{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,21]],"date-time":"2026-07-21T03:09:31Z","timestamp":1784603371728,"version":"3.55.0"},"reference-count":26,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2025,10,1]],"date-time":"2025-10-01T00:00:00Z","timestamp":1759276800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2025,10,1]],"date-time":"2025-10-01T00:00:00Z","timestamp":1759276800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"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":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Therap Adv Gastroenterol"],"published-print":{"date-parts":[[2025,10]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>\n                      Fecal microbiota, live-jslm (RBL) is a microbiota-based product for the prevention of recurrent\n                      <jats:italic toggle=\"yes\">Clostridioides difficile<\/jats:italic>\n                      infection (rCDI) in adults following antibiotic treatment. The safety and clinical effectiveness of RBL administered via colonoscopy in adults with rCDI were evaluated in CDI-SCOPE. An 8-week analysis showed 9.8% of participants had RBL-related treatment-emergent adverse events (TEAEs; primary endpoint) and 95.1% experienced treatment success (no CDI recurrence).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives:<\/jats:title>\n                    <jats:p>To evaluate long-term safety and clinical effectiveness of RBL through 6 months of follow-up in CDI-SCOPE.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design:<\/jats:title>\n                    <jats:p>Single-arm exploratory phase IIIb trial conducted at 12 sites in the United States.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>Eligible adults with rCDI received a single 150-mL dose of RBL to the right colon via colonoscopy. The primary endpoint was RBL-related TEAEs through 8 weeks after RBL administration or confirmed treatment failure. Secondary endpoints included safety up to 6 months after RBL administration. Exploratory analyses included assessment of further CDI episodes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>Of the 41 participants enrolled, 39 completed trial assessments through 6 months. From 8 weeks through 6 months after RBL administration, 36 TEAEs in 15 participants (36.6%) were reported, one of which (irritable bowel syndrome) was RBL-related; most TEAEs (97.2%) were of mild or moderate severity. Over the 6-month trial period, 23 participants (56.1%) experienced 69 TEAEs; 94.2% were of mild or moderate severity. Serious TEAEs occurred in three participants (7.3%), none of which were related to RBL or its administration, and no TEAEs led to discontinuation or death. Overall, 38 participants (92.7%) did not experience further CDI episodes, 1 (2.4%) did between 8 weeks and 6 months, and 2 (4.9%) had an indeterminate outcome due to trial withdrawal before 8 weeks.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>RBL administered via colonoscopy was safe and effective for preventing CDI recurrence in adults with rCDI in CDI-SCOPE.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration:<\/jats:title>\n                    <jats:p>ClinicalTrials.gov: NCT05831189.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/17562848251396744","type":"journal-article","created":{"date-parts":[[2025,11,10]],"date-time":"2025-11-10T07:02:26Z","timestamp":1762758146000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":4,"title":["Prevention of recurrent\n                    <i>Clostridioides difficile<\/i>\n                    infection by fecal microbiota, live-jslm (REBYOTA\n                    <sup>\u00ae<\/sup>\n                    ) administered via colonoscopy: 6-month data from the single-arm phase IIIb CDI-SCOPE trial"],"prefix":"10.1177","volume":"18","author":[{"given":"Sahil","family":"Khanna","sequence":"first","affiliation":[{"name":"Mayo Clinic, Rochester, 200 First St SW, Rochester, MN 55905, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Yoho","sequence":"additional","affiliation":[{"name":"Mid-Atlantic Permanente Medical Group, Springfield, VA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Van Handel","sequence":"additional","affiliation":[{"name":"MNGI Digestive Health, Minneapolis, MN, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian J.","family":"Clark","sequence":"additional","affiliation":[{"name":"Ferring Pharmaceuticals A\/S, Copenhagen, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tahany","family":"Awad","sequence":"additional","affiliation":[{"name":"Ferring Pharmaceuticals A\/S, Copenhagen, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Beth","family":"Guthmueller","sequence":"additional","affiliation":[{"name":"Ferring Pharmaceuticals, Inc., Parsippany, NJ, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Armandi","sequence":"additional","affiliation":[{"name":"Ferring Pharmaceuticals A\/S, Copenhagen, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-4081-3304","authenticated-orcid":false,"given":"Whitfield","family":"Knapple","sequence":"additional","affiliation":[{"name":"Arkansas Gastroenterology, North Little Rock, AR, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nasia","family":"Safdar","sequence":"additional","affiliation":[{"name":"University of Wisconsin, Madison, WI, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian","family":"Baggott","sequence":"additional","affiliation":[{"name":"Cleveland Clinic, Cleveland, OH, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karen","family":"Simon","sequence":"additional","affiliation":[{"name":"Om Research, Camarillo, CA, 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":"PACT Gastroenterology Center, Yale School of Medicine, Hamden, CT, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2025,11,9]]},"reference":[{"key":"e_1_3_4_2_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1801550"},{"key":"e_1_3_4_3_2","doi-asserted-by":"publisher","DOI":"10.1093\/jac\/dkab091"},{"key":"e_1_3_4_4_2","doi-asserted-by":"publisher","DOI":"10.1038\/nrdp.2016.20"},{"key":"e_1_3_4_5_2","doi-asserted-by":"publisher","DOI":"10.1186\/s12879-023-08096-0"},{"key":"e_1_3_4_6_2","doi-asserted-by":"publisher","DOI":"10.1093\/ofid\/ofad171"},{"key":"e_1_3_4_7_2","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciy149"},{"key":"e_1_3_4_8_2","doi-asserted-by":"publisher","DOI":"10.1086\/525047"},{"key":"e_1_3_4_9_2","doi-asserted-by":"publisher","DOI":"10.1007\/s40121-023-00907-w"},{"key":"e_1_3_4_10_2","doi-asserted-by":"publisher","DOI":"10.1177\/0897190013499521"},{"key":"e_1_3_4_11_2","doi-asserted-by":"publisher","DOI":"10.1186\/s41687-020-0179-1"},{"key":"e_1_3_4_12_2","doi-asserted-by":"publisher","DOI":"10.1186\/s41687-022-00456-9"},{"key":"e_1_3_4_13_2","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciae437"},{"key":"e_1_3_4_14_2","doi-asserted-by":"publisher","DOI":"10.14309\/ajg.0000000000001278"},{"key":"e_1_3_4_15_2","unstructured":"US 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REBYOTA. Prescribing information https:\/\/www.fda.gov\/vaccines-blood-biologics\/vaccines\/rebyota (2022 accessed 16 May 2025)."},{"key":"e_1_3_4_16_2","unstructured":"REBYOTA\u00ae product monograph. North York ON: Ferring Pharmaceuticals Inc. 2025."},{"key":"e_1_3_4_17_2","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/civ938"},{"key":"e_1_3_4_18_2","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciy259"},{"key":"e_1_3_4_19_2","doi-asserted-by":"publisher","DOI":"10.1186\/s12879-022-07256-y"},{"key":"e_1_3_4_20_2","doi-asserted-by":"publisher","DOI":"10.1007\/s40121-022-00744-3"},{"key":"e_1_3_4_21_2","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-022-01797-x"},{"key":"e_1_3_4_22_2","doi-asserted-by":"publisher","DOI":"10.1177\/17562848251339697"},{"key":"e_1_3_4_23_2","article-title":"CONSORT 2025 statement: updated guideline for reporting randomised trials","volume":"389","author":"Hopewell S","year":"2025","unstructured":"Hopewell S, Chan AW, Collins GS, et al. 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