
“A typical ‘gluten challenge’ involves eating the equivalent of 1-2 slices of bread daily for the course of 6 weeks, and this may be incredibly difficult for patients who have already been on a gluten-free diet prior to an official celiac disease diagnosis. Inability to perform a gluten challenge limits the ability to make an accurate celiac disease diagnosis,” Cao told GI & Hepatology News.
“This study shows that gluten-stimulated interleukin release 2 assays may correlate with the presence of pathogenic gluten-specific CD4+ T cell response in celiac disease,” Cao noted.
He cautioned that “further large cohort, multicenter prospective studies are needed to assess generalizability and may be helpful in evaluating the accuracy of WBAIL-2 in non-HLA DQ2.5 genotypes.”
Other considerations prior to implementation may include reproducibility across different laboratories and overall cost effectiveness, Cao said. “Ultimately in clinic, the role of WBAIL-2 will need to be better defined within the algorithm of celiac disease testing,” he added.
The Path Ahead
The researchers plan to test the performance of the IL-2 whole blood assay in a pediatric cohort, as well as in other countries to demonstrate the reproducibility of the test. In these studies, the test will likely be performed alongside the current diagnostic tests (serology and gastroscopy), Moscatelli told GI & Hepatology News.
“There are some validation studies starting in other countries already as many celiac clinicians globally are interested in bringing this test to their clinical practice. I believe the plan is to have this as an approved diagnostic test for celiac disease worldwide,” she said.
Novoviah Pharmaceuticals is managing the commercialization of the test, and the plan is to get it into clinical practice in the next 2 years, Moscatelli said.
The research was supported by Coeliac Australia, Novoviah Pharmaceuticals (who provided the proprietary test for this study), Beck Family Foundation, Butterfield Family, the Veith Foundation. A complete list of author disclosures is available with the original article. Cao had no relevant disclosures.
A version of this article appeared on Medscape.com.
Think your patient may have celiac disease? The harsh reality is that current diagnostic tests require patients to consume gluten for an accurate diagnosis, which poses challenges for individuals already avoiding gluten.
A more tolerable approach appears to be on the horizon.
“This is a simple and accurate test that can provide a diagnosis within a very short time frame, without the need for patients to continue eating gluten and feeling sick, or to wait months for a gastroscopy,” Olivia Moscatelli, PhD candidate, Tye-Din Lab, Walter and Eliza Hall Institute and University of Melbourne, Parkville, Australia, told GI & Hepatology News.
The study was published in Gastroenterology.
Most Cases Go Undiagnosed
Celiac disease is an autoimmune disorder triggered by gluten found in wheat, rye, and barley. The only available treatment is a strict, life-long gluten-free diet.
The global prevalence of celiac disease is estimated at around 1%-2%, with 50%-80% of cases either undiagnosed or diagnosed late. That’s because the current reliable diagnosis of celiac disease requires the intake of gluten, which may deter people from seeking a diagnosis.
In earlier work, the researchers, working with Robert Anderson, MBChB, BMedSc, PhD, AGAF, now with Novoviah Pharmaceuticals, made the unexpected discovery that interleukin-2 (IL-2) spiked in the blood of people with celiac disease shortly after they ate gluten.
But would this signal be present when no gluten had been consumed?
The team developed and tested a simple whole blood assay measuring IL-2 release (WBAIL- 2) for detecting gluten-specific T cells to aid in diagnosing celiac disease.
They collected blood samples from 181 volunteers — 75 with treated celiac disease on a gluten-free diet, 13 with active untreated celiac disease, 32 with nonceliac gluten sensitivity and 61 healthy controls. The blood samples were mixed with gluten in a test tube for a day to see if the IL-2 signal appeared.
The WBAIL-2 assay demonstrated high accuracy for celiac disease, even in patients following a strict gluten-free diet.
For patients with HLA-DQ2.5+ genetics, sensitivity was 90% and specificity was 95%, with lower sensitivity (56%) for patients with HLA-DQ8+ celiac disease.
The WBAIL-2 assay correlated strongly with the frequency of tetramer-positive gluten-specific CD4+ T cells used to diagnose celiac disease and monitor treatment effectiveness, and with serum IL-2 levels after gluten challenge.
The strength of the IL-2 signal correlated with the severity of a patient’s symptoms, “allowing us to predict how severely a person with celiac disease might react to gluten, without them actually having to eat it,” Moscatelli said in a news release.
“Current diagnostic practice involves a blood-based serology test followed by a confirmatory gastroscopy if positive. Both tests require the patient to eat gluten daily for 6-12 weeks prior for accurate results. We envision the new blood test (IL-2 whole blood assay) will replace the invasive gastroscopy as the confirmatory test following positive serology,” Moscatelli told GI & Hepatology News.
“In people already following a gluten-free diet, we propose they would have this new blood test done on two separate occasions and two positive results would be required for a celiac diagnosis. This would allow a large number of people who previously have been unable to go through the current diagnostic process to receive a diagnosis,” Moscatelli said.
Practice Changing Potential
A blood-based test that can accurately detect celiac disease without the need for a gluten challenge would be “welcome and practice changing,” said Christopher Cao, MD, director, Celiac Disease Program, Division of Gastroenterology, Mount Sinai Health System, New York City.
“A typical ‘gluten challenge’ involves eating the equivalent of 1-2 slices of bread daily for the course of 6 weeks, and this may be incredibly difficult for patients who have already been on a gluten-free diet prior to an official celiac disease diagnosis. Inability to perform a gluten challenge limits the ability to make an accurate celiac disease diagnosis,” Cao told GI & Hepatology News.
“This study shows that gluten-stimulated interleukin release 2 assays may correlate with the presence of pathogenic gluten-specific CD4+ T cell response in celiac disease,” Cao noted.
He cautioned that “further large cohort, multicenter prospective studies are needed to assess generalizability and may be helpful in evaluating the accuracy of WBAIL-2 in non-HLA DQ2.5 genotypes.”
Other considerations prior to implementation may include reproducibility across different laboratories and overall cost effectiveness, Cao said. “Ultimately in clinic, the role of WBAIL-2 will need to be better defined within the algorithm of celiac disease testing,” he added.
The Path Ahead
The researchers plan to test the performance of the IL-2 whole blood assay in a pediatric cohort, as well as in other countries to demonstrate the reproducibility of the test. In these studies, the test will likely be performed alongside the current diagnostic tests (serology and gastroscopy), Moscatelli told GI & Hepatology News.
“There are some validation studies starting in other countries already as many celiac clinicians globally are interested in bringing this test to their clinical practice. I believe the plan is to have this as an approved diagnostic test for celiac disease worldwide,” she said.
Novoviah Pharmaceuticals is managing the commercialization of the test, and the plan is to get it into clinical practice in the next 2 years, Moscatelli said.
The research was supported by Coeliac Australia, Novoviah Pharmaceuticals (who provided the proprietary test for this study), Beck Family Foundation, Butterfield Family, the Veith Foundation. A complete list of author disclosures is available with the original article. Cao had no relevant disclosures.
A version of this article appeared on Medscape.com.
Think your patient may have celiac disease? The harsh reality is that current diagnostic tests require patients to consume gluten for an accurate diagnosis, which poses challenges for individuals already avoiding gluten.
A more tolerable approach appears to be on the horizon.
“This is a simple and accurate test that can provide a diagnosis within a very short time frame, without the need for patients to continue eating gluten and feeling sick, or to wait months for a gastroscopy,” Olivia Moscatelli, PhD candidate, Tye-Din Lab, Walter and Eliza Hall Institute and University of Melbourne, Parkville, Australia, told GI & Hepatology News.
The study was published in Gastroenterology.
Most Cases Go Undiagnosed
Celiac disease is an autoimmune disorder triggered by gluten found in wheat, rye, and barley. The only available treatment is a strict, life-long gluten-free diet.
The global prevalence of celiac disease is estimated at around 1%-2%, with 50%-80% of cases either undiagnosed or diagnosed late. That’s because the current reliable diagnosis of celiac disease requires the intake of gluten, which may deter people from seeking a diagnosis.
In earlier work, the researchers, working with Robert Anderson, MBChB, BMedSc, PhD, AGAF, now with Novoviah Pharmaceuticals, made the unexpected discovery that interleukin-2 (IL-2) spiked in the blood of people with celiac disease shortly after they ate gluten.
But would this signal be present when no gluten had been consumed?
The team developed and tested a simple whole blood assay measuring IL-2 release (WBAIL- 2) for detecting gluten-specific T cells to aid in diagnosing celiac disease.
They collected blood samples from 181 volunteers — 75 with treated celiac disease on a gluten-free diet, 13 with active untreated celiac disease, 32 with nonceliac gluten sensitivity and 61 healthy controls. The blood samples were mixed with gluten in a test tube for a day to see if the IL-2 signal appeared.
The WBAIL-2 assay demonstrated high accuracy for celiac disease, even in patients following a strict gluten-free diet.
For patients with HLA-DQ2.5+ genetics, sensitivity was 90% and specificity was 95%, with lower sensitivity (56%) for patients with HLA-DQ8+ celiac disease.
The WBAIL-2 assay correlated strongly with the frequency of tetramer-positive gluten-specific CD4+ T cells used to diagnose celiac disease and monitor treatment effectiveness, and with serum IL-2 levels after gluten challenge.
The strength of the IL-2 signal correlated with the severity of a patient’s symptoms, “allowing us to predict how severely a person with celiac disease might react to gluten, without them actually having to eat it,” Moscatelli said in a news release.
“Current diagnostic practice involves a blood-based serology test followed by a confirmatory gastroscopy if positive. Both tests require the patient to eat gluten daily for 6-12 weeks prior for accurate results. We envision the new blood test (IL-2 whole blood assay) will replace the invasive gastroscopy as the confirmatory test following positive serology,” Moscatelli told GI & Hepatology News.
“In people already following a gluten-free diet, we propose they would have this new blood test done on two separate occasions and two positive results would be required for a celiac diagnosis. This would allow a large number of people who previously have been unable to go through the current diagnostic process to receive a diagnosis,” Moscatelli said.
Practice Changing Potential
A blood-based test that can accurately detect celiac disease without the need for a gluten challenge would be “welcome and practice changing,” said Christopher Cao, MD, director, Celiac Disease Program, Division of Gastroenterology, Mount Sinai Health System, New York City.
“A typical ‘gluten challenge’ involves eating the equivalent of 1-2 slices of bread daily for the course of 6 weeks, and this may be incredibly difficult for patients who have already been on a gluten-free diet prior to an official celiac disease diagnosis. Inability to perform a gluten challenge limits the ability to make an accurate celiac disease diagnosis,” Cao told GI & Hepatology News.
“This study shows that gluten-stimulated interleukin release 2 assays may correlate with the presence of pathogenic gluten-specific CD4+ T cell response in celiac disease,” Cao noted.
He cautioned that “further large cohort, multicenter prospective studies are needed to assess generalizability and may be helpful in evaluating the accuracy of WBAIL-2 in non-HLA DQ2.5 genotypes.”
Other considerations prior to implementation may include reproducibility across different laboratories and overall cost effectiveness, Cao said. “Ultimately in clinic, the role of WBAIL-2 will need to be better defined within the algorithm of celiac disease testing,” he added.
The Path Ahead
The researchers plan to test the performance of the IL-2 whole blood assay in a pediatric cohort, as well as in other countries to demonstrate the reproducibility of the test. In these studies, the test will likely be performed alongside the current diagnostic tests (serology and gastroscopy), Moscatelli told GI & Hepatology News.
“There are some validation studies starting in other countries already as many celiac clinicians globally are interested in bringing this test to their clinical practice. I believe the plan is to have this as an approved diagnostic test for celiac disease worldwide,” she said.
Novoviah Pharmaceuticals is managing the commercialization of the test, and the plan is to get it into clinical practice in the next 2 years, Moscatelli said.
The research was supported by Coeliac Australia, Novoviah Pharmaceuticals (who provided the proprietary test for this study), Beck Family Foundation, Butterfield Family, the Veith Foundation. A complete list of author disclosures is available with the original article. Cao had no relevant disclosures.
A version of this article appeared on Medscape.com.
FROM GASTROENTEROLOGY
Can Modulation of the Microbiome Improve Cancer Immunotherapy Tolerance and Efficacy?
WASHINGTON — For years, oncologist Jonathan Peled, MD, PhD, and his colleagues at Memorial Sloan Kettering Cancer Center (MSKCC) in New York City have been documenting gut microbiota disruption during allogeneic hematopoietic stem cell transplantation (allo-HSCT) and its role in frequent and potentially fatal bloodstream infections (BSIs) in the first 100 days after transplant.
, and at the Gut Microbiota for Health (GMFH) World Summit 2025, Peled shared two new findings.
In one study, his team found that sucrose can exacerbate antibiotic-induced microbiome injury in patients undergoing allo-HSCT — a finding that “raises the question of whether our dietary recommendations [for] allo-HSCT patients are correct,” said Peled, assistant attending at MSKCC, during a session on the gut microbiome and oncology.
And in another study, they found that a rationally designed probiotic formulation may help lower the incidence of bacterial BSIs. In December 2024, the probiotic formulation (SER-155, Seres Therapeutics, Inc.) was granted breakthrough therapy designation by the FDA.
With immunotherapies more broadly, researchers are increasingly looking at diet and modulation of the microbiome to improve both treatment tolerance and efficacy, experts said at the meeting convened by the AGA and the European Society of Neurogastroenterology and Motility.
“Cancer patients and caregivers are asking, ‘What should I eat?’” said Carrie Daniel-MacDougall, PhD, MPH, a nutritional epidemiologist at the University of Texas MD Anderson Cancer Center in Houston. “They’re not just focused on side effects — they want a good outcome for their treatment, and they’re exploring a lot of dietary strategies [for which there] is not a lot of evidence.”
Clinicians are challenged by the fact that “we don’t typically collect dietary data in clinical trials of cancer drugs,” leaving them to extrapolate from evidence-based diet guidelines for cancer prevention, Daniel-MacDougall said.
But “I think that’s starting to shift,” she said, with the microbiome being increasingly recognized for its potential influences on therapeutic response and clinical trials underway looking at “a healthy dietary pattern not just for prevention but survival.”
Diet and Probiotics After allo-HSCT
The patterns of microbiota disruption during allo-HSCT — a procedure that includes antibiotic administration, chemotherapy, and sometimes irradiation — are characterized by loss of diversity and the expansion of potentially pathogenic organisms, most commonly Enterococcus, said Peled.
This has been demonstrated across transplantation centers. In a multicenter, international study published in 2020, the patterns of microbiota disruption and their impact on mortality were similar across MSK and other transplantation centers, with higher diversity of intestinal microbiota associated with lower mortality.
Other studies have shown that Enterococcus domination alone (defined arbitrarily as > 30% of fecal microbial composition) is associated with graft vs host disease and higher mortality after allo-HSCT and that intestinal domination by Proteobacteria coincides temporally with BSIs, he said.
Autologous fecal microbiota transplantation (FMT) has been shown to largely restore the microbiota composition the patient had before antibiotic treatment and allo-HSCT, he said, making fecal sample banking and posttreatment FMT a potential approach for reconstituting the gut microbiome and improving outcomes.
But “lately we’ve been very interested in diet for modulating [harmful] patterns” in the microbiome composition, Peled said.
In the new study suggesting a role for sugar avoidance, published last year as a bioRxiv preprint, Peled and his colleagues collected real-time dietary intake data (40,702 food entries) from 173 patients hospitalized for several weeks for allo-HSCT at MSK and analyzed it alongside longitudinally collected fecal samples. They used a Bayesian mixed-effects model to identify dietary components that may correlate with microbial disruption.
“What jumped out as very predictive of a low diversity fecal sample [and expansion of Enterococcus] in the 2 days prior to collection was the interaction between antibiotics and the consumption of sweets” — foods rich in simple sugars, Peled said. The relationship between sugar and the microbiome occurred only during periods of antibiotic exposure.
“And it was particularly perplexing because the foods that fall into the ‘sweets’ category are foods we encourage people to eat clinically when they’re not feeling well and food intake drops dramatically,” he said. This includes foods like nutritional drinks or shakes, Italian ice, gelatin dessert, and sports drinks.
(In a mouse model of post-antibiotic Enterococcus expansion, Peled and his co-investigators then validated the findings and ruled out the impact of any reductions in fiber.)
In addition to possibly revising dietary recommendations for patients undergoing allo-HSCT, the findings raise the question of whether avoiding sugar intake while on antibiotics, in general, is a way to mitigate antibiotic-induced dysbiosis, he said.
To test the role of probiotics, Peled and colleagues collaborated with Seres Therapeutics on a phase 1b trial of an oral combination (SER-155) of 16 fermented strains “selected rationally,” he said, for their ability to decolonize gut pathogens, improve gut barrier function (in vitro), and reduce gut inflammation and local immune activation.
After a safety lead-in, patients were randomized to receive SER-155 (20) or placebo (14) three times — prior to transplant, upon neutrophil engraftment (with vancomycin “conditioning”), and after transplant. “The strains succeeded in grafting in the [gastrointestinal] GI tract…and some of them persisted all the way through to day 100,” Peled said.
The incidence of pathogen domination was substantially lower in the probiotic recipients compared to an MSK historical control cohort, and the incidence of BSIs was significantly lower compared to the placebo arm (10% vs 43%, respectively, representing a 77% relative risk reduction), he said.
Diet and Immunotherapy Response: Trials at MD Anderson
One of the first trials Daniel-MacDougall launched at MD Anderson on diet and the microbiome randomized 55 patients who were obese and had a history of colorectal cancer or precancerous polyps to add a cup of beans to their usual diet or to continue their usual diet without beans. There was a crossover at 8 weeks in the 16-week BE GONE trial; stool and fasting blood were collected every 4 weeks.
“Beans are a prebiotic super-house in my opinion, and they’re also something this population would avoid,” said Daniel-MacDougall, associate professor in the department of epidemiology at MD Anderson and faculty director of the Bionutrition Research Core and Research Kitchen.
“We saw a modest increase in alpha diversity [in the intervention group] and similar trends with microbiota-derived metabolites” that regressed when patients returned to their usual diet, she said. The researchers also documented decreases in proteomic biomarkers of intestinal and systemic immune and inflammatory response.
The impact of diet on cancer survival was shown in subsequent research, including an observational study published in Science in 2021 of patients with melanoma receiving immune checkpoint blockade (ICB) treatment. “Patients who consumed insufficient dietary fiber at the start of therapy tended to do worse [than those reporting sufficient fiber intake],” with significantly lower progression-free survival, Daniel-MacDougall said.
“And interestingly, when we looked at dietary fiber [with and without] probiotic use, patients who had sufficient fiber but did not take probiotics did the best,” she said. [The probiotics were not endorsed or selected by their physicians.]
Now, the researchers at MD Anderson are moving into “precision nutrition” research, Daniel-MacDougall said, with a phase 2 randomized, double-blind trial of high dietary fiber intake (a target of 50 g/d from whole foods) vs a healthy control diet (20 g/d of fiber) in patients with melanoma receiving ICB.
The study, which is underway, is a fully controlled feeding study, with all meals and snacks provided by MD Anderson and macronutrients controlled. Researchers are collecting blood, stool, and tumor tissue (if available) to answer questions about the microbiome, changes in systemic and tissue immunity, disease response and immunotherapy toxicity, and other issues.
Peled disclosed IP licensing and research support from Seres Therapeutics; consulting with Da Volterra, MaaT Pharma, and CSL Behring; and advisory/equity with Postbiotics + Research LLC and Prodigy Biosciences. Daniel-MacDougall reported having no disclosures.
A version of this article appeared on Medscape.com.
WASHINGTON — For years, oncologist Jonathan Peled, MD, PhD, and his colleagues at Memorial Sloan Kettering Cancer Center (MSKCC) in New York City have been documenting gut microbiota disruption during allogeneic hematopoietic stem cell transplantation (allo-HSCT) and its role in frequent and potentially fatal bloodstream infections (BSIs) in the first 100 days after transplant.
, and at the Gut Microbiota for Health (GMFH) World Summit 2025, Peled shared two new findings.
In one study, his team found that sucrose can exacerbate antibiotic-induced microbiome injury in patients undergoing allo-HSCT — a finding that “raises the question of whether our dietary recommendations [for] allo-HSCT patients are correct,” said Peled, assistant attending at MSKCC, during a session on the gut microbiome and oncology.
And in another study, they found that a rationally designed probiotic formulation may help lower the incidence of bacterial BSIs. In December 2024, the probiotic formulation (SER-155, Seres Therapeutics, Inc.) was granted breakthrough therapy designation by the FDA.
With immunotherapies more broadly, researchers are increasingly looking at diet and modulation of the microbiome to improve both treatment tolerance and efficacy, experts said at the meeting convened by the AGA and the European Society of Neurogastroenterology and Motility.
“Cancer patients and caregivers are asking, ‘What should I eat?’” said Carrie Daniel-MacDougall, PhD, MPH, a nutritional epidemiologist at the University of Texas MD Anderson Cancer Center in Houston. “They’re not just focused on side effects — they want a good outcome for their treatment, and they’re exploring a lot of dietary strategies [for which there] is not a lot of evidence.”
Clinicians are challenged by the fact that “we don’t typically collect dietary data in clinical trials of cancer drugs,” leaving them to extrapolate from evidence-based diet guidelines for cancer prevention, Daniel-MacDougall said.
But “I think that’s starting to shift,” she said, with the microbiome being increasingly recognized for its potential influences on therapeutic response and clinical trials underway looking at “a healthy dietary pattern not just for prevention but survival.”
Diet and Probiotics After allo-HSCT
The patterns of microbiota disruption during allo-HSCT — a procedure that includes antibiotic administration, chemotherapy, and sometimes irradiation — are characterized by loss of diversity and the expansion of potentially pathogenic organisms, most commonly Enterococcus, said Peled.
This has been demonstrated across transplantation centers. In a multicenter, international study published in 2020, the patterns of microbiota disruption and their impact on mortality were similar across MSK and other transplantation centers, with higher diversity of intestinal microbiota associated with lower mortality.
Other studies have shown that Enterococcus domination alone (defined arbitrarily as > 30% of fecal microbial composition) is associated with graft vs host disease and higher mortality after allo-HSCT and that intestinal domination by Proteobacteria coincides temporally with BSIs, he said.
Autologous fecal microbiota transplantation (FMT) has been shown to largely restore the microbiota composition the patient had before antibiotic treatment and allo-HSCT, he said, making fecal sample banking and posttreatment FMT a potential approach for reconstituting the gut microbiome and improving outcomes.
But “lately we’ve been very interested in diet for modulating [harmful] patterns” in the microbiome composition, Peled said.
In the new study suggesting a role for sugar avoidance, published last year as a bioRxiv preprint, Peled and his colleagues collected real-time dietary intake data (40,702 food entries) from 173 patients hospitalized for several weeks for allo-HSCT at MSK and analyzed it alongside longitudinally collected fecal samples. They used a Bayesian mixed-effects model to identify dietary components that may correlate with microbial disruption.
“What jumped out as very predictive of a low diversity fecal sample [and expansion of Enterococcus] in the 2 days prior to collection was the interaction between antibiotics and the consumption of sweets” — foods rich in simple sugars, Peled said. The relationship between sugar and the microbiome occurred only during periods of antibiotic exposure.
“And it was particularly perplexing because the foods that fall into the ‘sweets’ category are foods we encourage people to eat clinically when they’re not feeling well and food intake drops dramatically,” he said. This includes foods like nutritional drinks or shakes, Italian ice, gelatin dessert, and sports drinks.
(In a mouse model of post-antibiotic Enterococcus expansion, Peled and his co-investigators then validated the findings and ruled out the impact of any reductions in fiber.)
In addition to possibly revising dietary recommendations for patients undergoing allo-HSCT, the findings raise the question of whether avoiding sugar intake while on antibiotics, in general, is a way to mitigate antibiotic-induced dysbiosis, he said.
To test the role of probiotics, Peled and colleagues collaborated with Seres Therapeutics on a phase 1b trial of an oral combination (SER-155) of 16 fermented strains “selected rationally,” he said, for their ability to decolonize gut pathogens, improve gut barrier function (in vitro), and reduce gut inflammation and local immune activation.
After a safety lead-in, patients were randomized to receive SER-155 (20) or placebo (14) three times — prior to transplant, upon neutrophil engraftment (with vancomycin “conditioning”), and after transplant. “The strains succeeded in grafting in the [gastrointestinal] GI tract…and some of them persisted all the way through to day 100,” Peled said.
The incidence of pathogen domination was substantially lower in the probiotic recipients compared to an MSK historical control cohort, and the incidence of BSIs was significantly lower compared to the placebo arm (10% vs 43%, respectively, representing a 77% relative risk reduction), he said.
Diet and Immunotherapy Response: Trials at MD Anderson
One of the first trials Daniel-MacDougall launched at MD Anderson on diet and the microbiome randomized 55 patients who were obese and had a history of colorectal cancer or precancerous polyps to add a cup of beans to their usual diet or to continue their usual diet without beans. There was a crossover at 8 weeks in the 16-week BE GONE trial; stool and fasting blood were collected every 4 weeks.
“Beans are a prebiotic super-house in my opinion, and they’re also something this population would avoid,” said Daniel-MacDougall, associate professor in the department of epidemiology at MD Anderson and faculty director of the Bionutrition Research Core and Research Kitchen.
“We saw a modest increase in alpha diversity [in the intervention group] and similar trends with microbiota-derived metabolites” that regressed when patients returned to their usual diet, she said. The researchers also documented decreases in proteomic biomarkers of intestinal and systemic immune and inflammatory response.
The impact of diet on cancer survival was shown in subsequent research, including an observational study published in Science in 2021 of patients with melanoma receiving immune checkpoint blockade (ICB) treatment. “Patients who consumed insufficient dietary fiber at the start of therapy tended to do worse [than those reporting sufficient fiber intake],” with significantly lower progression-free survival, Daniel-MacDougall said.
“And interestingly, when we looked at dietary fiber [with and without] probiotic use, patients who had sufficient fiber but did not take probiotics did the best,” she said. [The probiotics were not endorsed or selected by their physicians.]
Now, the researchers at MD Anderson are moving into “precision nutrition” research, Daniel-MacDougall said, with a phase 2 randomized, double-blind trial of high dietary fiber intake (a target of 50 g/d from whole foods) vs a healthy control diet (20 g/d of fiber) in patients with melanoma receiving ICB.
The study, which is underway, is a fully controlled feeding study, with all meals and snacks provided by MD Anderson and macronutrients controlled. Researchers are collecting blood, stool, and tumor tissue (if available) to answer questions about the microbiome, changes in systemic and tissue immunity, disease response and immunotherapy toxicity, and other issues.
Peled disclosed IP licensing and research support from Seres Therapeutics; consulting with Da Volterra, MaaT Pharma, and CSL Behring; and advisory/equity with Postbiotics + Research LLC and Prodigy Biosciences. Daniel-MacDougall reported having no disclosures.
A version of this article appeared on Medscape.com.
WASHINGTON — For years, oncologist Jonathan Peled, MD, PhD, and his colleagues at Memorial Sloan Kettering Cancer Center (MSKCC) in New York City have been documenting gut microbiota disruption during allogeneic hematopoietic stem cell transplantation (allo-HSCT) and its role in frequent and potentially fatal bloodstream infections (BSIs) in the first 100 days after transplant.
, and at the Gut Microbiota for Health (GMFH) World Summit 2025, Peled shared two new findings.
In one study, his team found that sucrose can exacerbate antibiotic-induced microbiome injury in patients undergoing allo-HSCT — a finding that “raises the question of whether our dietary recommendations [for] allo-HSCT patients are correct,” said Peled, assistant attending at MSKCC, during a session on the gut microbiome and oncology.
And in another study, they found that a rationally designed probiotic formulation may help lower the incidence of bacterial BSIs. In December 2024, the probiotic formulation (SER-155, Seres Therapeutics, Inc.) was granted breakthrough therapy designation by the FDA.
With immunotherapies more broadly, researchers are increasingly looking at diet and modulation of the microbiome to improve both treatment tolerance and efficacy, experts said at the meeting convened by the AGA and the European Society of Neurogastroenterology and Motility.
“Cancer patients and caregivers are asking, ‘What should I eat?’” said Carrie Daniel-MacDougall, PhD, MPH, a nutritional epidemiologist at the University of Texas MD Anderson Cancer Center in Houston. “They’re not just focused on side effects — they want a good outcome for their treatment, and they’re exploring a lot of dietary strategies [for which there] is not a lot of evidence.”
Clinicians are challenged by the fact that “we don’t typically collect dietary data in clinical trials of cancer drugs,” leaving them to extrapolate from evidence-based diet guidelines for cancer prevention, Daniel-MacDougall said.
But “I think that’s starting to shift,” she said, with the microbiome being increasingly recognized for its potential influences on therapeutic response and clinical trials underway looking at “a healthy dietary pattern not just for prevention but survival.”
Diet and Probiotics After allo-HSCT
The patterns of microbiota disruption during allo-HSCT — a procedure that includes antibiotic administration, chemotherapy, and sometimes irradiation — are characterized by loss of diversity and the expansion of potentially pathogenic organisms, most commonly Enterococcus, said Peled.
This has been demonstrated across transplantation centers. In a multicenter, international study published in 2020, the patterns of microbiota disruption and their impact on mortality were similar across MSK and other transplantation centers, with higher diversity of intestinal microbiota associated with lower mortality.
Other studies have shown that Enterococcus domination alone (defined arbitrarily as > 30% of fecal microbial composition) is associated with graft vs host disease and higher mortality after allo-HSCT and that intestinal domination by Proteobacteria coincides temporally with BSIs, he said.
Autologous fecal microbiota transplantation (FMT) has been shown to largely restore the microbiota composition the patient had before antibiotic treatment and allo-HSCT, he said, making fecal sample banking and posttreatment FMT a potential approach for reconstituting the gut microbiome and improving outcomes.
But “lately we’ve been very interested in diet for modulating [harmful] patterns” in the microbiome composition, Peled said.
In the new study suggesting a role for sugar avoidance, published last year as a bioRxiv preprint, Peled and his colleagues collected real-time dietary intake data (40,702 food entries) from 173 patients hospitalized for several weeks for allo-HSCT at MSK and analyzed it alongside longitudinally collected fecal samples. They used a Bayesian mixed-effects model to identify dietary components that may correlate with microbial disruption.
“What jumped out as very predictive of a low diversity fecal sample [and expansion of Enterococcus] in the 2 days prior to collection was the interaction between antibiotics and the consumption of sweets” — foods rich in simple sugars, Peled said. The relationship between sugar and the microbiome occurred only during periods of antibiotic exposure.
“And it was particularly perplexing because the foods that fall into the ‘sweets’ category are foods we encourage people to eat clinically when they’re not feeling well and food intake drops dramatically,” he said. This includes foods like nutritional drinks or shakes, Italian ice, gelatin dessert, and sports drinks.
(In a mouse model of post-antibiotic Enterococcus expansion, Peled and his co-investigators then validated the findings and ruled out the impact of any reductions in fiber.)
In addition to possibly revising dietary recommendations for patients undergoing allo-HSCT, the findings raise the question of whether avoiding sugar intake while on antibiotics, in general, is a way to mitigate antibiotic-induced dysbiosis, he said.
To test the role of probiotics, Peled and colleagues collaborated with Seres Therapeutics on a phase 1b trial of an oral combination (SER-155) of 16 fermented strains “selected rationally,” he said, for their ability to decolonize gut pathogens, improve gut barrier function (in vitro), and reduce gut inflammation and local immune activation.
After a safety lead-in, patients were randomized to receive SER-155 (20) or placebo (14) three times — prior to transplant, upon neutrophil engraftment (with vancomycin “conditioning”), and after transplant. “The strains succeeded in grafting in the [gastrointestinal] GI tract…and some of them persisted all the way through to day 100,” Peled said.
The incidence of pathogen domination was substantially lower in the probiotic recipients compared to an MSK historical control cohort, and the incidence of BSIs was significantly lower compared to the placebo arm (10% vs 43%, respectively, representing a 77% relative risk reduction), he said.
Diet and Immunotherapy Response: Trials at MD Anderson
One of the first trials Daniel-MacDougall launched at MD Anderson on diet and the microbiome randomized 55 patients who were obese and had a history of colorectal cancer or precancerous polyps to add a cup of beans to their usual diet or to continue their usual diet without beans. There was a crossover at 8 weeks in the 16-week BE GONE trial; stool and fasting blood were collected every 4 weeks.
“Beans are a prebiotic super-house in my opinion, and they’re also something this population would avoid,” said Daniel-MacDougall, associate professor in the department of epidemiology at MD Anderson and faculty director of the Bionutrition Research Core and Research Kitchen.
“We saw a modest increase in alpha diversity [in the intervention group] and similar trends with microbiota-derived metabolites” that regressed when patients returned to their usual diet, she said. The researchers also documented decreases in proteomic biomarkers of intestinal and systemic immune and inflammatory response.
The impact of diet on cancer survival was shown in subsequent research, including an observational study published in Science in 2021 of patients with melanoma receiving immune checkpoint blockade (ICB) treatment. “Patients who consumed insufficient dietary fiber at the start of therapy tended to do worse [than those reporting sufficient fiber intake],” with significantly lower progression-free survival, Daniel-MacDougall said.
“And interestingly, when we looked at dietary fiber [with and without] probiotic use, patients who had sufficient fiber but did not take probiotics did the best,” she said. [The probiotics were not endorsed or selected by their physicians.]
Now, the researchers at MD Anderson are moving into “precision nutrition” research, Daniel-MacDougall said, with a phase 2 randomized, double-blind trial of high dietary fiber intake (a target of 50 g/d from whole foods) vs a healthy control diet (20 g/d of fiber) in patients with melanoma receiving ICB.
The study, which is underway, is a fully controlled feeding study, with all meals and snacks provided by MD Anderson and macronutrients controlled. Researchers are collecting blood, stool, and tumor tissue (if available) to answer questions about the microbiome, changes in systemic and tissue immunity, disease response and immunotherapy toxicity, and other issues.
Peled disclosed IP licensing and research support from Seres Therapeutics; consulting with Da Volterra, MaaT Pharma, and CSL Behring; and advisory/equity with Postbiotics + Research LLC and Prodigy Biosciences. Daniel-MacDougall reported having no disclosures.
A version of this article appeared on Medscape.com.
Antibiotics Pre-Appendectomy Don’t Lower Perforation Risk, But Reduce Infections
, according to a new study.
While the percentage of surgical site infections (SSIs) was small for both groups, patients who received antibiotics during the waiting period had lower rates of these infections.
The trial — titled PERFECT-Antibiotics — was a substudy embedded in a larger PERFECT clinical trial, which aimed to determine whether an in-hospital delay of appendectomy resulted in increased risk for appendiceal perforation when compared to emergent surgery.
The trial “concluded that appendectomy does not need to be performed promptly in acute uncomplicated appendicitis and can be scheduled within 24 hours without increasing complications,” senior author Panu Mentula, MD, of the Department of Gastroenterological Surgery, Helsinki University Hospital, Helsinki, Finland, and colleagues wrote in the study. “The next question is whether preoperatively started antibiotic treatment reduces the risk of appendiceal perforations.”
The findings were published online in JAMA Surgery on May 14, 2025.
Trial Design
PERFECT-Antibiotics was an open-label, randomized trial conducted at two hospitals in Finland and one hospital in Norway. Researchers enrolled 1774 individuals diagnosed with acute uncomplicated appendicitis, diagnosed clinically or via imaging. Patients were placed in one of two groups: The antibiotic group received intravenous (IV) cefuroxime (1500 mg) and metronidazole (500 mg) every 8 hours until surgery, while the nonantibiotic group waited for surgery without antibiotics.
All patients received one dose of IV cefuroxime (1500 mg) and metronidazole (500 mg) during anesthesia induction. The primary outcome was perforated appendicitis and secondary outcomes included complication rate and SSIs within 30 days of follow-up.
The median age of patients was 35 years (interquartile range [IQR], 28-46 years), and 55% of patients were men. Patients waited a median time of 9 hours (IQR, 4.3-15.5) from study randomization to undergoing surgery.
No Difference in Appendiceal Perforation
Of the 888 patients in the preoperative antibiotic group, 26.2% received one dose, 38.7% received two doses, 22.6% received three doses, and 11.8% received four or more doses of antibiotics, including the antibiotic dose given during anesthesia. A total of 74 patients (8.3%) in this group had a perforated appendix.
Of the 886 patients not given preoperative antibiotics, 79 (8.9%) had a perforated appendix, which met the predetermined noninferiority threshold.
The groups had similar complication rates over the 30-day follow-up, though SSIs were lower in the antibiotic group (1.6%) than the no antibiotic group (3.2%).
The researchers estimated that the number needed to treat for antibiotic therapy was 63 for SSIs, 83 for intra-abdominal SSI, and 125 for reintervention.
“Although longer preoperative antibiotic treatment resulted in slightly lower rate of postoperative infectious complications, the actual difference was very small and probably clinically not significant to justify longer preoperative antibiotic treatment,” Mentula and colleagues wrote.
Lower Infection Rates With Antibiotics
Commenting on the study for GI & Hepatology News, Theodore Pappas, MD, professor of surgery at Duke University School of Medicine in Durham, North Carolina, placed greater importance on these secondary outcomes.
Intra-abdominal infections, a subset of SSIs, were more than twice as common in the no-antibiotic group (1.9%) than in the antibiotic group (0.7%; P = .02). Positive blood cultures were also more common in the no-antibiotic group than the antibiotic group (P = .02).
While the authors qualified these results, “the reality was it was better to use antibiotics,” he said.
There was also a “big overlap between the two groups,” he said, which may have muted differences between the two groups. For example, one fourth of patients in the antibiotic group received only one dose of antibiotics, the same treatment regimen as the no-antibiotic group.
“Although protocol required prophylaxis in all patients in the induction of anesthesia, some clinicians thought that it was unnecessary, because antibiotics had already been given only a couple of hours ago” in patients in the antibiotic group, Mentula told GI & Hepatology News. She did not think that would affect the study’s results.
The PERFECT trial and the antibiotics subtrial answer two important questions that have been asked for years, Pappas continued: Whether appendectomy for uncomplicated acute appendicitis needs to be performed emergently and if antibiotics administered while waiting for surgery improve outcomes.
“Basically, the study shows that you probably should keep them on antibiotics while you’re waiting,” he said.
The study was funded by Finnish Medical Foundation, the Mary and Georg Ehrnrooth Foundation, the Biomedicum Helsinki Foundation, and The Norwegian Surveillance Programme for Antimicrobial Resistance and research funds from the Finnish government. Mentula received grants from the Finnish government during the conduct of the study and personal fees from Pfizer outside the submitted work. Pappas reported no relevant disclosures.
A version of this article appeared on Medscape.com.
, according to a new study.
While the percentage of surgical site infections (SSIs) was small for both groups, patients who received antibiotics during the waiting period had lower rates of these infections.
The trial — titled PERFECT-Antibiotics — was a substudy embedded in a larger PERFECT clinical trial, which aimed to determine whether an in-hospital delay of appendectomy resulted in increased risk for appendiceal perforation when compared to emergent surgery.
The trial “concluded that appendectomy does not need to be performed promptly in acute uncomplicated appendicitis and can be scheduled within 24 hours without increasing complications,” senior author Panu Mentula, MD, of the Department of Gastroenterological Surgery, Helsinki University Hospital, Helsinki, Finland, and colleagues wrote in the study. “The next question is whether preoperatively started antibiotic treatment reduces the risk of appendiceal perforations.”
The findings were published online in JAMA Surgery on May 14, 2025.
Trial Design
PERFECT-Antibiotics was an open-label, randomized trial conducted at two hospitals in Finland and one hospital in Norway. Researchers enrolled 1774 individuals diagnosed with acute uncomplicated appendicitis, diagnosed clinically or via imaging. Patients were placed in one of two groups: The antibiotic group received intravenous (IV) cefuroxime (1500 mg) and metronidazole (500 mg) every 8 hours until surgery, while the nonantibiotic group waited for surgery without antibiotics.
All patients received one dose of IV cefuroxime (1500 mg) and metronidazole (500 mg) during anesthesia induction. The primary outcome was perforated appendicitis and secondary outcomes included complication rate and SSIs within 30 days of follow-up.
The median age of patients was 35 years (interquartile range [IQR], 28-46 years), and 55% of patients were men. Patients waited a median time of 9 hours (IQR, 4.3-15.5) from study randomization to undergoing surgery.
No Difference in Appendiceal Perforation
Of the 888 patients in the preoperative antibiotic group, 26.2% received one dose, 38.7% received two doses, 22.6% received three doses, and 11.8% received four or more doses of antibiotics, including the antibiotic dose given during anesthesia. A total of 74 patients (8.3%) in this group had a perforated appendix.
Of the 886 patients not given preoperative antibiotics, 79 (8.9%) had a perforated appendix, which met the predetermined noninferiority threshold.
The groups had similar complication rates over the 30-day follow-up, though SSIs were lower in the antibiotic group (1.6%) than the no antibiotic group (3.2%).
The researchers estimated that the number needed to treat for antibiotic therapy was 63 for SSIs, 83 for intra-abdominal SSI, and 125 for reintervention.
“Although longer preoperative antibiotic treatment resulted in slightly lower rate of postoperative infectious complications, the actual difference was very small and probably clinically not significant to justify longer preoperative antibiotic treatment,” Mentula and colleagues wrote.
Lower Infection Rates With Antibiotics
Commenting on the study for GI & Hepatology News, Theodore Pappas, MD, professor of surgery at Duke University School of Medicine in Durham, North Carolina, placed greater importance on these secondary outcomes.
Intra-abdominal infections, a subset of SSIs, were more than twice as common in the no-antibiotic group (1.9%) than in the antibiotic group (0.7%; P = .02). Positive blood cultures were also more common in the no-antibiotic group than the antibiotic group (P = .02).
While the authors qualified these results, “the reality was it was better to use antibiotics,” he said.
There was also a “big overlap between the two groups,” he said, which may have muted differences between the two groups. For example, one fourth of patients in the antibiotic group received only one dose of antibiotics, the same treatment regimen as the no-antibiotic group.
“Although protocol required prophylaxis in all patients in the induction of anesthesia, some clinicians thought that it was unnecessary, because antibiotics had already been given only a couple of hours ago” in patients in the antibiotic group, Mentula told GI & Hepatology News. She did not think that would affect the study’s results.
The PERFECT trial and the antibiotics subtrial answer two important questions that have been asked for years, Pappas continued: Whether appendectomy for uncomplicated acute appendicitis needs to be performed emergently and if antibiotics administered while waiting for surgery improve outcomes.
“Basically, the study shows that you probably should keep them on antibiotics while you’re waiting,” he said.
The study was funded by Finnish Medical Foundation, the Mary and Georg Ehrnrooth Foundation, the Biomedicum Helsinki Foundation, and The Norwegian Surveillance Programme for Antimicrobial Resistance and research funds from the Finnish government. Mentula received grants from the Finnish government during the conduct of the study and personal fees from Pfizer outside the submitted work. Pappas reported no relevant disclosures.
A version of this article appeared on Medscape.com.
, according to a new study.
While the percentage of surgical site infections (SSIs) was small for both groups, patients who received antibiotics during the waiting period had lower rates of these infections.
The trial — titled PERFECT-Antibiotics — was a substudy embedded in a larger PERFECT clinical trial, which aimed to determine whether an in-hospital delay of appendectomy resulted in increased risk for appendiceal perforation when compared to emergent surgery.
The trial “concluded that appendectomy does not need to be performed promptly in acute uncomplicated appendicitis and can be scheduled within 24 hours without increasing complications,” senior author Panu Mentula, MD, of the Department of Gastroenterological Surgery, Helsinki University Hospital, Helsinki, Finland, and colleagues wrote in the study. “The next question is whether preoperatively started antibiotic treatment reduces the risk of appendiceal perforations.”
The findings were published online in JAMA Surgery on May 14, 2025.
Trial Design
PERFECT-Antibiotics was an open-label, randomized trial conducted at two hospitals in Finland and one hospital in Norway. Researchers enrolled 1774 individuals diagnosed with acute uncomplicated appendicitis, diagnosed clinically or via imaging. Patients were placed in one of two groups: The antibiotic group received intravenous (IV) cefuroxime (1500 mg) and metronidazole (500 mg) every 8 hours until surgery, while the nonantibiotic group waited for surgery without antibiotics.
All patients received one dose of IV cefuroxime (1500 mg) and metronidazole (500 mg) during anesthesia induction. The primary outcome was perforated appendicitis and secondary outcomes included complication rate and SSIs within 30 days of follow-up.
The median age of patients was 35 years (interquartile range [IQR], 28-46 years), and 55% of patients were men. Patients waited a median time of 9 hours (IQR, 4.3-15.5) from study randomization to undergoing surgery.
No Difference in Appendiceal Perforation
Of the 888 patients in the preoperative antibiotic group, 26.2% received one dose, 38.7% received two doses, 22.6% received three doses, and 11.8% received four or more doses of antibiotics, including the antibiotic dose given during anesthesia. A total of 74 patients (8.3%) in this group had a perforated appendix.
Of the 886 patients not given preoperative antibiotics, 79 (8.9%) had a perforated appendix, which met the predetermined noninferiority threshold.
The groups had similar complication rates over the 30-day follow-up, though SSIs were lower in the antibiotic group (1.6%) than the no antibiotic group (3.2%).
The researchers estimated that the number needed to treat for antibiotic therapy was 63 for SSIs, 83 for intra-abdominal SSI, and 125 for reintervention.
“Although longer preoperative antibiotic treatment resulted in slightly lower rate of postoperative infectious complications, the actual difference was very small and probably clinically not significant to justify longer preoperative antibiotic treatment,” Mentula and colleagues wrote.
Lower Infection Rates With Antibiotics
Commenting on the study for GI & Hepatology News, Theodore Pappas, MD, professor of surgery at Duke University School of Medicine in Durham, North Carolina, placed greater importance on these secondary outcomes.
Intra-abdominal infections, a subset of SSIs, were more than twice as common in the no-antibiotic group (1.9%) than in the antibiotic group (0.7%; P = .02). Positive blood cultures were also more common in the no-antibiotic group than the antibiotic group (P = .02).
While the authors qualified these results, “the reality was it was better to use antibiotics,” he said.
There was also a “big overlap between the two groups,” he said, which may have muted differences between the two groups. For example, one fourth of patients in the antibiotic group received only one dose of antibiotics, the same treatment regimen as the no-antibiotic group.
“Although protocol required prophylaxis in all patients in the induction of anesthesia, some clinicians thought that it was unnecessary, because antibiotics had already been given only a couple of hours ago” in patients in the antibiotic group, Mentula told GI & Hepatology News. She did not think that would affect the study’s results.
The PERFECT trial and the antibiotics subtrial answer two important questions that have been asked for years, Pappas continued: Whether appendectomy for uncomplicated acute appendicitis needs to be performed emergently and if antibiotics administered while waiting for surgery improve outcomes.
“Basically, the study shows that you probably should keep them on antibiotics while you’re waiting,” he said.
The study was funded by Finnish Medical Foundation, the Mary and Georg Ehrnrooth Foundation, the Biomedicum Helsinki Foundation, and The Norwegian Surveillance Programme for Antimicrobial Resistance and research funds from the Finnish government. Mentula received grants from the Finnish government during the conduct of the study and personal fees from Pfizer outside the submitted work. Pappas reported no relevant disclosures.
A version of this article appeared on Medscape.com.
Gut Microbiome Changes in Chronic Pain — Test and Treat?
A new study adds to what has been emerging in the literature — namely that — suggesting that microbiome-based diagnostics and therapeutics may one day be routine for a broad range of pain conditions.
“There is now a whole list of pain conditions that appear to have these signatures, including postoperative pain, arthritis, neuropathy and migraine to name a few,” Robert Bonakdar, MD, director of pain management, Scripps Center for Integrative Medicine, San Diego, told GI & Hepatology News.
Fibromyalgia and complex regional pain syndrome (CRPS) are also on the list.
A team led by Amir Minerbi, MD, PhD, director of the Institute for Pain Medicine, Haifa, Israel, and colleagues published one of the first articles on gut changes in fibromyalgia. They noted that the gut microbiome could be utilized to determine which individuals had the condition and which did not — with about a 90% accuracy.
The team went on to show that transplanting gut microbiota from patients with fibromyalgia into germ-free mice was sufficient to induce pain-like behaviors in the animals — “effects that were reversed when healthy human microbiota were transplanted instead,” Minerbi told GI & Hepatology News.
Further, in a pilot clinical study, the researchers showed that transplanting microbiota from healthy donors led to a reduction in pain and other symptoms in women with treatment-resistant fibromyalgia.
Most recently, they found significant differences in the composition of the gut microbiome in a cohort of patients with CRPS from Israel, compared to matched pain-free control individuals.
Notably, two species — Dialister succinatiphilus and Phascolarctobacterium faecium – were enriched in patients with CRPS, while three species — Ligilactobacillus salivarius, Bifidobacterium dentium, and Bifidobacterium adolescentis – were increased in control samples, according to their report published last month in Anesthesiology.
“Importantly,” these findings were replicated in an independent cohort of patients with CRPS from Canada, “suggesting that the observed microbiome signature is robust and consistent across different environments,” Minerbi told GI & Hepatology News.
Causal Role?
“These findings collectively suggest a causal role for the gut microbiome in at least some chronic pain conditions,” Minerbi said.
However, the co-authors of a linked editorial cautioned that it’s “unclear if D succinatiphilus or P faecium are functionally relevant to CRPS pathophysiology or if the bacteria increased in healthy control samples protect against CRPS development.”
Minerbi and colleagues also observed that fecal concentrations of all measured short chain fatty acids (SCFA) in patients with CRPS were lower on average compared to pain-free control individuals, of which butyric, hexanoic, and valeric acid showed significant depletion.
Additionally, plasma concentrations of acetic acid showed significant depletion in patients with CRPS vs control individuals, while propionate, butyrate, isobutyrate and 2-methyl-butyric acid showed a trend toward lower concentrations.
The quantification of SCFA in patient stool and serum is a “notable advance” in this study, Zulmary Manjarres, PhD; Ashley Plumb, PhD; and Katelyn Sadler, PhD; with the Center for Advanced Pain Studies at The University of Texas at Dallas, wrote in their editorial.
SCFA are produced by bacteria as a byproduct of dietary fiber fermentation and appropriate levels of these compounds are important to maintain low levels of inflammation in the colon and overall gut health, they explained.
This begs the question of whether administering probiotic bacteria — many of which are believed to exert health benefits through SCFA production — can be used to treat CRPS-associated pain. It’s something that needs to be studied, the editorialists wrote.
Yet, in their view, the “most notable achievement” of Minerbi and colleagues is the development of a machine learning model that accurately, specifically and sensitively categorized individuals as patients with CRPS or control individuals based on their fecal microbiome signature.
The model, trained on exact sequence variant data from the Israeli patients, achieved 89.5% accuracy, 90.0% sensitivity, and 88.9% specificity in distinguishing patients with CRPS from control individuals in the Canadian cohort.
Interestingly, in three patients with CRPS who underwent limb amputation and recovered from their pain, their gut microbiome signature remained unchanged, suggesting that microbiome alterations might precede or persist beyond symptomatic phases.
Test and Treat: Are We There Yet?
The gut microbiome link to chronic pain syndromes is a hot area of research, but for now gut microbial testing followed by treatment aimed at “fixing” the microbiome remains largely experimental.
At this point, comprehensive gut-microbiome sequencing is not a routine, guideline-supported part of care for fibromyalgia or any chronic pain condition.
“Unfortunately, even for doctors interested in this area, we are not quite at the state of being able to diagnose and treat pain syndrome based on microbiome data,” Bonakdar told GI & Hepatology News.
He said there are many reasons for this including that this type of microbiome analysis is not commonly available at a routine lab. If patients do obtain testing, then the results are quite complex and may not translate to a diagnosis or a simple microbiome intervention.
“I think the closest option we have now is considering supplementing with commonly beneficial probiotic in pain conditions,” Bonakdar said.
One example is a preliminary fibromyalgia trial which found that supplementing with Lactobacillus, Bifidobacterium, and Saccharomyces boulardii appeared to have benefit.
“Unfortunately, this is hit or miss as other trials such as one in low back pain did not find benefit,” Bonakdar said.
Addressing gut microbiome changes will become “more actionable when microbiome analysis is more commonplace as well as is the ability to tailor treatment to the abnormalities seen on testing in a real-world manner,” Bonakdar said.
“Until then, there is no harm in promoting an anti-inflammatory diet for our patients with pain which we know can improve components of the microbiome while also supporting pain management,” he concluded.
Minerbi, Bonakdar, and the editorial writers had no relevant disclosures.
A version of this article appeared on Medscape.com.
A new study adds to what has been emerging in the literature — namely that — suggesting that microbiome-based diagnostics and therapeutics may one day be routine for a broad range of pain conditions.
“There is now a whole list of pain conditions that appear to have these signatures, including postoperative pain, arthritis, neuropathy and migraine to name a few,” Robert Bonakdar, MD, director of pain management, Scripps Center for Integrative Medicine, San Diego, told GI & Hepatology News.
Fibromyalgia and complex regional pain syndrome (CRPS) are also on the list.
A team led by Amir Minerbi, MD, PhD, director of the Institute for Pain Medicine, Haifa, Israel, and colleagues published one of the first articles on gut changes in fibromyalgia. They noted that the gut microbiome could be utilized to determine which individuals had the condition and which did not — with about a 90% accuracy.
The team went on to show that transplanting gut microbiota from patients with fibromyalgia into germ-free mice was sufficient to induce pain-like behaviors in the animals — “effects that were reversed when healthy human microbiota were transplanted instead,” Minerbi told GI & Hepatology News.
Further, in a pilot clinical study, the researchers showed that transplanting microbiota from healthy donors led to a reduction in pain and other symptoms in women with treatment-resistant fibromyalgia.
Most recently, they found significant differences in the composition of the gut microbiome in a cohort of patients with CRPS from Israel, compared to matched pain-free control individuals.
Notably, two species — Dialister succinatiphilus and Phascolarctobacterium faecium – were enriched in patients with CRPS, while three species — Ligilactobacillus salivarius, Bifidobacterium dentium, and Bifidobacterium adolescentis – were increased in control samples, according to their report published last month in Anesthesiology.
“Importantly,” these findings were replicated in an independent cohort of patients with CRPS from Canada, “suggesting that the observed microbiome signature is robust and consistent across different environments,” Minerbi told GI & Hepatology News.
Causal Role?
“These findings collectively suggest a causal role for the gut microbiome in at least some chronic pain conditions,” Minerbi said.
However, the co-authors of a linked editorial cautioned that it’s “unclear if D succinatiphilus or P faecium are functionally relevant to CRPS pathophysiology or if the bacteria increased in healthy control samples protect against CRPS development.”
Minerbi and colleagues also observed that fecal concentrations of all measured short chain fatty acids (SCFA) in patients with CRPS were lower on average compared to pain-free control individuals, of which butyric, hexanoic, and valeric acid showed significant depletion.
Additionally, plasma concentrations of acetic acid showed significant depletion in patients with CRPS vs control individuals, while propionate, butyrate, isobutyrate and 2-methyl-butyric acid showed a trend toward lower concentrations.
The quantification of SCFA in patient stool and serum is a “notable advance” in this study, Zulmary Manjarres, PhD; Ashley Plumb, PhD; and Katelyn Sadler, PhD; with the Center for Advanced Pain Studies at The University of Texas at Dallas, wrote in their editorial.
SCFA are produced by bacteria as a byproduct of dietary fiber fermentation and appropriate levels of these compounds are important to maintain low levels of inflammation in the colon and overall gut health, they explained.
This begs the question of whether administering probiotic bacteria — many of which are believed to exert health benefits through SCFA production — can be used to treat CRPS-associated pain. It’s something that needs to be studied, the editorialists wrote.
Yet, in their view, the “most notable achievement” of Minerbi and colleagues is the development of a machine learning model that accurately, specifically and sensitively categorized individuals as patients with CRPS or control individuals based on their fecal microbiome signature.
The model, trained on exact sequence variant data from the Israeli patients, achieved 89.5% accuracy, 90.0% sensitivity, and 88.9% specificity in distinguishing patients with CRPS from control individuals in the Canadian cohort.
Interestingly, in three patients with CRPS who underwent limb amputation and recovered from their pain, their gut microbiome signature remained unchanged, suggesting that microbiome alterations might precede or persist beyond symptomatic phases.
Test and Treat: Are We There Yet?
The gut microbiome link to chronic pain syndromes is a hot area of research, but for now gut microbial testing followed by treatment aimed at “fixing” the microbiome remains largely experimental.
At this point, comprehensive gut-microbiome sequencing is not a routine, guideline-supported part of care for fibromyalgia or any chronic pain condition.
“Unfortunately, even for doctors interested in this area, we are not quite at the state of being able to diagnose and treat pain syndrome based on microbiome data,” Bonakdar told GI & Hepatology News.
He said there are many reasons for this including that this type of microbiome analysis is not commonly available at a routine lab. If patients do obtain testing, then the results are quite complex and may not translate to a diagnosis or a simple microbiome intervention.
“I think the closest option we have now is considering supplementing with commonly beneficial probiotic in pain conditions,” Bonakdar said.
One example is a preliminary fibromyalgia trial which found that supplementing with Lactobacillus, Bifidobacterium, and Saccharomyces boulardii appeared to have benefit.
“Unfortunately, this is hit or miss as other trials such as one in low back pain did not find benefit,” Bonakdar said.
Addressing gut microbiome changes will become “more actionable when microbiome analysis is more commonplace as well as is the ability to tailor treatment to the abnormalities seen on testing in a real-world manner,” Bonakdar said.
“Until then, there is no harm in promoting an anti-inflammatory diet for our patients with pain which we know can improve components of the microbiome while also supporting pain management,” he concluded.
Minerbi, Bonakdar, and the editorial writers had no relevant disclosures.
A version of this article appeared on Medscape.com.
A new study adds to what has been emerging in the literature — namely that — suggesting that microbiome-based diagnostics and therapeutics may one day be routine for a broad range of pain conditions.
“There is now a whole list of pain conditions that appear to have these signatures, including postoperative pain, arthritis, neuropathy and migraine to name a few,” Robert Bonakdar, MD, director of pain management, Scripps Center for Integrative Medicine, San Diego, told GI & Hepatology News.
Fibromyalgia and complex regional pain syndrome (CRPS) are also on the list.
A team led by Amir Minerbi, MD, PhD, director of the Institute for Pain Medicine, Haifa, Israel, and colleagues published one of the first articles on gut changes in fibromyalgia. They noted that the gut microbiome could be utilized to determine which individuals had the condition and which did not — with about a 90% accuracy.
The team went on to show that transplanting gut microbiota from patients with fibromyalgia into germ-free mice was sufficient to induce pain-like behaviors in the animals — “effects that were reversed when healthy human microbiota were transplanted instead,” Minerbi told GI & Hepatology News.
Further, in a pilot clinical study, the researchers showed that transplanting microbiota from healthy donors led to a reduction in pain and other symptoms in women with treatment-resistant fibromyalgia.
Most recently, they found significant differences in the composition of the gut microbiome in a cohort of patients with CRPS from Israel, compared to matched pain-free control individuals.
Notably, two species — Dialister succinatiphilus and Phascolarctobacterium faecium – were enriched in patients with CRPS, while three species — Ligilactobacillus salivarius, Bifidobacterium dentium, and Bifidobacterium adolescentis – were increased in control samples, according to their report published last month in Anesthesiology.
“Importantly,” these findings were replicated in an independent cohort of patients with CRPS from Canada, “suggesting that the observed microbiome signature is robust and consistent across different environments,” Minerbi told GI & Hepatology News.
Causal Role?
“These findings collectively suggest a causal role for the gut microbiome in at least some chronic pain conditions,” Minerbi said.
However, the co-authors of a linked editorial cautioned that it’s “unclear if D succinatiphilus or P faecium are functionally relevant to CRPS pathophysiology or if the bacteria increased in healthy control samples protect against CRPS development.”
Minerbi and colleagues also observed that fecal concentrations of all measured short chain fatty acids (SCFA) in patients with CRPS were lower on average compared to pain-free control individuals, of which butyric, hexanoic, and valeric acid showed significant depletion.
Additionally, plasma concentrations of acetic acid showed significant depletion in patients with CRPS vs control individuals, while propionate, butyrate, isobutyrate and 2-methyl-butyric acid showed a trend toward lower concentrations.
The quantification of SCFA in patient stool and serum is a “notable advance” in this study, Zulmary Manjarres, PhD; Ashley Plumb, PhD; and Katelyn Sadler, PhD; with the Center for Advanced Pain Studies at The University of Texas at Dallas, wrote in their editorial.
SCFA are produced by bacteria as a byproduct of dietary fiber fermentation and appropriate levels of these compounds are important to maintain low levels of inflammation in the colon and overall gut health, they explained.
This begs the question of whether administering probiotic bacteria — many of which are believed to exert health benefits through SCFA production — can be used to treat CRPS-associated pain. It’s something that needs to be studied, the editorialists wrote.
Yet, in their view, the “most notable achievement” of Minerbi and colleagues is the development of a machine learning model that accurately, specifically and sensitively categorized individuals as patients with CRPS or control individuals based on their fecal microbiome signature.
The model, trained on exact sequence variant data from the Israeli patients, achieved 89.5% accuracy, 90.0% sensitivity, and 88.9% specificity in distinguishing patients with CRPS from control individuals in the Canadian cohort.
Interestingly, in three patients with CRPS who underwent limb amputation and recovered from their pain, their gut microbiome signature remained unchanged, suggesting that microbiome alterations might precede or persist beyond symptomatic phases.
Test and Treat: Are We There Yet?
The gut microbiome link to chronic pain syndromes is a hot area of research, but for now gut microbial testing followed by treatment aimed at “fixing” the microbiome remains largely experimental.
At this point, comprehensive gut-microbiome sequencing is not a routine, guideline-supported part of care for fibromyalgia or any chronic pain condition.
“Unfortunately, even for doctors interested in this area, we are not quite at the state of being able to diagnose and treat pain syndrome based on microbiome data,” Bonakdar told GI & Hepatology News.
He said there are many reasons for this including that this type of microbiome analysis is not commonly available at a routine lab. If patients do obtain testing, then the results are quite complex and may not translate to a diagnosis or a simple microbiome intervention.
“I think the closest option we have now is considering supplementing with commonly beneficial probiotic in pain conditions,” Bonakdar said.
One example is a preliminary fibromyalgia trial which found that supplementing with Lactobacillus, Bifidobacterium, and Saccharomyces boulardii appeared to have benefit.
“Unfortunately, this is hit or miss as other trials such as one in low back pain did not find benefit,” Bonakdar said.
Addressing gut microbiome changes will become “more actionable when microbiome analysis is more commonplace as well as is the ability to tailor treatment to the abnormalities seen on testing in a real-world manner,” Bonakdar said.
“Until then, there is no harm in promoting an anti-inflammatory diet for our patients with pain which we know can improve components of the microbiome while also supporting pain management,” he concluded.
Minerbi, Bonakdar, and the editorial writers had no relevant disclosures.
A version of this article appeared on Medscape.com.
Journal Highlights: January-April 2025
Esophagus/Motility
Carlson DA, et al. A Standardized Approach to Performing and Interpreting Functional Lumen Imaging Probe Panometry for Esophageal Motility Disorders: The Dallas Consensus. Gastroenterology. 2025 Feb. doi: 10.1053/j.gastro.2025.01.234.
Parkman HP, et al; NIDDK Gastroparesis Clinical Research Consortium. Characterization of Patients with Symptoms of Gastroparesis Having Frequent Emergency Department Visits and Hospitalizations. Clin Gastroenterol Hepatol. 2025 Apr. doi: 10.1016/j.cgh.2025.01.033.
Dellon ES, et al. Long-term Safety and Efficacy of Budesonide Oral Suspension for Eosinophilic Esophagitis: A 4-Year, Phase 3, Open-Label Study. Clin Gastroenterol Hepatol. 2025 Feb. doi: 10.1016/j.cgh.2024.12.024.
Small Bowel
Hård Af Segerstad EM, et al; TEDDY Study Group. Early Dietary Fiber Intake Reduces Celiac Disease Risk in Genetically Prone Children: Insights From the TEDDY Study. Gastroenterology. 2025 Feb. doi: 10.1053/j.gastro.2025.01.241.
Colon
Shaukat A, et al. AGA Clinical Practice Update on Current Role of Blood Tests for Colorectal Cancer Screening: Commentary. Clin Gastroenterol Hepatol. 2025 Apr. doi: 10.1016/j.cgh.2025.04.003.
Bergman D, et al. Cholecystectomy is a Risk Factor for Microscopic Colitis: A Nationwide Population-based Matched Case Control Study. Clin Gastroenterol Hepatol. 2025 Mar. doi: 10.1016/j.cgh.2024.12.032.
Inflammatory Bowel Disease
Ben-Horin S, et al; Israeli IBD Research Nucleus (IIRN). Capsule Endoscopy-Guided Proactive Treat-to-Target Versus Continued Standard Care in Patients With Quiescent Crohn’s Disease: A Randomized Controlled Trial. Gastroenterology. 2025 Mar. doi: 10.1053/j.gastro.2025.02.031.
Pancreas
Guilabert L, et al; ERICA Consortium. Impact of Fluid Therapy in the Emergency Department in Acute Pancreatitis: a posthoc analysis of the WATERFALL Trial. Clin Gastroenterol Hepatol. 2025 Apr. doi: 10.1016/j.cgh.2025.01.038.
Hepatology
Rhee H, et al. Noncontrast Magnetic Resonance Imaging vs Ultrasonography for Hepatocellular Carcinoma Surveillance: A Randomized, Single-Center Trial. Gastroenterology. 2025 Jan. doi: 10.1053/j.gastro.2024.12.035.
Kronsten VT, et al. Hepatic Encephalopathy: When Lactulose and Rifaximin Are Not Working. Gastroenterology. 2025 Jan. doi: 10.1053/j.gastro.2025.01.010.
Edelson JC, et al. Accuracy and Safety of Endoscopic Ultrasound–Guided Liver Biopsy in Patients with Metabolic Dysfunction–Associated Liver Disease. Tech Innov Gastrointest Endosc. 2025 Apr. doi: 10.1016/j.tige.2025.250918.
Miscellaneous
Martin J, et al. Practical and Impactful Tips for Private Industry Collaborations with Gastroenterology Practices. Clin Gastroenterol Hepatol. 2025 Mar. doi: 10.1016/j.cgh.2025.01.021.
Tejada, Natalia et al. Glucagon-like Peptide-1 Receptor Agonists Are Not Associated With Increased Incidence of Pneumonia After Endoscopic Procedures. Tech Innov Gastrointest Endosc. 2025 Apr. doi: 10.1016/j.tige.2025.250925.
Lazaridis KN, et al. Microplastics and Nanoplastics and the Digestive System. Gastro Hep Adv. 2025 May. doi: 10.1016/j.gastha.2025.100694.
Dr. Trieu is assistant professor of medicine, interventional endoscopy, in the Division of Gastroenterology at Washington University in St. Louis School of Medicine, Missouri.
Esophagus/Motility
Carlson DA, et al. A Standardized Approach to Performing and Interpreting Functional Lumen Imaging Probe Panometry for Esophageal Motility Disorders: The Dallas Consensus. Gastroenterology. 2025 Feb. doi: 10.1053/j.gastro.2025.01.234.
Parkman HP, et al; NIDDK Gastroparesis Clinical Research Consortium. Characterization of Patients with Symptoms of Gastroparesis Having Frequent Emergency Department Visits and Hospitalizations. Clin Gastroenterol Hepatol. 2025 Apr. doi: 10.1016/j.cgh.2025.01.033.
Dellon ES, et al. Long-term Safety and Efficacy of Budesonide Oral Suspension for Eosinophilic Esophagitis: A 4-Year, Phase 3, Open-Label Study. Clin Gastroenterol Hepatol. 2025 Feb. doi: 10.1016/j.cgh.2024.12.024.
Small Bowel
Hård Af Segerstad EM, et al; TEDDY Study Group. Early Dietary Fiber Intake Reduces Celiac Disease Risk in Genetically Prone Children: Insights From the TEDDY Study. Gastroenterology. 2025 Feb. doi: 10.1053/j.gastro.2025.01.241.
Colon
Shaukat A, et al. AGA Clinical Practice Update on Current Role of Blood Tests for Colorectal Cancer Screening: Commentary. Clin Gastroenterol Hepatol. 2025 Apr. doi: 10.1016/j.cgh.2025.04.003.
Bergman D, et al. Cholecystectomy is a Risk Factor for Microscopic Colitis: A Nationwide Population-based Matched Case Control Study. Clin Gastroenterol Hepatol. 2025 Mar. doi: 10.1016/j.cgh.2024.12.032.
Inflammatory Bowel Disease
Ben-Horin S, et al; Israeli IBD Research Nucleus (IIRN). Capsule Endoscopy-Guided Proactive Treat-to-Target Versus Continued Standard Care in Patients With Quiescent Crohn’s Disease: A Randomized Controlled Trial. Gastroenterology. 2025 Mar. doi: 10.1053/j.gastro.2025.02.031.
Pancreas
Guilabert L, et al; ERICA Consortium. Impact of Fluid Therapy in the Emergency Department in Acute Pancreatitis: a posthoc analysis of the WATERFALL Trial. Clin Gastroenterol Hepatol. 2025 Apr. doi: 10.1016/j.cgh.2025.01.038.
Hepatology
Rhee H, et al. Noncontrast Magnetic Resonance Imaging vs Ultrasonography for Hepatocellular Carcinoma Surveillance: A Randomized, Single-Center Trial. Gastroenterology. 2025 Jan. doi: 10.1053/j.gastro.2024.12.035.
Kronsten VT, et al. Hepatic Encephalopathy: When Lactulose and Rifaximin Are Not Working. Gastroenterology. 2025 Jan. doi: 10.1053/j.gastro.2025.01.010.
Edelson JC, et al. Accuracy and Safety of Endoscopic Ultrasound–Guided Liver Biopsy in Patients with Metabolic Dysfunction–Associated Liver Disease. Tech Innov Gastrointest Endosc. 2025 Apr. doi: 10.1016/j.tige.2025.250918.
Miscellaneous
Martin J, et al. Practical and Impactful Tips for Private Industry Collaborations with Gastroenterology Practices. Clin Gastroenterol Hepatol. 2025 Mar. doi: 10.1016/j.cgh.2025.01.021.
Tejada, Natalia et al. Glucagon-like Peptide-1 Receptor Agonists Are Not Associated With Increased Incidence of Pneumonia After Endoscopic Procedures. Tech Innov Gastrointest Endosc. 2025 Apr. doi: 10.1016/j.tige.2025.250925.
Lazaridis KN, et al. Microplastics and Nanoplastics and the Digestive System. Gastro Hep Adv. 2025 May. doi: 10.1016/j.gastha.2025.100694.
Dr. Trieu is assistant professor of medicine, interventional endoscopy, in the Division of Gastroenterology at Washington University in St. Louis School of Medicine, Missouri.
Esophagus/Motility
Carlson DA, et al. A Standardized Approach to Performing and Interpreting Functional Lumen Imaging Probe Panometry for Esophageal Motility Disorders: The Dallas Consensus. Gastroenterology. 2025 Feb. doi: 10.1053/j.gastro.2025.01.234.
Parkman HP, et al; NIDDK Gastroparesis Clinical Research Consortium. Characterization of Patients with Symptoms of Gastroparesis Having Frequent Emergency Department Visits and Hospitalizations. Clin Gastroenterol Hepatol. 2025 Apr. doi: 10.1016/j.cgh.2025.01.033.
Dellon ES, et al. Long-term Safety and Efficacy of Budesonide Oral Suspension for Eosinophilic Esophagitis: A 4-Year, Phase 3, Open-Label Study. Clin Gastroenterol Hepatol. 2025 Feb. doi: 10.1016/j.cgh.2024.12.024.
Small Bowel
Hård Af Segerstad EM, et al; TEDDY Study Group. Early Dietary Fiber Intake Reduces Celiac Disease Risk in Genetically Prone Children: Insights From the TEDDY Study. Gastroenterology. 2025 Feb. doi: 10.1053/j.gastro.2025.01.241.
Colon
Shaukat A, et al. AGA Clinical Practice Update on Current Role of Blood Tests for Colorectal Cancer Screening: Commentary. Clin Gastroenterol Hepatol. 2025 Apr. doi: 10.1016/j.cgh.2025.04.003.
Bergman D, et al. Cholecystectomy is a Risk Factor for Microscopic Colitis: A Nationwide Population-based Matched Case Control Study. Clin Gastroenterol Hepatol. 2025 Mar. doi: 10.1016/j.cgh.2024.12.032.
Inflammatory Bowel Disease
Ben-Horin S, et al; Israeli IBD Research Nucleus (IIRN). Capsule Endoscopy-Guided Proactive Treat-to-Target Versus Continued Standard Care in Patients With Quiescent Crohn’s Disease: A Randomized Controlled Trial. Gastroenterology. 2025 Mar. doi: 10.1053/j.gastro.2025.02.031.
Pancreas
Guilabert L, et al; ERICA Consortium. Impact of Fluid Therapy in the Emergency Department in Acute Pancreatitis: a posthoc analysis of the WATERFALL Trial. Clin Gastroenterol Hepatol. 2025 Apr. doi: 10.1016/j.cgh.2025.01.038.
Hepatology
Rhee H, et al. Noncontrast Magnetic Resonance Imaging vs Ultrasonography for Hepatocellular Carcinoma Surveillance: A Randomized, Single-Center Trial. Gastroenterology. 2025 Jan. doi: 10.1053/j.gastro.2024.12.035.
Kronsten VT, et al. Hepatic Encephalopathy: When Lactulose and Rifaximin Are Not Working. Gastroenterology. 2025 Jan. doi: 10.1053/j.gastro.2025.01.010.
Edelson JC, et al. Accuracy and Safety of Endoscopic Ultrasound–Guided Liver Biopsy in Patients with Metabolic Dysfunction–Associated Liver Disease. Tech Innov Gastrointest Endosc. 2025 Apr. doi: 10.1016/j.tige.2025.250918.
Miscellaneous
Martin J, et al. Practical and Impactful Tips for Private Industry Collaborations with Gastroenterology Practices. Clin Gastroenterol Hepatol. 2025 Mar. doi: 10.1016/j.cgh.2025.01.021.
Tejada, Natalia et al. Glucagon-like Peptide-1 Receptor Agonists Are Not Associated With Increased Incidence of Pneumonia After Endoscopic Procedures. Tech Innov Gastrointest Endosc. 2025 Apr. doi: 10.1016/j.tige.2025.250925.
Lazaridis KN, et al. Microplastics and Nanoplastics and the Digestive System. Gastro Hep Adv. 2025 May. doi: 10.1016/j.gastha.2025.100694.
Dr. Trieu is assistant professor of medicine, interventional endoscopy, in the Division of Gastroenterology at Washington University in St. Louis School of Medicine, Missouri.
Video Capsule Endoscopy Aids Targeted Treatment in Quiescent Crohn’s
A treat-to target (T2T) strategy based on video capsule endoscopy (VCE) identified Crohn’s disease (CD) patients in clinical remission but with small bowel inflammation, resulting in fewer clinical flares versus a treat-by-symptoms standard approach.
“A VCE-guided treat-to-target strategy for patients with CD in remission confers superior clinical outcomes compared with continued standard care,” investigators led by Shomron Ben-Horin, MD, director of gastroenterology at Sheba Medical Center in Ramat-Gan, Israel.
Published in Gastroenterology, the CURE-CD (Comprehensive Individualized Proactive Therapy of Crohn’s Disease), a prospective, temporally blinded, randomized controled trial, looked at 60 adult patients with quiescent CD involving the small bowel (either L1 or L3 iof the terminal ileum and upper colon).
The researchers defined quiescent disease as corticosteroid-free clinical remission with a Crohn’s Disease Activity Index (CDAI) of <50 for the past 3 months on a stable regimen.
Patients ingested a VCE at baseline and those with a Lewis inflammatory score (LS) of ≥350 were designated high risk (n = 40) and randomized to either T2T optimization (n = 20) or continuing standard care (n = 20).
T2T was optimized with repeat VCE results every 6 months. Patients with LS <350 (“low risk”) continued standard care. The primary outcome was the rate of disease exacerbation, demonstrated by a CDAI increase of >70 points and a score >150, or hospitalization/surgery, in high-risk standard care vs T2T groups at 24 months.
Treatment intensification in the high-risk group allocated to a proactive strategy comprised biologic dose escalation (n = 11 of 20), starting a biologic (n = 8 of 20), or swapping biologics (n = 1 of 20).
The primary outcome, clinical flare by 24 months, occurred in 5 of 20 (25%) of high-risk treat-to-target patients vs 14 of 20 (70%) of the high-risk standard-care group (odds ratio [OR], .14; 95% confidence interval [CI], .04–.57, P = .006).
Mucosal healing was significantly more common in the T2T group when determined by a cutoff LS < 350 (OR, 4.5, 95% CI, 1.7–17.4, nominal P value = .03), but not by the combined scores of total LS < 450 and highest-segment LS < 350.
Among all patients continuing standard care (n = 40), baseline LS was numerically higher among relapsers vs nonrelapsers (450, 225–900 vs 225, 135–600, respectively, P = .07).
As to safety, of 221 VCEs ingested, there was a single (.4%) temporary retention, which spontaneously resolved.
“VCE monitoring of CD was approved into government reimbursement in Israel last year, and I know several European countries are also considering the inclusion of this new indication for VCE in their payer reimbursement,” Ben-Horin told GI & Hepatology News. “Uptake in Israel is still baby-stepping. In our center it’s much more common to monitor T2T for small bowel patients, but this approach is still not widely applied.”
The authors cautioned that since the focus was the small bowel, the findings are not necessarily generalizable to patients with Crohn’s colitis.
The study was supported by the Leona M. & Harry B. Helmsley Charitable Trust, Medtronic (USA), AbbVie (Israel), and Takeda. The funders did not intervene in the design or interpretation of the study.
Ben-Horin reported advisory, consulting fees, research support, and/or stocks/options from several pharmaceutical firms. Several coauthors disclosed similar relations with private-sector companies.
As treat-to-target (T2T) strategies continue to redefine inflammatory bowel disease (IBD) care, this randomized controlled trial by Ben-Horin et al. highlights the value of proactive video capsule endoscopy (VCE) monitoring in patients with quiescent small bowel Crohn’s disease (CD).
The study demonstrated that scheduled VCE every six months, used to guide treatment adjustments, significantly reduced clinical flares over 24 months compared to symptom-based standard care. While differences in mucosal healing between groups were less pronounced, the results underscore that monitoring objective inflammation, even in asymptomatic patients, can improve clinical outcomes.
In clinical practice, symptom-driven management remains common, often due to limited access to endoscopy or patient hesitancy toward invasive procedures. VCE offers a non-invasive, well-tolerated alternative that may improve patient adherence to disease monitoring, particularly in small bowel CD. This approach addresses a significant gap in care, as nearly half of IBD patients do not undergo objective disease assessment within a year of starting biologics.
Clinicians should consider integrating VCE into individualized T2T strategies, especially in settings where endoscopic access is constrained. Furthermore, adjunctive non-invasive tools such as intestinal ultrasound (IUS) with biomarkers could further support a non-invasive, patient-centered monitoring approach. As the definition of remission evolves toward more ambitious targets like transmural healing, the integration of cross-sectional imaging modalities such as IUS into routine monitoring protocols may become essential. Aligning monitoring techniques with evolving therapeutic targets and patient preferences will be key to optimizing long-term disease control in CD.
Mariangela Allocca, MD, PhD, is head of the IBD Center at IRCCS Hospital San Raffaele, and professor of gastroenterology at Vita-Salute San Raffaele University, both in Milan, Italy. Silvio Danese, MD, PhD, is professor of gastroenterology at Vita-Salute San Raffaele University and IRCCS San Raffaele Hospital, Milan. Both authors report consulting and/or speaking fees from multiple drug and device companies.
As treat-to-target (T2T) strategies continue to redefine inflammatory bowel disease (IBD) care, this randomized controlled trial by Ben-Horin et al. highlights the value of proactive video capsule endoscopy (VCE) monitoring in patients with quiescent small bowel Crohn’s disease (CD).
The study demonstrated that scheduled VCE every six months, used to guide treatment adjustments, significantly reduced clinical flares over 24 months compared to symptom-based standard care. While differences in mucosal healing between groups were less pronounced, the results underscore that monitoring objective inflammation, even in asymptomatic patients, can improve clinical outcomes.
In clinical practice, symptom-driven management remains common, often due to limited access to endoscopy or patient hesitancy toward invasive procedures. VCE offers a non-invasive, well-tolerated alternative that may improve patient adherence to disease monitoring, particularly in small bowel CD. This approach addresses a significant gap in care, as nearly half of IBD patients do not undergo objective disease assessment within a year of starting biologics.
Clinicians should consider integrating VCE into individualized T2T strategies, especially in settings where endoscopic access is constrained. Furthermore, adjunctive non-invasive tools such as intestinal ultrasound (IUS) with biomarkers could further support a non-invasive, patient-centered monitoring approach. As the definition of remission evolves toward more ambitious targets like transmural healing, the integration of cross-sectional imaging modalities such as IUS into routine monitoring protocols may become essential. Aligning monitoring techniques with evolving therapeutic targets and patient preferences will be key to optimizing long-term disease control in CD.
Mariangela Allocca, MD, PhD, is head of the IBD Center at IRCCS Hospital San Raffaele, and professor of gastroenterology at Vita-Salute San Raffaele University, both in Milan, Italy. Silvio Danese, MD, PhD, is professor of gastroenterology at Vita-Salute San Raffaele University and IRCCS San Raffaele Hospital, Milan. Both authors report consulting and/or speaking fees from multiple drug and device companies.
As treat-to-target (T2T) strategies continue to redefine inflammatory bowel disease (IBD) care, this randomized controlled trial by Ben-Horin et al. highlights the value of proactive video capsule endoscopy (VCE) monitoring in patients with quiescent small bowel Crohn’s disease (CD).
The study demonstrated that scheduled VCE every six months, used to guide treatment adjustments, significantly reduced clinical flares over 24 months compared to symptom-based standard care. While differences in mucosal healing between groups were less pronounced, the results underscore that monitoring objective inflammation, even in asymptomatic patients, can improve clinical outcomes.
In clinical practice, symptom-driven management remains common, often due to limited access to endoscopy or patient hesitancy toward invasive procedures. VCE offers a non-invasive, well-tolerated alternative that may improve patient adherence to disease monitoring, particularly in small bowel CD. This approach addresses a significant gap in care, as nearly half of IBD patients do not undergo objective disease assessment within a year of starting biologics.
Clinicians should consider integrating VCE into individualized T2T strategies, especially in settings where endoscopic access is constrained. Furthermore, adjunctive non-invasive tools such as intestinal ultrasound (IUS) with biomarkers could further support a non-invasive, patient-centered monitoring approach. As the definition of remission evolves toward more ambitious targets like transmural healing, the integration of cross-sectional imaging modalities such as IUS into routine monitoring protocols may become essential. Aligning monitoring techniques with evolving therapeutic targets and patient preferences will be key to optimizing long-term disease control in CD.
Mariangela Allocca, MD, PhD, is head of the IBD Center at IRCCS Hospital San Raffaele, and professor of gastroenterology at Vita-Salute San Raffaele University, both in Milan, Italy. Silvio Danese, MD, PhD, is professor of gastroenterology at Vita-Salute San Raffaele University and IRCCS San Raffaele Hospital, Milan. Both authors report consulting and/or speaking fees from multiple drug and device companies.
A treat-to target (T2T) strategy based on video capsule endoscopy (VCE) identified Crohn’s disease (CD) patients in clinical remission but with small bowel inflammation, resulting in fewer clinical flares versus a treat-by-symptoms standard approach.
“A VCE-guided treat-to-target strategy for patients with CD in remission confers superior clinical outcomes compared with continued standard care,” investigators led by Shomron Ben-Horin, MD, director of gastroenterology at Sheba Medical Center in Ramat-Gan, Israel.
Published in Gastroenterology, the CURE-CD (Comprehensive Individualized Proactive Therapy of Crohn’s Disease), a prospective, temporally blinded, randomized controled trial, looked at 60 adult patients with quiescent CD involving the small bowel (either L1 or L3 iof the terminal ileum and upper colon).
The researchers defined quiescent disease as corticosteroid-free clinical remission with a Crohn’s Disease Activity Index (CDAI) of <50 for the past 3 months on a stable regimen.
Patients ingested a VCE at baseline and those with a Lewis inflammatory score (LS) of ≥350 were designated high risk (n = 40) and randomized to either T2T optimization (n = 20) or continuing standard care (n = 20).
T2T was optimized with repeat VCE results every 6 months. Patients with LS <350 (“low risk”) continued standard care. The primary outcome was the rate of disease exacerbation, demonstrated by a CDAI increase of >70 points and a score >150, or hospitalization/surgery, in high-risk standard care vs T2T groups at 24 months.
Treatment intensification in the high-risk group allocated to a proactive strategy comprised biologic dose escalation (n = 11 of 20), starting a biologic (n = 8 of 20), or swapping biologics (n = 1 of 20).
The primary outcome, clinical flare by 24 months, occurred in 5 of 20 (25%) of high-risk treat-to-target patients vs 14 of 20 (70%) of the high-risk standard-care group (odds ratio [OR], .14; 95% confidence interval [CI], .04–.57, P = .006).
Mucosal healing was significantly more common in the T2T group when determined by a cutoff LS < 350 (OR, 4.5, 95% CI, 1.7–17.4, nominal P value = .03), but not by the combined scores of total LS < 450 and highest-segment LS < 350.
Among all patients continuing standard care (n = 40), baseline LS was numerically higher among relapsers vs nonrelapsers (450, 225–900 vs 225, 135–600, respectively, P = .07).
As to safety, of 221 VCEs ingested, there was a single (.4%) temporary retention, which spontaneously resolved.
“VCE monitoring of CD was approved into government reimbursement in Israel last year, and I know several European countries are also considering the inclusion of this new indication for VCE in their payer reimbursement,” Ben-Horin told GI & Hepatology News. “Uptake in Israel is still baby-stepping. In our center it’s much more common to monitor T2T for small bowel patients, but this approach is still not widely applied.”
The authors cautioned that since the focus was the small bowel, the findings are not necessarily generalizable to patients with Crohn’s colitis.
The study was supported by the Leona M. & Harry B. Helmsley Charitable Trust, Medtronic (USA), AbbVie (Israel), and Takeda. The funders did not intervene in the design or interpretation of the study.
Ben-Horin reported advisory, consulting fees, research support, and/or stocks/options from several pharmaceutical firms. Several coauthors disclosed similar relations with private-sector companies.
A treat-to target (T2T) strategy based on video capsule endoscopy (VCE) identified Crohn’s disease (CD) patients in clinical remission but with small bowel inflammation, resulting in fewer clinical flares versus a treat-by-symptoms standard approach.
“A VCE-guided treat-to-target strategy for patients with CD in remission confers superior clinical outcomes compared with continued standard care,” investigators led by Shomron Ben-Horin, MD, director of gastroenterology at Sheba Medical Center in Ramat-Gan, Israel.
Published in Gastroenterology, the CURE-CD (Comprehensive Individualized Proactive Therapy of Crohn’s Disease), a prospective, temporally blinded, randomized controled trial, looked at 60 adult patients with quiescent CD involving the small bowel (either L1 or L3 iof the terminal ileum and upper colon).
The researchers defined quiescent disease as corticosteroid-free clinical remission with a Crohn’s Disease Activity Index (CDAI) of <50 for the past 3 months on a stable regimen.
Patients ingested a VCE at baseline and those with a Lewis inflammatory score (LS) of ≥350 were designated high risk (n = 40) and randomized to either T2T optimization (n = 20) or continuing standard care (n = 20).
T2T was optimized with repeat VCE results every 6 months. Patients with LS <350 (“low risk”) continued standard care. The primary outcome was the rate of disease exacerbation, demonstrated by a CDAI increase of >70 points and a score >150, or hospitalization/surgery, in high-risk standard care vs T2T groups at 24 months.
Treatment intensification in the high-risk group allocated to a proactive strategy comprised biologic dose escalation (n = 11 of 20), starting a biologic (n = 8 of 20), or swapping biologics (n = 1 of 20).
The primary outcome, clinical flare by 24 months, occurred in 5 of 20 (25%) of high-risk treat-to-target patients vs 14 of 20 (70%) of the high-risk standard-care group (odds ratio [OR], .14; 95% confidence interval [CI], .04–.57, P = .006).
Mucosal healing was significantly more common in the T2T group when determined by a cutoff LS < 350 (OR, 4.5, 95% CI, 1.7–17.4, nominal P value = .03), but not by the combined scores of total LS < 450 and highest-segment LS < 350.
Among all patients continuing standard care (n = 40), baseline LS was numerically higher among relapsers vs nonrelapsers (450, 225–900 vs 225, 135–600, respectively, P = .07).
As to safety, of 221 VCEs ingested, there was a single (.4%) temporary retention, which spontaneously resolved.
“VCE monitoring of CD was approved into government reimbursement in Israel last year, and I know several European countries are also considering the inclusion of this new indication for VCE in their payer reimbursement,” Ben-Horin told GI & Hepatology News. “Uptake in Israel is still baby-stepping. In our center it’s much more common to monitor T2T for small bowel patients, but this approach is still not widely applied.”
The authors cautioned that since the focus was the small bowel, the findings are not necessarily generalizable to patients with Crohn’s colitis.
The study was supported by the Leona M. & Harry B. Helmsley Charitable Trust, Medtronic (USA), AbbVie (Israel), and Takeda. The funders did not intervene in the design or interpretation of the study.
Ben-Horin reported advisory, consulting fees, research support, and/or stocks/options from several pharmaceutical firms. Several coauthors disclosed similar relations with private-sector companies.
FROM GASTROENTEROLOGY
MASH Driving Global Epidemic of Primary Liver Cancer
Although the incidence of PLC from most etiologies is declining, MASH and alcohol-related liver disease (ALD) are exceptions.
A recent analysis in Clinical Gastroenterology and Hepatology found a near doubling of cases in from 2000 to 2021 in data from the 2024 Global Burden of Disease study.
The analysis assessed age-standardized incidence, mortality, and disability-adjusted life years (DALYs) from MASH-associated PLC, stratified by geographical region, sociodemographic index, age, and sex.
The burden of MASH-associated primary liver cancer (PLC) is rising rapidly while, thanks to effective suppressive treatments, the incidence of PLC from viral hepatitis is declining.
“Given the shifting epidemiology and limited global data, this analysis was timely to provide updated, comprehensive estimates using the GBD 2021 database,” lead authors Ju Dong Yang, MD, MS, and Karn Wijarnpreecha, MD, MPH, told GI & Hepatology News in a joint email. Yang is an associate professor and medical director of the Liver Cancer Program at Cedars-Sinai Medical Center in Los Angeles, and Wijarnpreecha is a transplant hepatologist in the of Division of Gastroenterology at University of Arizona College of Medicine in Phoenix. “Our study helps identify regions, populations, and sex-specific trends that are most affected and informs global policy response.”
Interestingly,the United States ranks among the top three countries worldwide in terms of MASH-associated PLC burden, with nearly 3,400 newly diagnosed cases reported in 2021 alone. The Americas in general experienced the highest percentage increase in age-standardized incidence rate (APC, 2.09%, 95% CI, 2.02–2.16), age-standardized death rate (APC, 1.96%; 95% CI, 1.69–2.23), and age-standardized DALYs (APC, 1.96%; 95% CI, 1.63–2.30) from MASH-associated PLC.
Globally, there were 42,290 incident cases, 40,920 deaths, and 995,470 DALYs from PLC. Global incidence (+98%), death (+93%), and DALYs (+76%) from MASH-associated PLC increased steeply over the study period.
Among different etiologies, the global study found that only MASH-associated PLC had increased mortality rates, for an annual percent change of +0.46 (95% confidence interval [CI], .33%–.59%). Africa and low-sociodemographic index countries exhibited the highest age-standardized incidence, death, and DALYs from MASH-associated PLC.
MASH promotes PLC through chronic liver inflammation, oxidative stress, lipotoxicity, and fibrosis, which together create a procarcinogenic environment even in the absence of cirrhosis. “This distinct pathway makes MASH-associated PLC harder to detect early, especially when cirrhosis is not yet evident,” Yang and Wijarnpreecha said.
By gender, DALYs increased in females (APC, .24%, 95% CI, .06–.42) but remained stable in males. “Males have higher absolute rates of MASH-associated PLC in terms of incidence and DALYs. However, our study found that the rate of increase in MASH-associated PLC-related disability is steeper in females. This suggests a growing burden among women, possibly related to aging, hormonal changes, and cumulative metabolic risk,” the authors said. In terms of age, “while our study did not assess age at onset, separate analyses have shown that both MASH-associated and alcohol-associated liver cancer are rising among younger individuals.”
Yang and Wijarnpreecha emphasized the need for a multi-pronged remedial strategy, including broad public health policies targeting obesity and metabolic syndrome and better risk stratification tools such as no-invasive biomarkers and genetic profiling. They called for investment in liver cancer surveillance, especially in populations at risk, and special attention to sex disparities and health equity across regions.
“We’re entering a new era of liver cancer epidemiology, where MASLD is taking center stage. Clinicians must recognize that MASH can progress to liver cancer even without cirrhosis,” they said. “Early diagnosis and metabolic intervention may be the best tools to curb this trend, and sex-based approaches to risk stratification and treatment may be essential moving forward.”
Yang’s research is supported by the National Institutes of Health. He consults for AstraZeneca, Eisai, Exact Sciences, and FujiFilm Medical Sciences.
Reviewing this study for GI & Hepatology News, but not involved in it, Scott L. Friedman, MD, AGAF, chief emeritus of the Division of Liver Diseases at Mount Sinai Health System in New York City and director of the newly established multidisciplinary Mount Sinai Institute for Liver Research, said the increase in primary liver cancer burden revealed by the research has been recognized for several years, especially among liver specialists, and is worsening, particularly in America.
“This is most evident in the changing composition of liver transplant waiting lists, which include a diminishing number of patients with chronic viral hepatitis, and a growing fraction of patients with steatotic liver disease, either from MASH alone or with concurrent alcohol-associated liver disease,” Friedman said. He noted that apart from the brain, the liver is the body’s least understood organ.
Friedman said that an urgent need exists for increased awareness of and screening for steatotic liver disease in primary care and general medicine practices – especially in patients with type 2 diabetes, about 70% of whom typically have steatosis – as well as those with features of the metabolic syndrome, with obesity, type 2 diabetes, lipid abnormalities and hypertension. “Awareness of metabolic-associated liver disease and MASH among patients and providers is still inadequate,” he said. “However, now that there’s a newly approved drug, Rezdiffra [resmetirom] – and more likely in the coming years – early detection and treatment of MASH will become essential to prevent its progression to cirrhosis and PLC through specific medications.”
Once patients with MASH have more advanced fibrosis, Friedman noted, regular screening for PLC is essential to detect early cancers that are still curable either by liver resection, liver transplant, or direct ablation of small tumors. “Unfortunately, it is not unusual for patients to present with an incurable PLC without realizing they had any underlying liver disease, since MASH is not associated with specific liver symptoms.”
Friedman disclosed no competing interests relevant to his comments.
Reviewing this study for GI & Hepatology News, but not involved in it, Scott L. Friedman, MD, AGAF, chief emeritus of the Division of Liver Diseases at Mount Sinai Health System in New York City and director of the newly established multidisciplinary Mount Sinai Institute for Liver Research, said the increase in primary liver cancer burden revealed by the research has been recognized for several years, especially among liver specialists, and is worsening, particularly in America.
“This is most evident in the changing composition of liver transplant waiting lists, which include a diminishing number of patients with chronic viral hepatitis, and a growing fraction of patients with steatotic liver disease, either from MASH alone or with concurrent alcohol-associated liver disease,” Friedman said. He noted that apart from the brain, the liver is the body’s least understood organ.
Friedman said that an urgent need exists for increased awareness of and screening for steatotic liver disease in primary care and general medicine practices – especially in patients with type 2 diabetes, about 70% of whom typically have steatosis – as well as those with features of the metabolic syndrome, with obesity, type 2 diabetes, lipid abnormalities and hypertension. “Awareness of metabolic-associated liver disease and MASH among patients and providers is still inadequate,” he said. “However, now that there’s a newly approved drug, Rezdiffra [resmetirom] – and more likely in the coming years – early detection and treatment of MASH will become essential to prevent its progression to cirrhosis and PLC through specific medications.”
Once patients with MASH have more advanced fibrosis, Friedman noted, regular screening for PLC is essential to detect early cancers that are still curable either by liver resection, liver transplant, or direct ablation of small tumors. “Unfortunately, it is not unusual for patients to present with an incurable PLC without realizing they had any underlying liver disease, since MASH is not associated with specific liver symptoms.”
Friedman disclosed no competing interests relevant to his comments.
Reviewing this study for GI & Hepatology News, but not involved in it, Scott L. Friedman, MD, AGAF, chief emeritus of the Division of Liver Diseases at Mount Sinai Health System in New York City and director of the newly established multidisciplinary Mount Sinai Institute for Liver Research, said the increase in primary liver cancer burden revealed by the research has been recognized for several years, especially among liver specialists, and is worsening, particularly in America.
“This is most evident in the changing composition of liver transplant waiting lists, which include a diminishing number of patients with chronic viral hepatitis, and a growing fraction of patients with steatotic liver disease, either from MASH alone or with concurrent alcohol-associated liver disease,” Friedman said. He noted that apart from the brain, the liver is the body’s least understood organ.
Friedman said that an urgent need exists for increased awareness of and screening for steatotic liver disease in primary care and general medicine practices – especially in patients with type 2 diabetes, about 70% of whom typically have steatosis – as well as those with features of the metabolic syndrome, with obesity, type 2 diabetes, lipid abnormalities and hypertension. “Awareness of metabolic-associated liver disease and MASH among patients and providers is still inadequate,” he said. “However, now that there’s a newly approved drug, Rezdiffra [resmetirom] – and more likely in the coming years – early detection and treatment of MASH will become essential to prevent its progression to cirrhosis and PLC through specific medications.”
Once patients with MASH have more advanced fibrosis, Friedman noted, regular screening for PLC is essential to detect early cancers that are still curable either by liver resection, liver transplant, or direct ablation of small tumors. “Unfortunately, it is not unusual for patients to present with an incurable PLC without realizing they had any underlying liver disease, since MASH is not associated with specific liver symptoms.”
Friedman disclosed no competing interests relevant to his comments.
Although the incidence of PLC from most etiologies is declining, MASH and alcohol-related liver disease (ALD) are exceptions.
A recent analysis in Clinical Gastroenterology and Hepatology found a near doubling of cases in from 2000 to 2021 in data from the 2024 Global Burden of Disease study.
The analysis assessed age-standardized incidence, mortality, and disability-adjusted life years (DALYs) from MASH-associated PLC, stratified by geographical region, sociodemographic index, age, and sex.
The burden of MASH-associated primary liver cancer (PLC) is rising rapidly while, thanks to effective suppressive treatments, the incidence of PLC from viral hepatitis is declining.
“Given the shifting epidemiology and limited global data, this analysis was timely to provide updated, comprehensive estimates using the GBD 2021 database,” lead authors Ju Dong Yang, MD, MS, and Karn Wijarnpreecha, MD, MPH, told GI & Hepatology News in a joint email. Yang is an associate professor and medical director of the Liver Cancer Program at Cedars-Sinai Medical Center in Los Angeles, and Wijarnpreecha is a transplant hepatologist in the of Division of Gastroenterology at University of Arizona College of Medicine in Phoenix. “Our study helps identify regions, populations, and sex-specific trends that are most affected and informs global policy response.”
Interestingly,the United States ranks among the top three countries worldwide in terms of MASH-associated PLC burden, with nearly 3,400 newly diagnosed cases reported in 2021 alone. The Americas in general experienced the highest percentage increase in age-standardized incidence rate (APC, 2.09%, 95% CI, 2.02–2.16), age-standardized death rate (APC, 1.96%; 95% CI, 1.69–2.23), and age-standardized DALYs (APC, 1.96%; 95% CI, 1.63–2.30) from MASH-associated PLC.
Globally, there were 42,290 incident cases, 40,920 deaths, and 995,470 DALYs from PLC. Global incidence (+98%), death (+93%), and DALYs (+76%) from MASH-associated PLC increased steeply over the study period.
Among different etiologies, the global study found that only MASH-associated PLC had increased mortality rates, for an annual percent change of +0.46 (95% confidence interval [CI], .33%–.59%). Africa and low-sociodemographic index countries exhibited the highest age-standardized incidence, death, and DALYs from MASH-associated PLC.
MASH promotes PLC through chronic liver inflammation, oxidative stress, lipotoxicity, and fibrosis, which together create a procarcinogenic environment even in the absence of cirrhosis. “This distinct pathway makes MASH-associated PLC harder to detect early, especially when cirrhosis is not yet evident,” Yang and Wijarnpreecha said.
By gender, DALYs increased in females (APC, .24%, 95% CI, .06–.42) but remained stable in males. “Males have higher absolute rates of MASH-associated PLC in terms of incidence and DALYs. However, our study found that the rate of increase in MASH-associated PLC-related disability is steeper in females. This suggests a growing burden among women, possibly related to aging, hormonal changes, and cumulative metabolic risk,” the authors said. In terms of age, “while our study did not assess age at onset, separate analyses have shown that both MASH-associated and alcohol-associated liver cancer are rising among younger individuals.”
Yang and Wijarnpreecha emphasized the need for a multi-pronged remedial strategy, including broad public health policies targeting obesity and metabolic syndrome and better risk stratification tools such as no-invasive biomarkers and genetic profiling. They called for investment in liver cancer surveillance, especially in populations at risk, and special attention to sex disparities and health equity across regions.
“We’re entering a new era of liver cancer epidemiology, where MASLD is taking center stage. Clinicians must recognize that MASH can progress to liver cancer even without cirrhosis,” they said. “Early diagnosis and metabolic intervention may be the best tools to curb this trend, and sex-based approaches to risk stratification and treatment may be essential moving forward.”
Yang’s research is supported by the National Institutes of Health. He consults for AstraZeneca, Eisai, Exact Sciences, and FujiFilm Medical Sciences.
Although the incidence of PLC from most etiologies is declining, MASH and alcohol-related liver disease (ALD) are exceptions.
A recent analysis in Clinical Gastroenterology and Hepatology found a near doubling of cases in from 2000 to 2021 in data from the 2024 Global Burden of Disease study.
The analysis assessed age-standardized incidence, mortality, and disability-adjusted life years (DALYs) from MASH-associated PLC, stratified by geographical region, sociodemographic index, age, and sex.
The burden of MASH-associated primary liver cancer (PLC) is rising rapidly while, thanks to effective suppressive treatments, the incidence of PLC from viral hepatitis is declining.
“Given the shifting epidemiology and limited global data, this analysis was timely to provide updated, comprehensive estimates using the GBD 2021 database,” lead authors Ju Dong Yang, MD, MS, and Karn Wijarnpreecha, MD, MPH, told GI & Hepatology News in a joint email. Yang is an associate professor and medical director of the Liver Cancer Program at Cedars-Sinai Medical Center in Los Angeles, and Wijarnpreecha is a transplant hepatologist in the of Division of Gastroenterology at University of Arizona College of Medicine in Phoenix. “Our study helps identify regions, populations, and sex-specific trends that are most affected and informs global policy response.”
Interestingly,the United States ranks among the top three countries worldwide in terms of MASH-associated PLC burden, with nearly 3,400 newly diagnosed cases reported in 2021 alone. The Americas in general experienced the highest percentage increase in age-standardized incidence rate (APC, 2.09%, 95% CI, 2.02–2.16), age-standardized death rate (APC, 1.96%; 95% CI, 1.69–2.23), and age-standardized DALYs (APC, 1.96%; 95% CI, 1.63–2.30) from MASH-associated PLC.
Globally, there were 42,290 incident cases, 40,920 deaths, and 995,470 DALYs from PLC. Global incidence (+98%), death (+93%), and DALYs (+76%) from MASH-associated PLC increased steeply over the study period.
Among different etiologies, the global study found that only MASH-associated PLC had increased mortality rates, for an annual percent change of +0.46 (95% confidence interval [CI], .33%–.59%). Africa and low-sociodemographic index countries exhibited the highest age-standardized incidence, death, and DALYs from MASH-associated PLC.
MASH promotes PLC through chronic liver inflammation, oxidative stress, lipotoxicity, and fibrosis, which together create a procarcinogenic environment even in the absence of cirrhosis. “This distinct pathway makes MASH-associated PLC harder to detect early, especially when cirrhosis is not yet evident,” Yang and Wijarnpreecha said.
By gender, DALYs increased in females (APC, .24%, 95% CI, .06–.42) but remained stable in males. “Males have higher absolute rates of MASH-associated PLC in terms of incidence and DALYs. However, our study found that the rate of increase in MASH-associated PLC-related disability is steeper in females. This suggests a growing burden among women, possibly related to aging, hormonal changes, and cumulative metabolic risk,” the authors said. In terms of age, “while our study did not assess age at onset, separate analyses have shown that both MASH-associated and alcohol-associated liver cancer are rising among younger individuals.”
Yang and Wijarnpreecha emphasized the need for a multi-pronged remedial strategy, including broad public health policies targeting obesity and metabolic syndrome and better risk stratification tools such as no-invasive biomarkers and genetic profiling. They called for investment in liver cancer surveillance, especially in populations at risk, and special attention to sex disparities and health equity across regions.
“We’re entering a new era of liver cancer epidemiology, where MASLD is taking center stage. Clinicians must recognize that MASH can progress to liver cancer even without cirrhosis,” they said. “Early diagnosis and metabolic intervention may be the best tools to curb this trend, and sex-based approaches to risk stratification and treatment may be essential moving forward.”
Yang’s research is supported by the National Institutes of Health. He consults for AstraZeneca, Eisai, Exact Sciences, and FujiFilm Medical Sciences.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Colonoscopy Screening Effective in 45- to 49-Year-Olds
Researchers at Kaiser Permanente Northern California sought to compare yields between the two age groups to assess how a change in guidance in 2021 urging screening in the younger cohort was borne out in a real-world setting.
The researchers published their findings in JAMA, concluding that the results supported screening colonoscopy in 45- to 49-year-olds.
The study compared 4380 individuals aged 45-49 years, with 7651 who were aged 50-54. All of them underwent their first colonoscopy during 2021 to 2024. Thirty-five percent of the younger group and 40% of the older group had any adenoma.
About 4% of each group had an advanced adenoma, 10% had any sessile serrated lesion, a little under 2% had an advanced serrated lesion, and 0.1% in each group had colorectal cancer.
There were no significant differences in neoplasia prevalence between the groups by sex. The authors did note that the study group included more Asian individuals (30%) than in the general population.
Swati G. Patel, MD, MS, director of the Gastrointestinal Hereditary Cancer Program at the University of Colorado Anschutz Medical Center, Denver, said the Kaiser study is important because its data was aggregated after the US Preventive Services Task Force lowered the screening age in 2021.
The Kaiser research “validates the initial studies” done to support that recommendation and the 2022 consensus statement by the US Multi-Society Task Force on Colorectal Cancer, which also advocated screening in 45- to 49-year-olds.
Even though the new JAMA study found a similar rate of cancers and precursor lesions as in previous trials, it provides “reinforcement of the rationale for decreasing the screening age,” Patel, the lead author on the consensus statement, told GI & Hepatology News.
The Kaiser research is “really powerful information,” she said.
“It certainly validates our current guidance to start screening for colorectal cancer at age 45,” said Audrey Calderwood, MD, director of the GI Cancer Risk and Prevention Clinic at the Geisel School of Medicine, Dartmouth, New Hampshire.
The Kaiser data provides granular information to share with younger patients who might think that they don’t need screening because they are healthy and don’t have symptoms, said Calderwood, also director of the Comprehensive Gastroenterology Center at Dartmouth Hitchcock Medical Center.
Colon cancer rates for Americans under age 50 have been steadily rising for the past decade, hitting about 10 cases per 100,000 in 2022, according to the National Cancer Institute (NCI). In 2023, about 73% of eligible 50- to 75-year-olds received colorectal cancer screening based on the most recent guidelines, according to the NCI.
But screening rates in the under-50 age group are much lower. Researchers estimated in a study that only about 34.5% of those aged 45-49 received colorectal cancer screening, which included colonoscopy, stool-based tests, and CT colonography.
Patel said that estimate is “spot on” in terms of other estimates.
“I think there’s a perception that it’s a cancer of older adults and that young healthy people don’t need to worry about it,” she said, adding that getting the word out to younger Americans is a “PR challenge,” in part because of squeamishness about discussing anything to do with stool and changes in how they access information.
Calderwood agreed. Younger people “aren’t chatting to their friends about” colon cancer screening the way they might about mammography, said Calderwood.
Both she and Patel noted that educating the public was an ongoing project, but that a physician’s recommendation was key.
Patel said she hoped that data provided in the Kaiser study might help “dismantle the systemic skepticism around decreasing the age recommendation” for screening.
Calderwood and Patel reported having no relevant financial relationships.
A version of this article appeared on Medscape.com.
Researchers at Kaiser Permanente Northern California sought to compare yields between the two age groups to assess how a change in guidance in 2021 urging screening in the younger cohort was borne out in a real-world setting.
The researchers published their findings in JAMA, concluding that the results supported screening colonoscopy in 45- to 49-year-olds.
The study compared 4380 individuals aged 45-49 years, with 7651 who were aged 50-54. All of them underwent their first colonoscopy during 2021 to 2024. Thirty-five percent of the younger group and 40% of the older group had any adenoma.
About 4% of each group had an advanced adenoma, 10% had any sessile serrated lesion, a little under 2% had an advanced serrated lesion, and 0.1% in each group had colorectal cancer.
There were no significant differences in neoplasia prevalence between the groups by sex. The authors did note that the study group included more Asian individuals (30%) than in the general population.
Swati G. Patel, MD, MS, director of the Gastrointestinal Hereditary Cancer Program at the University of Colorado Anschutz Medical Center, Denver, said the Kaiser study is important because its data was aggregated after the US Preventive Services Task Force lowered the screening age in 2021.
The Kaiser research “validates the initial studies” done to support that recommendation and the 2022 consensus statement by the US Multi-Society Task Force on Colorectal Cancer, which also advocated screening in 45- to 49-year-olds.
Even though the new JAMA study found a similar rate of cancers and precursor lesions as in previous trials, it provides “reinforcement of the rationale for decreasing the screening age,” Patel, the lead author on the consensus statement, told GI & Hepatology News.
The Kaiser research is “really powerful information,” she said.
“It certainly validates our current guidance to start screening for colorectal cancer at age 45,” said Audrey Calderwood, MD, director of the GI Cancer Risk and Prevention Clinic at the Geisel School of Medicine, Dartmouth, New Hampshire.
The Kaiser data provides granular information to share with younger patients who might think that they don’t need screening because they are healthy and don’t have symptoms, said Calderwood, also director of the Comprehensive Gastroenterology Center at Dartmouth Hitchcock Medical Center.
Colon cancer rates for Americans under age 50 have been steadily rising for the past decade, hitting about 10 cases per 100,000 in 2022, according to the National Cancer Institute (NCI). In 2023, about 73% of eligible 50- to 75-year-olds received colorectal cancer screening based on the most recent guidelines, according to the NCI.
But screening rates in the under-50 age group are much lower. Researchers estimated in a study that only about 34.5% of those aged 45-49 received colorectal cancer screening, which included colonoscopy, stool-based tests, and CT colonography.
Patel said that estimate is “spot on” in terms of other estimates.
“I think there’s a perception that it’s a cancer of older adults and that young healthy people don’t need to worry about it,” she said, adding that getting the word out to younger Americans is a “PR challenge,” in part because of squeamishness about discussing anything to do with stool and changes in how they access information.
Calderwood agreed. Younger people “aren’t chatting to their friends about” colon cancer screening the way they might about mammography, said Calderwood.
Both she and Patel noted that educating the public was an ongoing project, but that a physician’s recommendation was key.
Patel said she hoped that data provided in the Kaiser study might help “dismantle the systemic skepticism around decreasing the age recommendation” for screening.
Calderwood and Patel reported having no relevant financial relationships.
A version of this article appeared on Medscape.com.
Researchers at Kaiser Permanente Northern California sought to compare yields between the two age groups to assess how a change in guidance in 2021 urging screening in the younger cohort was borne out in a real-world setting.
The researchers published their findings in JAMA, concluding that the results supported screening colonoscopy in 45- to 49-year-olds.
The study compared 4380 individuals aged 45-49 years, with 7651 who were aged 50-54. All of them underwent their first colonoscopy during 2021 to 2024. Thirty-five percent of the younger group and 40% of the older group had any adenoma.
About 4% of each group had an advanced adenoma, 10% had any sessile serrated lesion, a little under 2% had an advanced serrated lesion, and 0.1% in each group had colorectal cancer.
There were no significant differences in neoplasia prevalence between the groups by sex. The authors did note that the study group included more Asian individuals (30%) than in the general population.
Swati G. Patel, MD, MS, director of the Gastrointestinal Hereditary Cancer Program at the University of Colorado Anschutz Medical Center, Denver, said the Kaiser study is important because its data was aggregated after the US Preventive Services Task Force lowered the screening age in 2021.
The Kaiser research “validates the initial studies” done to support that recommendation and the 2022 consensus statement by the US Multi-Society Task Force on Colorectal Cancer, which also advocated screening in 45- to 49-year-olds.
Even though the new JAMA study found a similar rate of cancers and precursor lesions as in previous trials, it provides “reinforcement of the rationale for decreasing the screening age,” Patel, the lead author on the consensus statement, told GI & Hepatology News.
The Kaiser research is “really powerful information,” she said.
“It certainly validates our current guidance to start screening for colorectal cancer at age 45,” said Audrey Calderwood, MD, director of the GI Cancer Risk and Prevention Clinic at the Geisel School of Medicine, Dartmouth, New Hampshire.
The Kaiser data provides granular information to share with younger patients who might think that they don’t need screening because they are healthy and don’t have symptoms, said Calderwood, also director of the Comprehensive Gastroenterology Center at Dartmouth Hitchcock Medical Center.
Colon cancer rates for Americans under age 50 have been steadily rising for the past decade, hitting about 10 cases per 100,000 in 2022, according to the National Cancer Institute (NCI). In 2023, about 73% of eligible 50- to 75-year-olds received colorectal cancer screening based on the most recent guidelines, according to the NCI.
But screening rates in the under-50 age group are much lower. Researchers estimated in a study that only about 34.5% of those aged 45-49 received colorectal cancer screening, which included colonoscopy, stool-based tests, and CT colonography.
Patel said that estimate is “spot on” in terms of other estimates.
“I think there’s a perception that it’s a cancer of older adults and that young healthy people don’t need to worry about it,” she said, adding that getting the word out to younger Americans is a “PR challenge,” in part because of squeamishness about discussing anything to do with stool and changes in how they access information.
Calderwood agreed. Younger people “aren’t chatting to their friends about” colon cancer screening the way they might about mammography, said Calderwood.
Both she and Patel noted that educating the public was an ongoing project, but that a physician’s recommendation was key.
Patel said she hoped that data provided in the Kaiser study might help “dismantle the systemic skepticism around decreasing the age recommendation” for screening.
Calderwood and Patel reported having no relevant financial relationships.
A version of this article appeared on Medscape.com.
Less Invasive Screening May Identify Barrett’s Esophagus Earlier
, a small comparative study in US veterans found.
BE is up to three times more prevalent in veterans than in the general population.
This and other minimally invasive approaches may reduce patient anxiety and increase screening rates, according to investigators led by Katarina B. Greer, MD, MS, of the VA Northeast Ohio Healthcare System and Case Western University in Cleveland. Such screening platforms are expected to open a window on improved prognosis for EAC by offering well-tolerated, office-based testing, the authors wrote in The American Journal of Gastroenterology.
Greer and colleagues compared standard upper endoscopy with EsoCheck (EC), a nonendoscopic esophageal balloon cell-sampling device coupled with EsoGuard (EG), a DNA-based precancer screening assay, with standard upper endoscopy, an FDA-approved minimally invasive alternative.
Sensitivity and specificity of combined EC/EG for esophagogastroduodenoscopy (EGD)-detected BE/EAC were 92.9% (95% CI, 66.1-99.8) and 72.2% (95% CI, 62.1-80.8), respectively. Positive and negative predictive values were 32.5% (95% CI, 18.6-49.1) and 98.6% (95% CI, 92.4-100), respectively.
“With its strong negative predictive power, this screening modality could be a first-line tool available to a greater number of patients,” Greer and associates wrote. “Data from this test support the notion that EC could be performed as a triaging test to increase the yield of diagnostic upper endoscopy 2.5-fold.”
The US rates of EAC have increased more than six-fold in the past four decades and continue to rise. In 2023, 21,560 cases of EAC were diagnosed here. The prognosis for EAC is still poor, with fewer than 22% of patients surviving beyond 5 years.
Current guidelines recommend sedated EGD for patients with chronic gastroesophageal reflux disease (GERD) and additional BE risk factors such as smoking, obesity, and family history. This strategy, however, often fails to detect BE when symptoms are well controlled with over-the-counter or physician-prescribed therapies, Greer and colleagues noted. It also fails to detect BE in individuals without GERD, who comprise 40% of those who develop EAC.
Fewer than 5% of EACs are diagnosed as early-stage lesions caught by surveillance of patients with previously detected BE.
Study Details
The researchers recruited veterans meeting American College of Gastroenterology criteria for endoscopic BE and EAC screening at the Louis Stokes Cleveland Veterans Affairs Medical Center.
Of 782 eligible veterans, 130 (16.6%) entered the study and 124 completed screening. Common reasons for nonparticipation included completion of upper endoscopy outside of the VA healthcare system, lack of interest in joining a research study, and no recommendation for screening from referring gastroenterology or primary care providers. Eligible candidates had gastroesophageal reflux disorder plus three additional risk factors, such as smoking, higher BMI, male sex, age 50 years or older, and family history. The mean number of risk factors was 4.1.
“Available data suggest that family history is the strongest predictor of BE diagnosis, as prevalence of BE among those with family history was 23%,” Greer’s group wrote. “This points to high priority of pursuing screening in patients with family history of the condition, followed by patients who share multiple risk factors.”
All participants completed unsedated EC-guided distal esophageal sampling followed by a sedated EGD on the same day. The prevalence of BE/EAC was 12.9% (n = 14/2), based on standard EGD.
“The study was not powered to prospectively determine EC diagnostic accuracy for subgroups of nondysplastic and dysplastic BE and EAC. These data are reported for this device in development studies but not available for our study population,” the authors wrote. In comparison, they noted, the Cytosponge-TFF3, another nonendoscopic screening device for EAC and BE, exhibited lower sensitivity of 79.5%-87.2%, depending on lesion length, but higher specificity of 92.4%.
Procedural Anxiety
Baseline scores on the short-form six-item Spielberger State-Trait Anxiety Inventory-6 (STAI-6) revealed notable levels of periprocedural anxiety. STAI-6 scores range from 20 to 80, with higher scores indicating more severe anxiety. In the VA study, scores ranged from 20 to 60, and most domains constituting the scores were the same before and after the procedure. Participants did, however, report a statistically significant decrease in sense of worry after EC and reported good tolerability for both EC and EG.
Offering an outsider’s perspective on the study, Joshua Sloan, DO, an esophageal gastroenterologist at University of Minnesota Medical Center in Minneapolis, said that with the acceleration of US rates of EAC, developing a nonendoscopic screening tool to improve identification of Barrett’s and perhaps early EAC is important. “The study by Greer et al helps support the use of nonendoscopic screening with EsoCheck and EsoGuard to identify these conditions,” he told GI & Hepatology News. “It will be interesting to see similar studies in the non-VA population as well. As the study notes, veterans are an enriched population with a higher prevalence of Barrett’s esophagus.”
Ultimately, Sloan added, “the hope is to increase our ability to identify and manage BE before it becomes EAC. Nonendoscopic screening tools have the potential to increase diagnosis and funnel the appropriate patients for endoscopic surveillance.”
The Bottom Line
“Calculations regarding effectiveness of the two-step screening strategy afforded by EC indicate that the burden of screening would be reduced by at least half (53%),” the authors wrote. Since the estimated size of the US screen-eligible population ranges from 19.7 million to 120.1 million, noninvasive tools could significantly decrease EGD procedures. A formal cost effectiveness analysis is being conducted and will be published separately.
This study was funded by a Department of Defense award.
Co-Author Chak reported device patents assigned to Case Western Reserve University and licensed to Lucid Diagnostics. The other authors had no competing interests to declare. Sloan disclosed speaking and/or advisory work for Sanofi-Regeneron, Phathom Pharmaceuticals, and Takeda Pharmaceuticals unrelated to his comments.
A version of this article appeared on Medscape.com.
, a small comparative study in US veterans found.
BE is up to three times more prevalent in veterans than in the general population.
This and other minimally invasive approaches may reduce patient anxiety and increase screening rates, according to investigators led by Katarina B. Greer, MD, MS, of the VA Northeast Ohio Healthcare System and Case Western University in Cleveland. Such screening platforms are expected to open a window on improved prognosis for EAC by offering well-tolerated, office-based testing, the authors wrote in The American Journal of Gastroenterology.
Greer and colleagues compared standard upper endoscopy with EsoCheck (EC), a nonendoscopic esophageal balloon cell-sampling device coupled with EsoGuard (EG), a DNA-based precancer screening assay, with standard upper endoscopy, an FDA-approved minimally invasive alternative.
Sensitivity and specificity of combined EC/EG for esophagogastroduodenoscopy (EGD)-detected BE/EAC were 92.9% (95% CI, 66.1-99.8) and 72.2% (95% CI, 62.1-80.8), respectively. Positive and negative predictive values were 32.5% (95% CI, 18.6-49.1) and 98.6% (95% CI, 92.4-100), respectively.
“With its strong negative predictive power, this screening modality could be a first-line tool available to a greater number of patients,” Greer and associates wrote. “Data from this test support the notion that EC could be performed as a triaging test to increase the yield of diagnostic upper endoscopy 2.5-fold.”
The US rates of EAC have increased more than six-fold in the past four decades and continue to rise. In 2023, 21,560 cases of EAC were diagnosed here. The prognosis for EAC is still poor, with fewer than 22% of patients surviving beyond 5 years.
Current guidelines recommend sedated EGD for patients with chronic gastroesophageal reflux disease (GERD) and additional BE risk factors such as smoking, obesity, and family history. This strategy, however, often fails to detect BE when symptoms are well controlled with over-the-counter or physician-prescribed therapies, Greer and colleagues noted. It also fails to detect BE in individuals without GERD, who comprise 40% of those who develop EAC.
Fewer than 5% of EACs are diagnosed as early-stage lesions caught by surveillance of patients with previously detected BE.
Study Details
The researchers recruited veterans meeting American College of Gastroenterology criteria for endoscopic BE and EAC screening at the Louis Stokes Cleveland Veterans Affairs Medical Center.
Of 782 eligible veterans, 130 (16.6%) entered the study and 124 completed screening. Common reasons for nonparticipation included completion of upper endoscopy outside of the VA healthcare system, lack of interest in joining a research study, and no recommendation for screening from referring gastroenterology or primary care providers. Eligible candidates had gastroesophageal reflux disorder plus three additional risk factors, such as smoking, higher BMI, male sex, age 50 years or older, and family history. The mean number of risk factors was 4.1.
“Available data suggest that family history is the strongest predictor of BE diagnosis, as prevalence of BE among those with family history was 23%,” Greer’s group wrote. “This points to high priority of pursuing screening in patients with family history of the condition, followed by patients who share multiple risk factors.”
All participants completed unsedated EC-guided distal esophageal sampling followed by a sedated EGD on the same day. The prevalence of BE/EAC was 12.9% (n = 14/2), based on standard EGD.
“The study was not powered to prospectively determine EC diagnostic accuracy for subgroups of nondysplastic and dysplastic BE and EAC. These data are reported for this device in development studies but not available for our study population,” the authors wrote. In comparison, they noted, the Cytosponge-TFF3, another nonendoscopic screening device for EAC and BE, exhibited lower sensitivity of 79.5%-87.2%, depending on lesion length, but higher specificity of 92.4%.
Procedural Anxiety
Baseline scores on the short-form six-item Spielberger State-Trait Anxiety Inventory-6 (STAI-6) revealed notable levels of periprocedural anxiety. STAI-6 scores range from 20 to 80, with higher scores indicating more severe anxiety. In the VA study, scores ranged from 20 to 60, and most domains constituting the scores were the same before and after the procedure. Participants did, however, report a statistically significant decrease in sense of worry after EC and reported good tolerability for both EC and EG.
Offering an outsider’s perspective on the study, Joshua Sloan, DO, an esophageal gastroenterologist at University of Minnesota Medical Center in Minneapolis, said that with the acceleration of US rates of EAC, developing a nonendoscopic screening tool to improve identification of Barrett’s and perhaps early EAC is important. “The study by Greer et al helps support the use of nonendoscopic screening with EsoCheck and EsoGuard to identify these conditions,” he told GI & Hepatology News. “It will be interesting to see similar studies in the non-VA population as well. As the study notes, veterans are an enriched population with a higher prevalence of Barrett’s esophagus.”
Ultimately, Sloan added, “the hope is to increase our ability to identify and manage BE before it becomes EAC. Nonendoscopic screening tools have the potential to increase diagnosis and funnel the appropriate patients for endoscopic surveillance.”
The Bottom Line
“Calculations regarding effectiveness of the two-step screening strategy afforded by EC indicate that the burden of screening would be reduced by at least half (53%),” the authors wrote. Since the estimated size of the US screen-eligible population ranges from 19.7 million to 120.1 million, noninvasive tools could significantly decrease EGD procedures. A formal cost effectiveness analysis is being conducted and will be published separately.
This study was funded by a Department of Defense award.
Co-Author Chak reported device patents assigned to Case Western Reserve University and licensed to Lucid Diagnostics. The other authors had no competing interests to declare. Sloan disclosed speaking and/or advisory work for Sanofi-Regeneron, Phathom Pharmaceuticals, and Takeda Pharmaceuticals unrelated to his comments.
A version of this article appeared on Medscape.com.
, a small comparative study in US veterans found.
BE is up to three times more prevalent in veterans than in the general population.
This and other minimally invasive approaches may reduce patient anxiety and increase screening rates, according to investigators led by Katarina B. Greer, MD, MS, of the VA Northeast Ohio Healthcare System and Case Western University in Cleveland. Such screening platforms are expected to open a window on improved prognosis for EAC by offering well-tolerated, office-based testing, the authors wrote in The American Journal of Gastroenterology.
Greer and colleagues compared standard upper endoscopy with EsoCheck (EC), a nonendoscopic esophageal balloon cell-sampling device coupled with EsoGuard (EG), a DNA-based precancer screening assay, with standard upper endoscopy, an FDA-approved minimally invasive alternative.
Sensitivity and specificity of combined EC/EG for esophagogastroduodenoscopy (EGD)-detected BE/EAC were 92.9% (95% CI, 66.1-99.8) and 72.2% (95% CI, 62.1-80.8), respectively. Positive and negative predictive values were 32.5% (95% CI, 18.6-49.1) and 98.6% (95% CI, 92.4-100), respectively.
“With its strong negative predictive power, this screening modality could be a first-line tool available to a greater number of patients,” Greer and associates wrote. “Data from this test support the notion that EC could be performed as a triaging test to increase the yield of diagnostic upper endoscopy 2.5-fold.”
The US rates of EAC have increased more than six-fold in the past four decades and continue to rise. In 2023, 21,560 cases of EAC were diagnosed here. The prognosis for EAC is still poor, with fewer than 22% of patients surviving beyond 5 years.
Current guidelines recommend sedated EGD for patients with chronic gastroesophageal reflux disease (GERD) and additional BE risk factors such as smoking, obesity, and family history. This strategy, however, often fails to detect BE when symptoms are well controlled with over-the-counter or physician-prescribed therapies, Greer and colleagues noted. It also fails to detect BE in individuals without GERD, who comprise 40% of those who develop EAC.
Fewer than 5% of EACs are diagnosed as early-stage lesions caught by surveillance of patients with previously detected BE.
Study Details
The researchers recruited veterans meeting American College of Gastroenterology criteria for endoscopic BE and EAC screening at the Louis Stokes Cleveland Veterans Affairs Medical Center.
Of 782 eligible veterans, 130 (16.6%) entered the study and 124 completed screening. Common reasons for nonparticipation included completion of upper endoscopy outside of the VA healthcare system, lack of interest in joining a research study, and no recommendation for screening from referring gastroenterology or primary care providers. Eligible candidates had gastroesophageal reflux disorder plus three additional risk factors, such as smoking, higher BMI, male sex, age 50 years or older, and family history. The mean number of risk factors was 4.1.
“Available data suggest that family history is the strongest predictor of BE diagnosis, as prevalence of BE among those with family history was 23%,” Greer’s group wrote. “This points to high priority of pursuing screening in patients with family history of the condition, followed by patients who share multiple risk factors.”
All participants completed unsedated EC-guided distal esophageal sampling followed by a sedated EGD on the same day. The prevalence of BE/EAC was 12.9% (n = 14/2), based on standard EGD.
“The study was not powered to prospectively determine EC diagnostic accuracy for subgroups of nondysplastic and dysplastic BE and EAC. These data are reported for this device in development studies but not available for our study population,” the authors wrote. In comparison, they noted, the Cytosponge-TFF3, another nonendoscopic screening device for EAC and BE, exhibited lower sensitivity of 79.5%-87.2%, depending on lesion length, but higher specificity of 92.4%.
Procedural Anxiety
Baseline scores on the short-form six-item Spielberger State-Trait Anxiety Inventory-6 (STAI-6) revealed notable levels of periprocedural anxiety. STAI-6 scores range from 20 to 80, with higher scores indicating more severe anxiety. In the VA study, scores ranged from 20 to 60, and most domains constituting the scores were the same before and after the procedure. Participants did, however, report a statistically significant decrease in sense of worry after EC and reported good tolerability for both EC and EG.
Offering an outsider’s perspective on the study, Joshua Sloan, DO, an esophageal gastroenterologist at University of Minnesota Medical Center in Minneapolis, said that with the acceleration of US rates of EAC, developing a nonendoscopic screening tool to improve identification of Barrett’s and perhaps early EAC is important. “The study by Greer et al helps support the use of nonendoscopic screening with EsoCheck and EsoGuard to identify these conditions,” he told GI & Hepatology News. “It will be interesting to see similar studies in the non-VA population as well. As the study notes, veterans are an enriched population with a higher prevalence of Barrett’s esophagus.”
Ultimately, Sloan added, “the hope is to increase our ability to identify and manage BE before it becomes EAC. Nonendoscopic screening tools have the potential to increase diagnosis and funnel the appropriate patients for endoscopic surveillance.”
The Bottom Line
“Calculations regarding effectiveness of the two-step screening strategy afforded by EC indicate that the burden of screening would be reduced by at least half (53%),” the authors wrote. Since the estimated size of the US screen-eligible population ranges from 19.7 million to 120.1 million, noninvasive tools could significantly decrease EGD procedures. A formal cost effectiveness analysis is being conducted and will be published separately.
This study was funded by a Department of Defense award.
Co-Author Chak reported device patents assigned to Case Western Reserve University and licensed to Lucid Diagnostics. The other authors had no competing interests to declare. Sloan disclosed speaking and/or advisory work for Sanofi-Regeneron, Phathom Pharmaceuticals, and Takeda Pharmaceuticals unrelated to his comments.
A version of this article appeared on Medscape.com.