{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,12]],"date-time":"2026-06-12T20:46:11Z","timestamp":1781297171211,"version":"3.54.1"},"reference-count":25,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2025,11,10]],"date-time":"2025-11-10T00:00:00Z","timestamp":1762732800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J of Gastro and Hepatol"],"published-print":{"date-parts":[[2025,12]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background and Aim<\/jats:title>\n                    <jats:p>Irritable bowel syndrome with constipation (IBS\u2010C) is characterized by multiple sensory symptoms, including abdominal pain, bloating, and bowel habit alterations. Therapeutic response should address all components. This study assesses a new exploratory trisymptom composite efficacy endpoint in an IBS\u2010C population of young adults with bloating treated with plecanatide.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Pooled data were analyzed from two phase 3, randomized, double\u2010blind trials. Patients (18\u201340\u2009years) with IBS\u2010C and baseline bloating (score\u2009\u2265\u20091) received plecanatide 3\u2009mg or placebo for 12\u2009weeks. The composite response definition was simultaneous improvement from baseline in three symptoms (abdominal pain, bloating, and complete spontaneous bowel movements [CSBMs]\/week) for \u2265\u20096 of 12\u2009weeks using several thresholds (\u2265\u20092\u2010point or \u2265\u200930% or \u2265\u200940% improvement in abdominal pain and bloating plus an increase of \u2265\u20091 or \u2265\u20092 CSBMs in the same week).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Six hundred and five adults were included (plecanatide [\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009313]; placebo [\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009292]). Plecanatide\/placebo baseline mean symptom scores were 6.2\/6.4 for abdominal pain and 6.4\/6.6 for bloating; both had a mean of 0.2 CSBMs\/week. Significantly more patients in plecanatide versus placebo groups (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009\u2264\u20090.01 for all comparisons) were trisymptom composite responders by several stringent thresholds, including \u2265\u200930% improvement in pain and bloating plus \u2265\u20091 CSBM\/week increase (23.3% vs. 13.4%;\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.002) and \u2265\u200930% improvement in pain and bloating plus \u2265\u20092 CSBMs\/week increase (19.5% vs. 8.9%;\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.001). Plecanatide was well tolerated.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Plecanatide simultaneously and significantly improved combined symptoms of abdominal pain, bloating, and CSBM frequency at varying thresholds. Plecanatide is effective in improving global IBS\u2010C symptoms in individuals with bloating.<\/jats:p>\n                    <jats:p>\n                      <jats:bold>Trial Registration:<\/jats:bold>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/ClinicalTrials.gov\">ClinicalTrials.gov<\/jats:ext-link>\n                      identifiers\u2014NCT02387359 and NCT02493452.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/jgh.70119","type":"journal-article","created":{"date-parts":[[2025,11,11]],"date-time":"2025-11-11T04:08:06Z","timestamp":1762834086000},"page":"2890-2897","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["The Effectiveness of Plecanatide for Treating Constipation and Bloating in Patients Aged 18 to 40\u2009Years With Irritable Bowel Syndrome: Utilization of a New Composite Trisymptom Endpoint"],"prefix":"10.1111","volume":"40","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8577-7278","authenticated-orcid":false,"given":"Darren\u00a0M.","family":"Brenner","sequence":"first","affiliation":[{"name":"Internal Medicine\u2010Gastroenterology Northwestern University\u2013Feinberg School of Medicine  Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea\u00a0S.","family":"Shin","sequence":"additional","affiliation":[{"name":"Vatche and Tamar Manoukian Division of Digestive Diseases, Department of Medicine University of California, Los Angeles  Los Angeles California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adam\u00a0P.","family":"Laitman","sequence":"additional","affiliation":[{"name":"Salix Pharmaceuticals  Bridgewater New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jill\u00a0K.","family":"Deutsch","sequence":"additional","affiliation":[{"name":"Section of Digestive Diseases, Department of Internal Medicine Yale School of Medicine  New Haven Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David\u00a0C.","family":"Kunkel","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology University of California San Diego  La Jolla California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,11,10]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2016.02.031"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2012.02.029"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2019.12.021"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2023.05.049"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1093\/jcag\/gwad028"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/nmo.14903"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13030-016-0070-8"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2036.2009.04080.x"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2008.07.008"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/nmo.12758"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2020.03.056"},{"key":"e_1_2_10_13_1","unstructured":"Salix Pharmaceuticals.Trulance Tablets for Oral Use [Package Insert].2024."},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41395-018-0026-7"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1038\/ajg.2016.611"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1177\/1756283X17734697"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10620-024-08330-y"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.5056\/jnm15167"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2020.04.014"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10620-018-5352-5"},{"key":"e_1_2_10_21_1","unstructured":"US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research.Guidance for Industry: Irritable Bowel Syndrome\u2014Clinical Evaluation of Drugs for Treatment. accessed February 21 2025 http:\/\/www.fda.gov\/downloads\/Drugs\/Guidances\/UCM205269.pdf."},{"key":"e_1_2_10_22_1","doi-asserted-by":"publisher","DOI":"10.1111\/apt.13807"},{"key":"e_1_2_10_23_1","doi-asserted-by":"publisher","DOI":"10.14309\/ajg.0000000000001334"},{"key":"e_1_2_10_24_1","doi-asserted-by":"publisher","DOI":"10.14309\/ajg.0000000000002685"},{"key":"e_1_2_10_25_1","doi-asserted-by":"publisher","DOI":"10.1111\/nmo.14229"},{"key":"e_1_2_10_26_1","doi-asserted-by":"publisher","DOI":"10.1111\/jgh.16925"}],"container-title":["Journal of Gastroenterology and 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