{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,1]],"date-time":"2025-12-01T11:30:32Z","timestamp":1764588632155,"version":"3.38.0"},"reference-count":38,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2025,2,2]],"date-time":"2025-02-02T00:00:00Z","timestamp":1738454400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Aliment Pharmacol Ther"],"published-print":{"date-parts":[[2025,3]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Surrogate endpoints such as laboratory parameters that are not direct measurements of, but predict, clinical benefit are approved by regulatory agencies for initial proof of efficacy. No surrogate endpoints are approved for disorders of gut\u2013brain interaction.<\/jats:p><\/jats:sec><jats:sec><jats:title>Aim<\/jats:title><jats:p>To assess the correlation of scintigraphic colonic transit (CT) with response rates according to patient\u2010reported symptom\u2010based endpoints (composite\/global symptoms, abdominal pain or stool frequency\/consistency) in irritable bowel syndrome (IBS) or chronic idiopathic constipation (CIC).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We reviewed available data from, randomised controlled trials (RCTs) reporting effects on CT at 24\u2009h and 48\u2009h with drug versus placebo and extracted the difference in the proportions responding to drug or placebo, using rates from individual RCTs or from meta\u2010analyses when more than one RCT existed for a drug. We analysed associations between differences (drug vs. placebo) in CT and in response rates using Spearman correlation. Additional analyses of CT at 24\u2009h with composite\/global symptom or pain endpoints were performed with exclusion of alosetron (the only drug slowing CT).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>CT at 24\u2009h correlated significantly with composite\/global symptom endpoints (Rs\u2009=\u2009\u22120.755, <jats:italic>p<\/jats:italic>\u2009=\u20090.021). CT correlated with stool frequency or consistency (at 24\u2009h, Rs\u2009=\u20090.506, <jats:italic>p<\/jats:italic>\u2009=\u20090.074; at 48\u2009h, Rs\u2009=\u20090.631, <jats:italic>p<\/jats:italic>\u2009=\u20090.026). CT at 24\u2009h did not correlate with abdominal pain (Rs\u2009=\u2009\u22120.054, <jats:italic>p<\/jats:italic>\u2009=\u20090.843). With the exclusion of alosetron data, CT at 24\u2009h was non\u2010significantly correlated with the composite\/global symptom endpoint (Rs\u2009=\u2009\u22120.667, <jats:italic>p<\/jats:italic>\u2009=\u20090.073), but not with abdominal pain (Rs\u2009=\u20090.377, <jats:italic>p<\/jats:italic>\u2009=\u20090.419).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Scintigraphic CT measurement fulfils the expectation of a surrogate endpoint for symptom\u2010based outcomes, particularly in IBS\u2010D or IBS\u2010C and CIC.<\/jats:p><\/jats:sec>","DOI":"10.1111\/apt.18527","type":"journal-article","created":{"date-parts":[[2025,2,3]],"date-time":"2025-02-03T04:49:56Z","timestamp":1738558196000},"page":"950-958","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Review Article: Surrogate Endpoints to Assess Treatment Efficacy in Disorders of Gut\u2013Brain Interaction of Lower Gastrointestinal Tract"],"prefix":"10.1111","volume":"61","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6472-7514","authenticated-orcid":false,"given":"Michael","family":"Camilleri","sequence":"first","affiliation":[{"name":"Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Division of Gastroenterology and Hepatology Mayo Clinic  Rochester Minnesota USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6371-4359","authenticated-orcid":false,"given":"Alexander C.","family":"Ford","sequence":"additional","affiliation":[{"name":"Leeds Gastroenterology Institute, Leeds Teaching Hospitals National Health Service Trust, Leeds Institute of Medical Research at St. James's University of Leeds  Leeds 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