{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,27]],"date-time":"2026-09-27T02:05:53Z","timestamp":1790474753840,"version":"4.1.0"},"reference-count":50,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2023,1,1]],"date-time":"2023-01-01T00:00:00Z","timestamp":1672531200000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100003122","name":"Ferring","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100003122","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Therap Adv Gastroenterol"],"published-print":{"date-parts":[[2023,1]]},"abstract":"<jats:sec><jats:title>Background:<\/jats:title><jats:p> Microbiota-based treatments reduce the incidence of recurrent Clostridioides difficile infections (rCDIs), but prospectively collected safety data needed to broaden patient access and protect public health have been limited. <\/jats:p><\/jats:sec><jats:sec><jats:title>Objectives:<\/jats:title><jats:p> We provide cumulative safety data from five prospective clinical trials evaluating fecal microbiota, live-jslm (RBL) \u2013 the first microbiota-based live biotherapeutic product approved by the US Food and Drug Administration \u2013 for preventing rCDI in adults. <\/jats:p><\/jats:sec><jats:sec><jats:title>Design:<\/jats:title><jats:p> Integrated safety analysis includes three phase II trials (PUNCH CD, PUNCH CD2, PUNCH Open-Label) and two phase III trials (PUNCH CD3, PUNCH CD3-OLS) of RBL. <\/jats:p><\/jats:sec><jats:sec><jats:title>Methods:<\/jats:title><jats:p> Trial participants were at least 18\u2009years of age with documented rCDI who completed standard-of-care antibiotic therapy before treatment with RBL. Assigned study treatment regimen was one or two doses of RBL (or placebo) administered rectally, depending on the trial design. In four of the five trials, participants with CDI recurrence within 8\u2009weeks after RBL or placebo administration were eligible for treatment with open-label RBL. Treatment-emergent adverse events (TEAEs) were recorded for at least 6\u2009months following last study treatment; in PUNCH CD2 and PUNCH Open-Label trials, TEAEs and serious TEAEs were collected through 12 and 24\u2009months, respectively. <\/jats:p><\/jats:sec><jats:sec><jats:title>Results:<\/jats:title><jats:p> Among the five trials, 978 participants received at least one dose of RBL (assigned treatment or after recurrence) and 83 participants received placebo only. TEAEs were reported in 60.2% of Placebo Only participants and 66.4% of RBL Only participants. Only abdominal pain, nausea, and flatulence were significantly higher in the RBL Only group compared with the Placebo Only group. Most TEAEs were mild or moderate in severity and were most frequently related to preexisting conditions. There were no reported infections for which the causative pathogen was traced to RBL. Potentially life-threatening TEAEs were infrequent (3.0% of participants). <\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion:<\/jats:title><jats:p> Across five clinical trials, RBL was well tolerated in adults with rCDI. In aggregate, these data consistently demonstrated the safety of RBL. <\/jats:p><\/jats:sec>","DOI":"10.1177\/17562848231174277","type":"journal-article","created":{"date-parts":[[2023,6,12]],"date-time":"2023-06-12T12:21:10Z","timestamp":1686572470000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":71,"title":["Safety of fecal microbiota, live-jslm (REBYOTA<sup>\u2122<\/sup>) in individuals with recurrent <i>Clostridioides difficile<\/i> infection: data from five prospective clinical trials"],"prefix":"10.1177","volume":"16","author":[{"given":"Christine","family":"Lee","sequence":"first","affiliation":[{"name":"Medical Microbiologist and Researcher, Island Health, Clinical Professor, Department of Pathology and Laboratory Medicine, The University of British Columbia Faculty of Medicine, Vancouver, BC V6T 1Z3, Canada"},{"name":"Island Medical Program University of British Columbia, University of Victoria, 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