{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T19:49:01Z","timestamp":1791316141594,"version":"4.3.1"},"reference-count":32,"publisher":"Oxford University Press (OUP)","issue":"8","license":[{"start":{"date-parts":[[2025,1,25]],"date-time":"2025-01-25T00:00:00Z","timestamp":1737763200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100004914","name":"Ferring Pharmaceuticals","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100004914","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,8,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Fecal microbiota, live-jslm (RBL; REBYOTA\u00ae), is the first single-dose, broad consortia, microbiota-based live biotherapeutic approved by the US Food and Drug Administration to prevent recurrent Clostridioides difficile infection (rCDI) in adults following standard-of-care antimicrobials. Inflammatory bowel disease (IBD) is a common risk factor for rCDI, yet patients with IBD are often excluded from prospective trials. This subgroup analysis of PUNCH CD3-OLS (NCT03931941) evaluated the safety and efficacy of RBL in participants with rCDI and IBD.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Participants with IBD (ulcerative colitis [UC], Crohn\u2019s disease [CD], or unspecified) who had rCDI were included. Treatment-emergent adverse event (TEAE) data were collected for up to 6 months following RBL administration. Efficacy outcomes included treatment success at 8 weeks and sustained clinical response at 6 months.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Overall, 793 participants were enrolled, and 697 received RBL; 74 had IBD (UC: n\u2005=\u200545; CD: n\u2005=\u200525; unspecified IBD: n\u2005=\u20054). TEAEs within 8 weeks of administration were reported by 45.9% and 47.5% of participants with and without IBD, respectively; most were mild or moderate gastrointestinal symptoms. Serious TEAEs within 8 weeks of administration were reported by 1.4% and 4.2% of participants with and without IBD, respectively. The treatment success rate at 8 weeks was 78.9%, and the sustained clinical response rate at 6 months was 91.1% in participants with IBD, similar to rates in participants without IBD (73.2% and 91.0%, respectively).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>The results of this subgroup analysis of PUNCH CD3-OLS suggest RBL is safe and efficacious in patients with IBD.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/ibd\/izae291","type":"journal-article","created":{"date-parts":[[2025,1,25]],"date-time":"2025-01-25T11:31:50Z","timestamp":1737804710000},"page":"2112-2122","source":"Crossref","is-referenced-by-count":19,"title":["Safety and Efficacy of Fecal Microbiota, Live-jslm (REBYOTA\u00ae), for the Prevention of Recurrent <i>Clostridioides difficile<\/i> Infection in Participants With Inflammatory Bowel Disease in PUNCH CD3-OLS"],"prefix":"10.1093","volume":"31","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3585-2425","authenticated-orcid":false,"given":"Jessica R","family":"Allegretti","sequence":"first","affiliation":[{"name":"Division of Gastroenterology, Hepatology and Endoscopy, Department of Medicine, Brigham & Women\u2019s Hospital , Boston, MA ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7643-9576","authenticated-orcid":false,"given":"Paul","family":"Feuerstadt","sequence":"additional","affiliation":[{"name":"Division of Digestive Disease, Yale University School of Medicine , New Haven, CT ,","place":["USA"]},{"name":"PACT-Gastroenterology Center , Hamden, CT ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Whitfield L","family":"Knapple","sequence":"additional","affiliation":[{"name":"Arkansas Gastroenterology , North Little Rock, AR ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"Orenstein","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Department of Internal Medicine, Mayo Clinic , Phoenix, AZ ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philippe","family":"Pinton","sequence":"additional","affiliation":[{"name":"Global Research and Medical, Ferring Pharmaceuticals A\/S , Kastrup ,","place":["Denmark"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexander","family":"Sheh","sequence":"additional","affiliation":[{"name":"Ferring Pharmaceuticals, Inc. , Roseville, MN ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sahil","family":"Khanna","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, Mayo Clinic , Rochester, MN 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