Kira L Newman, Allen A Lee, Prashant Singh, John Y Kao, William D Chey, Peter D R Higgins
{"title":"Increases in Probiotic Supplement Use Exceed Microbiome-Focused Dietary Changes in United States Adults and Children.","authors":"Kira L Newman, Allen A Lee, Prashant Singh, John Y Kao, William D Chey, Peter D R Higgins","doi":"10.1016/j.cgh.2026.08.029","DOIUrl":"10.1016/j.cgh.2026.08.029","url":null,"abstract":"","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":" ","pages":""},"PeriodicalIF":16.2,"publicationDate":"2026-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148904529","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Francisca Joly, Tim Vanuytsel, Donald F Kirby, Simon Lal, Kelly Tappenden, Palle B Jeppesen, Robert Venick, Marek Kunecki, Kinga Szczepanek, Przemysław Matras, Carrie Li, Tomasz Masior, Patricia Valencia, Mena Boules, Kishore R Iyer
{"title":"STARS Phase 3 Trial: Once-Weekly Apraglutide Reduces Parenteral Support in Short Bowel Syndrome-Intestinal Failure.","authors":"Francisca Joly, Tim Vanuytsel, Donald F Kirby, Simon Lal, Kelly Tappenden, Palle B Jeppesen, Robert Venick, Marek Kunecki, Kinga Szczepanek, Przemysław Matras, Carrie Li, Tomasz Masior, Patricia Valencia, Mena Boules, Kishore R Iyer","doi":"10.1016/j.cgh.2026.08.026","DOIUrl":"10.1016/j.cgh.2026.08.026","url":null,"abstract":"<p><strong>Background & aims: </strong>Patients with short bowel syndrome and intestinal failure (SBS-IF) depend on parenteral support (PS) to meet nutritional and fluid requirements. Apraglutide, a once-weekly, long-acting glucagon-like peptide-2 analog, promotes intestinal adaptation and may reduce PS dependence. The phase 3 STARS trial evaluated the efficacy and safety of apraglutide vs placebo in SBS-IF.</p><p><strong>Methods: </strong>In this global, phase 3, double-blind, placebo-controlled trial, eligible patients were randomized 2:1 to once-weekly subcutaneous apraglutide or placebo, stratified by remnant intestinal anatomy (stoma or colon-in-continuity [CIC]). The primary end point was relative change from baseline in weekly PS volume at week 24 in the overall population. Key secondary end points included relative PS volume change in the stoma subgroup, days off PS (overall and CIC), and enteral autonomy (CIC). A safety analysis was conducted.</p><p><strong>Results: </strong>Overall, 163 patients (80 stoma, 83 CIC) were randomized and dosed. Apraglutide significantly reduced weekly PS volume from baseline vs placebo at week 24 in the overall population (mean relative change, -25.5% vs -12.5%; P = .001) and stoma subgroup (-25.6% vs -7.8%; P < .001). A higher proportion of patients receiving apraglutide vs placebo achieved a reduction of ≥1 day/week of PS at week 24 (43.0% vs 27.5%; P = .040). At week 48 (CIC), in the apraglutide vs placebo arms, the proportions of patients achieving a reduction of ≥1 day/week of PS and enteral autonomy were 51.8% vs 44.4% (P = .348) and 12.5% vs 7.4% (nominal P = .387), respectively. Apraglutide was well-tolerated with a favorable safety profile.</p><p><strong>Conclusions: </strong>Once-weekly subcutaneous apraglutide significantly reduced PS requirements in patients with SBS-IF with a well-tolerated safety profile.</p><p><strong>Clinicaltrials: </strong>gov, Number: NCT04627025. ClinicalTrialsRegister.eu, Number: 2020-001202-32.</p>","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":" ","pages":""},"PeriodicalIF":16.2,"publicationDate":"2026-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148886628","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jennifer D Claytor, Anna-Teresa D'Hooghe, Arno R Bourgonje, Susanne Ibing, Sayali Talware, Palak Rajauria, Chad Porter, Jean-Frédéric Colombel, James Ferrara, John E Levine, Bram Verstockt, Louis Cohen, Ryan C Ungaro
{"title":"Regenerating Islet-Derived 3α Is a Predictive Biomarker of Complicated Disease From Preclinical Through Established Crohn's Disease.","authors":"Jennifer D Claytor, Anna-Teresa D'Hooghe, Arno R Bourgonje, Susanne Ibing, Sayali Talware, Palak Rajauria, Chad Porter, Jean-Frédéric Colombel, James Ferrara, John E Levine, Bram Verstockt, Louis Cohen, Ryan C Ungaro","doi":"10.1016/j.cgh.2026.08.028","DOIUrl":"10.1016/j.cgh.2026.08.028","url":null,"abstract":"<p><strong>Background & aims: </strong>Regenerating islet-derived 3α (REG3α) is a serum biomarker in patients with graft-vs-host disease linked to 6-month mortality. REG3α is produced by intestinal Paneth cells, which are implicated in Crohn's disease (CD) pathophysiology. The aim of this study was to assess associations between serum REG3α and progressive CD.</p><p><strong>Methods: </strong>Serum REG3α was measured in 2 cross-sectional (Mount Sinai, Leuven) and a prediagnostic cohort (PREDICTS) with serial samples up to 10 years before CD diagnosis. Tissue REG3α expression was assessed via bulk RNA sequencing from paired ileal and colonic biopsies. Serum REG3α and tissue REG3α were associated with CD progression (hospitalization, surgery, steroid course, or new advanced therapy). Single-cell RNA sequencing data explored associations between REG3α expression, Paneth cell phenotypes, and CD.</p><p><strong>Results: </strong>In 394 patients, high serum REG3α was associated with CD progression, independent of C-reactive protein and endoscopic activity (Mt Sinai: hazard ratio [HR], 1.9; (95% confidence interval [CI], 1.3-2.8; Leuven: HR, 2.9; 95% CI, 1.9-4.6; both P < .001). The association persisted in patients with mild or inactive CD. In the prediagnostic cohort, high serum REG3α predicted the development of CD, particularly complicated (B2/3) and surgical presentations, up to 10 years before diagnosis (P). Analysis of REG3α expression and Paneth cell transcriptomes suggested that CD is associated with loss of regenerative Paneth cell populations and enrichment in REG3α-expressing populations, suggesting a mechanism through which changes in serum REG3α associate with complicated CD.</p><p><strong>Conclusions: </strong>Serum REG3α holds potential as a noninvasive, prognostic biomarker in CD, independent of disease activity. High serum REG3α, even years before diagnosis, is linked to a complicated disease course.</p>","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":" ","pages":""},"PeriodicalIF":16.2,"publicationDate":"2026-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148879408","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Mohamed Attauabi, Gorm R Madsen, Jakob Møller, Yousef J W Nielsen, Annette B Jensen, Hartwig R Siebner, Eva Fallentin, Flemming Bendtsen, Jakob B Seidelin, Johan Burisch
{"title":"Radiological Primary Sclerosing Cholangitis in Incident Inflammatory Bowel Disease - A Prospective Copenhagen Inflammatory Bowel Disease Inception Cohort Study.","authors":"Mohamed Attauabi, Gorm R Madsen, Jakob Møller, Yousef J W Nielsen, Annette B Jensen, Hartwig R Siebner, Eva Fallentin, Flemming Bendtsen, Jakob B Seidelin, Johan Burisch","doi":"10.1016/j.cgh.2026.08.027","DOIUrl":"10.1016/j.cgh.2026.08.027","url":null,"abstract":"<p><strong>Background & aims: </strong>Primary sclerosing cholangitis (PSC) is a chronic liver disease associated with long-term ulcerative colitis (UC) and Crohn's disease (CD). We aimed to determine its prevalence, clinical features, and impact in patients with newly diagnosed UC and CD.</p><p><strong>Methods: </strong>In a prospective population-based inception cohort, all adult patients with newly diagnosed UC or CD in a defined region of Denmark (2021-2023) were offered magnetic resonance cholangiopancreatography (MRCP). Primary outcome was the prevalence of radiological PSC. Patients were followed-up prospectively for a median of 2.0 years (interquartile range, 1.6-2.0 years; range, 1.0-2.0 years).</p><p><strong>Results: </strong>Of 527 patients, 389 patients (73.8%) (UC, 242; CD, 147) underwent MRCP, of whom 31 patients (8.0%) were diagnosed with radiological PSC (UC, 16 [6.6%]; CD, 15 [10.2%]), whereas 7 patients (1.8%; UC, 5 [2.1%]; CD, 2 [1.4%]) had nondiagnostic PSC-like lesions, yielding a combined prevalence of 9.8%. Only 51.6% (16/31) presented with abnormal liver biochemistry. PSC prevalence was higher in patients with extensive colitis (9/73 [12.3%] vs 7/164 [4.3%]; P = .02), but did not differ by age or sex, and was associated with higher rates of inflammatory bowel disease (IBD)-related hospitalization (41.9% vs 23.4%; P = .03) and biological therapies (38.7% vs 21.4%; P = .03) during follow-up.</p><p><strong>Conclusions: </strong>Radiological PSC or PSC-like lesions were present in 1 in 10 patients with incident IBD, often without biochemical abnormalities. These findings suggest a higher burden of radiological PSC at IBD onset than previously anticipated, although the long-term clinical significance remains uncertain. Although MRCP at IBD diagnosis may prove clinically beneficial, confirmation from long-term follow-up and cost-effectiveness analyses is required before it can be recommended for screening.</p>","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":" ","pages":""},"PeriodicalIF":16.2,"publicationDate":"2026-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148879401","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Christian von Muhlenbrock, Aleks Israelyan, Tim Vanuytsel
{"title":"Should We Abandon Nortriptyline for Functional Dyspepsia? Lessons From the TENDER Trial.","authors":"Christian von Muhlenbrock, Aleks Israelyan, Tim Vanuytsel","doi":"10.1016/j.cgh.2026.08.023","DOIUrl":"10.1016/j.cgh.2026.08.023","url":null,"abstract":"","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":" ","pages":""},"PeriodicalIF":16.2,"publicationDate":"2026-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148879435","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Rahul S. Dalal,Mia E. Silvestri,Karen M. Kwaning,Alex D. Carlin,Emma L. McClure,Jessica R. Allegretti
{"title":"Guselkumab Versus Risankizumab for Ulcerative Colitis: Real-World Comparison of Post-Induction Outcomes","authors":"Rahul S. Dalal,Mia E. Silvestri,Karen M. Kwaning,Alex D. Carlin,Emma L. McClure,Jessica R. Allegretti","doi":"10.1016/j.cgh.2026.09.018","DOIUrl":"https://doi.org/10.1016/j.cgh.2026.09.018","url":null,"abstract":"","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":"21 1","pages":""},"PeriodicalIF":12.6,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149020082","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}