{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,18]],"date-time":"2026-07-18T00:22:22Z","timestamp":1784334142012,"version":"3.55.0"},"reference-count":20,"publisher":"Springer Science and Business Media LLC","issue":"3","license":[{"start":{"date-parts":[[2025,2,22]],"date-time":"2025-02-22T00:00:00Z","timestamp":1740182400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2025,2,22]],"date-time":"2025-02-22T00:00:00Z","timestamp":1740182400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100024159","name":"Dr. Reddy's Laboratories","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100024159","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Indian J Gastroenterol"],"published-print":{"date-parts":[[2025,6]]},"abstract":"<jats:title>Abstract<\/jats:title>\n          <jats:sec>\n            <jats:title>Background<\/jats:title>\n            <jats:p>Elobixibat is a locally acting ileal bile acid transporter (IBAT) inhibitor that relieves functional constipation in patients by accelerating colonic transit. In this study, we aimed at determining the efficacy and safety of elobixibat for short-term treatment (two\u00a0weeks) of chronic constipation in Indian patients.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Methods<\/jats:title>\n            <jats:p>The present study was a randomized, double-blind, parallel-group, placebo-controlled, phase III study to evaluate efficacy and safety of elobixibat. The study planned to enroll patients with chronic constipation of at least six\u00a0months'\u00a0duration, satisfying Rome IV criteria for functional constipation. Following a run-in of approximately 14\u00a0days to confirm eligibility and determine baseline frequency of spontaneous bowel movements (SBMs), eligible patients were randomized 1:1 either to elobixibat or to placebo groups. The change in weekly frequency of spontaneous bowel movements (SBMs) at the end of treatment (week two) over baseline was the primary efficacy endpoint in this trial. Primary efficacy analyses were based on the modified intention-to-treat (mITT) population. This trial is registered at CTRI (Clinical Trial Registry of India).<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Results<\/jats:title>\n            <jats:p>Between April 2023 and December 2023, 150 patients were randomized into the two-week trial. In mITT population (<jats:italic>n<\/jats:italic>\u2009=\u2009146 [elobixibat\u2009=\u200975 and placebo\u2009=\u200971]), the least square mean (LSM) difference between elobixibat (3.83) and placebo (2.68) was 1.15 (95% CI, 0.31, 1.99) demonstrating a statistically significant improvement (<jats:italic>p<\/jats:italic>\u2009=\u20090.008) in weekly frequency of SBMs (week two over baseline) with the use of elobixibat. The proportions of patients with a\u00a0complete spontaneous bowel movement\u00a0(CSBM)\u00a0\u201cresponse\u201d was significantly higher with elobixibat (49.33%) compared to the placebo (26.76%) treatment (difference 22.57% [95% CI, 8.36%, 36.78%] [<jats:italic>p<\/jats:italic>\u2009=\u20090.005]). The most common adverse event (AE) was abdominal pain (elobixibat\u2009=\u20096 patients [7.89%] vs. placebo\u2009=\u20093 patients [4.05%]).<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusions<\/jats:title>\n            <jats:p>Elobixibat was well tolerated and improved bowel movement frequency within two\u00a0weeks of treatment in Indian patient population with chronic constipation.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Clinical trial registry number<\/jats:title>\n            <jats:p>CTRI\/2022\/10\/046690<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Graphical Abstract<\/jats:title>\n          <\/jats:sec>","DOI":"10.1007\/s12664-024-01719-7","type":"journal-article","created":{"date-parts":[[2025,2,22]],"date-time":"2025-02-22T08:54:34Z","timestamp":1740214474000},"page":"336-344","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Efficacy and safety of elobixibat in patients with chronic constipation\u2014A randomized, multicenter, double-blind, placebo-controlled, parallel-group study from India"],"prefix":"10.1007","volume":"44","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5078-6054","authenticated-orcid":false,"given":"Piyush","family":"Agarwal","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brajesh Kumar","family":"Jha","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jaganmohan","family":"Somagoni","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Srinivas Shenoy","family":"B","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vipul","family":"Modh","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sanketh Kumar","family":"Chakilam","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vinay","family":"Kumar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mukewar Shrikant","family":"Vasantrao","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mukesh","family":"Kalla","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anumula","family":"Kavitha","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Omesh","family":"Goyal","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ashima","family":"Bhatia","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,2,22]]},"reference":[{"key":"1719_CR1","doi-asserted-by":"publisher","first-page":"3","DOI":"10.1016\/j.bpg.2010.12.010","volume":"25","author":"SM Mugie","year":"2011","unstructured":"Mugie SM, Benninga MA, Di Lorenzo C. 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The authors VK, MSV, MK, AK and OG are the trial investigators and they declared that no competing interests exist. The authors VK, MSV, MK, AK and OG entered into a contract for the patient recruitment and clinical conduct of the study at their respective sites.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"The study was conducted in compliance with the ethical principles that originate in the Declaration of Helsinki and the International Conference on Harmonization (ICH) guidelines for good clinical practice (GCP). The study was approved by institutional ethics committee of each participating centers. Written informed consent was obtained from each patient prior to screening on the approved informed consent form (ICF). Patients received a defined conveyance allowance in the study but were not compensated in other manner. All authors had access to all data and take full responsibility for the submission.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical statements"}},{"value":"The authors are solely responsible for the data and the contents of the paper. In no way, the Honorary Editor-in-Chief, Editorial Board Members,\u00a0the Indian Society of Gastroenterology or the printer\/publishers are responsible for the results\/findings and content of this article","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Disclaimer"}}]}}