Pub Date : 2025-05-01Epub Date: 2025-02-12DOI: 10.1097/MOG.0000000000001084
Anna Pocurull, Sabela Lens
Purpose of review: This review highlights the critical considerations for monitoring patients who achieve sustained virological response (SVR) after direct-acting antiviral (DAA) therapy for hepatitis C virus (HCV) infection. Despite the remarkable success of DAAs, challenges persist in managing long-term risks, including hepatocellular carcinoma (HCC), liver decompensation, and extrahepatic manifestations, necessitating a tailored follow-up approach.
Recent findings: Recent studies emphasize that SVR does not eliminate risks for complications, particularly in patients with advanced fibrosis or cirrhosis. Advances in noninvasive tools, such as transient elastography and blood-based markers, have improved assessment of portal hypertension and liver function dynamics post-SVR. HCC surveillance remains critical for high-risk groups. Additionally, SVR improves extrahepatic conditions like mixed cryoglobulinemia and non-Hodgkin lymphoma, though careful monitoring for recurrence or associated risks is advised. Reinfection in high-risk populations underscores the importance of structured prevention and retreatment strategies.
Summary: Tailored follow-up of post-SVR patients remains essential. Future research should focus on refining predictive tools for late complications and optimizing surveillance strategies, balancing cost-effectiveness with clinical outcomes.
{"title":"The clinical challenge of managing patients after sustained virological response with direct-acting antivirals for Hepatitis C.","authors":"Anna Pocurull, Sabela Lens","doi":"10.1097/MOG.0000000000001084","DOIUrl":"10.1097/MOG.0000000000001084","url":null,"abstract":"<p><strong>Purpose of review: </strong>This review highlights the critical considerations for monitoring patients who achieve sustained virological response (SVR) after direct-acting antiviral (DAA) therapy for hepatitis C virus (HCV) infection. Despite the remarkable success of DAAs, challenges persist in managing long-term risks, including hepatocellular carcinoma (HCC), liver decompensation, and extrahepatic manifestations, necessitating a tailored follow-up approach.</p><p><strong>Recent findings: </strong>Recent studies emphasize that SVR does not eliminate risks for complications, particularly in patients with advanced fibrosis or cirrhosis. Advances in noninvasive tools, such as transient elastography and blood-based markers, have improved assessment of portal hypertension and liver function dynamics post-SVR. HCC surveillance remains critical for high-risk groups. Additionally, SVR improves extrahepatic conditions like mixed cryoglobulinemia and non-Hodgkin lymphoma, though careful monitoring for recurrence or associated risks is advised. Reinfection in high-risk populations underscores the importance of structured prevention and retreatment strategies.</p><p><strong>Summary: </strong>Tailored follow-up of post-SVR patients remains essential. Future research should focus on refining predictive tools for late complications and optimizing surveillance strategies, balancing cost-effectiveness with clinical outcomes.</p>","PeriodicalId":50607,"journal":{"name":"Current Opinion in Gastroenterology","volume":" ","pages":"116-121"},"PeriodicalIF":2.6,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143494484","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-05-01Epub Date: 2025-02-17DOI: 10.1097/MOG.0000000000001081
James Wild, Nicoletta Nandi, Thean Soon Chew, Benjamin Rea, Reena Sidhu
Purpose of review: Crohn's disease (CD), requires accurate diagnosis and regular monitoring to manage disease activity, prevent complications, and improve outcomes. Intestinal ultrasound (IUS) has emerged as a noninvasive, real-time imaging modality, offering a valuable alternative to traditional diagnostic techniques such as magnetic resonance enterography (MRE), endoscopy and capsule endoscopy (CE). This review examines recent advances in IUS for the diagnosis and monitoring of small bowel CD, with a focus on its applications, benefits, and limitations.
Recent findings: Recent studies have demonstrated that IUS provides high sensitivity and specificity in detecting key markers of disease activity, including bowel wall thickness (BWT), bowel wall flow (BWF), and bowel wall stratification (BWS). Advances in IUS techniques, such as elastography and contrast-enhanced ultrasound (CEUS), have expanded its diagnostic and prognostic capabilities, potentially enabling differentiation between inflammation and fibrosis. However, challenges remain, including operator dependency, variability in scoring systems, and reduced sensitivity for superficial mucosal abnormalities. Efforts to standardize parameters and improve training have shown promise in addressing these limitations.
Summary: IUS is a critical complementary tool for assessing disease activity, transmural healing, and postoperative recurrence in small bowel CD. Its noninvasiveness, cost-effectiveness, and real time assessment make it well suited for routine clinical use. Nonetheless, further multicentre studies are needed to validate scoring systems, optimize integration with other modalities, and improve consistency across clinical settings. IUS holds significant potential for advancing personalized care in small bowel CD, though ongoing research is required to refine its applications and maximize its clinical utility.
{"title":"Small bowel ultrasound: friend or foe?","authors":"James Wild, Nicoletta Nandi, Thean Soon Chew, Benjamin Rea, Reena Sidhu","doi":"10.1097/MOG.0000000000001081","DOIUrl":"10.1097/MOG.0000000000001081","url":null,"abstract":"<p><strong>Purpose of review: </strong>Crohn's disease (CD), requires accurate diagnosis and regular monitoring to manage disease activity, prevent complications, and improve outcomes. Intestinal ultrasound (IUS) has emerged as a noninvasive, real-time imaging modality, offering a valuable alternative to traditional diagnostic techniques such as magnetic resonance enterography (MRE), endoscopy and capsule endoscopy (CE). This review examines recent advances in IUS for the diagnosis and monitoring of small bowel CD, with a focus on its applications, benefits, and limitations.</p><p><strong>Recent findings: </strong>Recent studies have demonstrated that IUS provides high sensitivity and specificity in detecting key markers of disease activity, including bowel wall thickness (BWT), bowel wall flow (BWF), and bowel wall stratification (BWS). Advances in IUS techniques, such as elastography and contrast-enhanced ultrasound (CEUS), have expanded its diagnostic and prognostic capabilities, potentially enabling differentiation between inflammation and fibrosis. However, challenges remain, including operator dependency, variability in scoring systems, and reduced sensitivity for superficial mucosal abnormalities. Efforts to standardize parameters and improve training have shown promise in addressing these limitations.</p><p><strong>Summary: </strong>IUS is a critical complementary tool for assessing disease activity, transmural healing, and postoperative recurrence in small bowel CD. Its noninvasiveness, cost-effectiveness, and real time assessment make it well suited for routine clinical use. Nonetheless, further multicentre studies are needed to validate scoring systems, optimize integration with other modalities, and improve consistency across clinical settings. IUS holds significant potential for advancing personalized care in small bowel CD, though ongoing research is required to refine its applications and maximize its clinical utility.</p>","PeriodicalId":50607,"journal":{"name":"Current Opinion in Gastroenterology","volume":" ","pages":"154-163"},"PeriodicalIF":2.6,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143505759","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-05-01Epub Date: 2025-02-19DOI: 10.1097/MOG.0000000000001091
Dorien Pint, Yooyun Chung, Michael A Heneghan
Purpose of review: This review highlights the management, maternal and fetal outcomes, and the critical role of prepregnancy counseling for women with portal hypertension (PHT), a topic of growing clinical relevance as pregnancies in women with PHT have increased over the last two decades.
Recent findings: Pregnancy exacerbates PHT due to physiological changes that increase blood flow and vascular resistance, raising the risk of life-threatening complications like variceal bleeding. The distinction between noncirrhotic (NCPH) and cirrhotic portal hypertension (CPH) is essential, as maternal risks vary significantly.
Summary: Optimal care for women with PHT requires preconception counseling to assess risks, adjust medications, and plan necessary investigations such as variceal and splenic artery aneurysm screening and, if necessary, plan additional interventions. A multidisciplinary team - including hepatologists, obstetricians, anesthetists, and radiologists - is crucial for personalized management, addressing both the mode of delivery and peripartum care. While PHT complicates pregnancy, favorable outcomes are achievable with proactive planning and close follow-up during pregnancy.
{"title":"Portal hypertension in pregnancy.","authors":"Dorien Pint, Yooyun Chung, Michael A Heneghan","doi":"10.1097/MOG.0000000000001091","DOIUrl":"10.1097/MOG.0000000000001091","url":null,"abstract":"<p><strong>Purpose of review: </strong>This review highlights the management, maternal and fetal outcomes, and the critical role of prepregnancy counseling for women with portal hypertension (PHT), a topic of growing clinical relevance as pregnancies in women with PHT have increased over the last two decades.</p><p><strong>Recent findings: </strong>Pregnancy exacerbates PHT due to physiological changes that increase blood flow and vascular resistance, raising the risk of life-threatening complications like variceal bleeding. The distinction between noncirrhotic (NCPH) and cirrhotic portal hypertension (CPH) is essential, as maternal risks vary significantly.</p><p><strong>Summary: </strong>Optimal care for women with PHT requires preconception counseling to assess risks, adjust medications, and plan necessary investigations such as variceal and splenic artery aneurysm screening and, if necessary, plan additional interventions. A multidisciplinary team - including hepatologists, obstetricians, anesthetists, and radiologists - is crucial for personalized management, addressing both the mode of delivery and peripartum care. While PHT complicates pregnancy, favorable outcomes are achievable with proactive planning and close follow-up during pregnancy.</p>","PeriodicalId":50607,"journal":{"name":"Current Opinion in Gastroenterology","volume":" ","pages":"110-115"},"PeriodicalIF":2.6,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143505758","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-05-01Epub Date: 2025-02-13DOI: 10.1097/MOG.0000000000001083
Eda Kaya, Wing-Kin Syn, Paul Manka
Purpose of review: Obesity and type 2 diabetes mellitus (T2DM) are significant global health challenges, closely linked to metabolic dysfunction-associated steatotic liver disease (MASLD). Glucagon-like peptide-1 receptor agonists (GLP-1RAs) have shown promise in treating T2DM and obesity, but their potential for managing MASLD is still being explored. This review aims to examine the current progress in using GLP-1RAs for MASLD treatment and evaluate emerging dual and triple hormonal agonists as future therapeutic options.
Recent findings: GLP-1RAs have been effective in controlling blood sugar levels, promoting weight loss, and improving cardiovascular and kidney function. Furthermore, they have shown potential benefits for liver function in patients with MASLD. GLP-1, a key incretin hormone, influences glucose metabolism, appetite, and insulin sensitivity while affecting gastric emptying and potentially reducing fat deposition in the liver. Recent developments in GLP-1RAs include various formulations with different administration and dosing options, expanding their therapeutic use.
Summary: GLP-1RAs have become central to the management of T2DM, obesity, and possibly MASLD due to their ability to lower HbA1c, aid in weight reduction, and provide cardiovascular protection. As research continues, dual and triple hormonal agonists are emerging as the next evolution of incretin-based therapies, offering promising new strategies for addressing MASLD in the future.
{"title":"Glucagon like peptide-1 receptor agonists as a promising therapeutic option of metabolic dysfunction associated steatotic liver disease and obesity: hitting two targets with one shot.","authors":"Eda Kaya, Wing-Kin Syn, Paul Manka","doi":"10.1097/MOG.0000000000001083","DOIUrl":"10.1097/MOG.0000000000001083","url":null,"abstract":"<p><strong>Purpose of review: </strong>Obesity and type 2 diabetes mellitus (T2DM) are significant global health challenges, closely linked to metabolic dysfunction-associated steatotic liver disease (MASLD). Glucagon-like peptide-1 receptor agonists (GLP-1RAs) have shown promise in treating T2DM and obesity, but their potential for managing MASLD is still being explored. This review aims to examine the current progress in using GLP-1RAs for MASLD treatment and evaluate emerging dual and triple hormonal agonists as future therapeutic options.</p><p><strong>Recent findings: </strong>GLP-1RAs have been effective in controlling blood sugar levels, promoting weight loss, and improving cardiovascular and kidney function. Furthermore, they have shown potential benefits for liver function in patients with MASLD. GLP-1, a key incretin hormone, influences glucose metabolism, appetite, and insulin sensitivity while affecting gastric emptying and potentially reducing fat deposition in the liver. Recent developments in GLP-1RAs include various formulations with different administration and dosing options, expanding their therapeutic use.</p><p><strong>Summary: </strong>GLP-1RAs have become central to the management of T2DM, obesity, and possibly MASLD due to their ability to lower HbA1c, aid in weight reduction, and provide cardiovascular protection. As research continues, dual and triple hormonal agonists are emerging as the next evolution of incretin-based therapies, offering promising new strategies for addressing MASLD in the future.</p>","PeriodicalId":50607,"journal":{"name":"Current Opinion in Gastroenterology","volume":" ","pages":"104-109"},"PeriodicalIF":2.6,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143494480","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-05-01Epub Date: 2025-02-10DOI: 10.1097/MOG.0000000000001087
João Carlos Gonçalves, Bruno Rosa, José Cotter
Purpose of review: This article provides gastroenterologists with an overview of small bowel involvement in systemic vasculitis. Though various vasculitides can impact the small bowel, we highlight those with a more frequent and clinically significant GI involvement.
Recent findings: Recent advances, including increased accessibility to cross-sectional imaging, capsule endoscopy and device-assisted enteroscopy, have improved detection of gastrointestinal manifestations in systemic vasculitis. Studies have also explored the genetic and inflammatory pathways involved in these diseases, although high-quality evidence on diagnosis and treatment remains limited, leading to reliance on expert consensus.
Summary: Small bowel involvement is common in Behçet's disease and small vessel vasculitis, presenting with symptoms ranging from mild to severe, including massive bleeding, ischemia, and perforation, often indicating a poorer prognosis. Diagnosis is challenging, but in patients with a known or suspected history of vasculitis, it should prompt contrast-enhanced abdominal imaging and endoscopic evaluation. Treatment decisions should be made collaboratively by a multidisciplinary team, with immunosuppressive therapy remaining the cornerstone.
{"title":"Small bowel vasculitis? what a gastroenterologist should know - from diagnosis to management.","authors":"João Carlos Gonçalves, Bruno Rosa, José Cotter","doi":"10.1097/MOG.0000000000001087","DOIUrl":"10.1097/MOG.0000000000001087","url":null,"abstract":"<p><strong>Purpose of review: </strong>This article provides gastroenterologists with an overview of small bowel involvement in systemic vasculitis. Though various vasculitides can impact the small bowel, we highlight those with a more frequent and clinically significant GI involvement.</p><p><strong>Recent findings: </strong>Recent advances, including increased accessibility to cross-sectional imaging, capsule endoscopy and device-assisted enteroscopy, have improved detection of gastrointestinal manifestations in systemic vasculitis. Studies have also explored the genetic and inflammatory pathways involved in these diseases, although high-quality evidence on diagnosis and treatment remains limited, leading to reliance on expert consensus.</p><p><strong>Summary: </strong>Small bowel involvement is common in Behçet's disease and small vessel vasculitis, presenting with symptoms ranging from mild to severe, including massive bleeding, ischemia, and perforation, often indicating a poorer prognosis. Diagnosis is challenging, but in patients with a known or suspected history of vasculitis, it should prompt contrast-enhanced abdominal imaging and endoscopic evaluation. Treatment decisions should be made collaboratively by a multidisciplinary team, with immunosuppressive therapy remaining the cornerstone.</p>","PeriodicalId":50607,"journal":{"name":"Current Opinion in Gastroenterology","volume":" ","pages":"132-138"},"PeriodicalIF":2.6,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143494483","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-05-01Epub Date: 2025-02-12DOI: 10.1097/MOG.0000000000001088
Francesco Segatta, Silvia Paggi, Franco Radaelli, Emanuele Rondonotti
Purpose of review: Capsule endoscopy (CE) is an effective tool for small bowel evaluation. Recent technical advancements, including long-lasting batteries and enhanced optics, have enabled featured capsules (panenteric capsules, PCs) to potentially assess the entire gastrointestinal (GI) tract. The PC provides a potential easy-to-use, comprehensive, single-device approach for evaluating GI bleeding patients. This review critically examines the potential role of PC in patients with GI bleeding by highlighting benefits, limitations, open issues, and future challenges.
Recent findings: Evidence on PC for GI bleeding patients remains limited. Two retrospective studies and one recent prospective trial consistently show that when used in the workup of GI bleeding patients, PC is safe, feasible, achieves high diagnostic yield (both in the small and large bowel), and potentially reduces the need for unnecessary colonoscopies. Nevertheless, current challenges include the need for extensive bowel preparation, incomplete colon evaluation, and limited access to trained readers.
Summary: The PC holds promise for optimizing the diagnostic workup of GI bleeding patients. However, significant challenges remain. Robust clinical trials comparing standard diagnostic methods to PC-based workup are needed before the adoption of PC in managing bleeding patients in clinical practice.
审查目的:胶囊内镜(CE)是评估小肠的有效工具。最近的技术进步,包括长效电池和增强型光学技术,使特色胶囊(肠管胶囊,PC)有可能评估整个胃肠道(GI)。PC 为评估消化道出血患者提供了一种潜在的易用、全面的单设备方法。本综述通过强调PC的益处、局限性、未决问题和未来挑战,对PC在消化道出血患者中的潜在作用进行了批判性研究:消化道出血患者使用 PC 的证据仍然有限。两项回顾性研究和最近的一项前瞻性试验一致表明,PC 用于消化道出血患者的检查安全、可行、诊断率高(包括小肠和大肠),并有可能减少不必要的结肠镜检查。然而,目前面临的挑战包括:需要进行大量肠道准备、结肠评估不全面以及训练有素的读片人员有限。然而,目前仍存在重大挑战。在临床实践中采用 PC 对出血患者进行管理之前,需要进行可靠的临床试验,将标准诊断方法与基于 PC 的检查方法进行比较。
{"title":"Panenteric capsule endoscopy in gastrointestinal bleeding - time to change old habits?","authors":"Francesco Segatta, Silvia Paggi, Franco Radaelli, Emanuele Rondonotti","doi":"10.1097/MOG.0000000000001088","DOIUrl":"10.1097/MOG.0000000000001088","url":null,"abstract":"<p><strong>Purpose of review: </strong>Capsule endoscopy (CE) is an effective tool for small bowel evaluation. Recent technical advancements, including long-lasting batteries and enhanced optics, have enabled featured capsules (panenteric capsules, PCs) to potentially assess the entire gastrointestinal (GI) tract. The PC provides a potential easy-to-use, comprehensive, single-device approach for evaluating GI bleeding patients. This review critically examines the potential role of PC in patients with GI bleeding by highlighting benefits, limitations, open issues, and future challenges.</p><p><strong>Recent findings: </strong>Evidence on PC for GI bleeding patients remains limited. Two retrospective studies and one recent prospective trial consistently show that when used in the workup of GI bleeding patients, PC is safe, feasible, achieves high diagnostic yield (both in the small and large bowel), and potentially reduces the need for unnecessary colonoscopies. Nevertheless, current challenges include the need for extensive bowel preparation, incomplete colon evaluation, and limited access to trained readers.</p><p><strong>Summary: </strong>The PC holds promise for optimizing the diagnostic workup of GI bleeding patients. However, significant challenges remain. Robust clinical trials comparing standard diagnostic methods to PC-based workup are needed before the adoption of PC in managing bleeding patients in clinical practice.</p>","PeriodicalId":50607,"journal":{"name":"Current Opinion in Gastroenterology","volume":" ","pages":"139-145"},"PeriodicalIF":2.6,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143494481","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-05-01Epub Date: 2025-02-17DOI: 10.1097/MOG.0000000000001090
Tom van Gils, Magnus Simrén
Purpose of review: The role of gluten and wheat in irritable bowel syndrome (IBS) is unclear, whereas it plays a key-role in the diagnosis and treatment of noncoeliac gluten or wheat sensitivity (NCGWS). This review aims to provide the most recent insights in pathophysiological mechanisms and to summarize the evidence for a gluten- or wheat-free diet in IBS and NCGWS.
Recent findings: The exact role of gluten and wheat in IBS and NCGWS pathophysiological mechanisms remains complex. However, recent findings suggest a role for antigliadin antibodies to identify those IBS patients who may benefit from a gluten-free diet and low levels of fecal calprotectin to differentiate IBS and NCGWS. The importance of gut-brain interactions in self-reported gluten sensitive individuals was shown by a strong nocebo effect, although a role of gluten could not be excluded. Evidence for a gluten-free diet remains debatable in both conditions, whereas a wheat-free diet may have more potential, especially in NCGWS.
Summary: IBS and NCGWS are two closely related conditions with a complex and largely unrevealed pathophysiology. The role of gluten may have been overestimated in the past, but it is likely that certain wheat components, along with gut-brain interactions, play a role in both conditions.
{"title":"The role of gluten and wheat in irritable bowel syndrome and noncoeliac gluten or wheat sensitivity.","authors":"Tom van Gils, Magnus Simrén","doi":"10.1097/MOG.0000000000001090","DOIUrl":"10.1097/MOG.0000000000001090","url":null,"abstract":"<p><strong>Purpose of review: </strong>The role of gluten and wheat in irritable bowel syndrome (IBS) is unclear, whereas it plays a key-role in the diagnosis and treatment of noncoeliac gluten or wheat sensitivity (NCGWS). This review aims to provide the most recent insights in pathophysiological mechanisms and to summarize the evidence for a gluten- or wheat-free diet in IBS and NCGWS.</p><p><strong>Recent findings: </strong>The exact role of gluten and wheat in IBS and NCGWS pathophysiological mechanisms remains complex. However, recent findings suggest a role for antigliadin antibodies to identify those IBS patients who may benefit from a gluten-free diet and low levels of fecal calprotectin to differentiate IBS and NCGWS. The importance of gut-brain interactions in self-reported gluten sensitive individuals was shown by a strong nocebo effect, although a role of gluten could not be excluded. Evidence for a gluten-free diet remains debatable in both conditions, whereas a wheat-free diet may have more potential, especially in NCGWS.</p><p><strong>Summary: </strong>IBS and NCGWS are two closely related conditions with a complex and largely unrevealed pathophysiology. The role of gluten may have been overestimated in the past, but it is likely that certain wheat components, along with gut-brain interactions, play a role in both conditions.</p>","PeriodicalId":50607,"journal":{"name":"Current Opinion in Gastroenterology","volume":" ","pages":"164-174"},"PeriodicalIF":2.6,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143505760","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-03-01Epub Date: 2025-01-13DOI: 10.1097/MOG.0000000000001075
Donna M Evon, Bryce B Reeve
Purpose of review: Patient-reported outcome (PRO) measures validated in primary sclerosing cholangitis (PSC) are needed for clinical trials. This review describes the recent US Food & Drug Administration (FDA) Patient-Focused Drug Development (PFDD) guidelines, existing PRO measures used in PSC studies, and the design of PSC-specific symptom measures adherent with the guidelines.
Recent findings: FDA released updated guidance reflecting best practices for the design and evaluation of clinical outcome assessments (including PROs) and the design of trial endpoints. Two recent systematic reviews (2018, 2020) identified multiple PRO measures used in PSC studies, with two additional measures published since. Of these, four were developed in samples inclusive of PSC patients and six have been psychometrically evaluated in PSC. Published evidence to sufficiently support alignment with the recent guidance is sparse. We review the design of three symptom measures for PSC to illustrate alignment with FDA guidance, including qualitative and quantitative studies to provide evidence for their validity for use in adult PSC trials.
Summary: Investigators planning to use PRO measures as study endpoints for PSC need to be adherent with the recent FDA guidelines and build the evidence base to support the measure as fit-for-purpose as an endpoint for clinical trials.
{"title":"Assessing patient-reported outcomes in primary sclerosing cholangitis: an update.","authors":"Donna M Evon, Bryce B Reeve","doi":"10.1097/MOG.0000000000001075","DOIUrl":"10.1097/MOG.0000000000001075","url":null,"abstract":"<p><strong>Purpose of review: </strong>Patient-reported outcome (PRO) measures validated in primary sclerosing cholangitis (PSC) are needed for clinical trials. This review describes the recent US Food & Drug Administration (FDA) Patient-Focused Drug Development (PFDD) guidelines, existing PRO measures used in PSC studies, and the design of PSC-specific symptom measures adherent with the guidelines.</p><p><strong>Recent findings: </strong>FDA released updated guidance reflecting best practices for the design and evaluation of clinical outcome assessments (including PROs) and the design of trial endpoints. Two recent systematic reviews (2018, 2020) identified multiple PRO measures used in PSC studies, with two additional measures published since. Of these, four were developed in samples inclusive of PSC patients and six have been psychometrically evaluated in PSC. Published evidence to sufficiently support alignment with the recent guidance is sparse. We review the design of three symptom measures for PSC to illustrate alignment with FDA guidance, including qualitative and quantitative studies to provide evidence for their validity for use in adult PSC trials.</p><p><strong>Summary: </strong>Investigators planning to use PRO measures as study endpoints for PSC need to be adherent with the recent FDA guidelines and build the evidence base to support the measure as fit-for-purpose as an endpoint for clinical trials.</p>","PeriodicalId":50607,"journal":{"name":"Current Opinion in Gastroenterology","volume":" ","pages":"59-66"},"PeriodicalIF":2.6,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143015666","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}