{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,13]],"date-time":"2026-06-13T04:15:13Z","timestamp":1781324113863,"version":"3.54.1"},"reference-count":26,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2025,4,22]],"date-time":"2025-04-22T00:00:00Z","timestamp":1745280000000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2025,4,22]],"date-time":"2025-04-22T00:00:00Z","timestamp":1745280000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"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":[[2025,7]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>\n                      Recurrent\n                      <jats:italic toggle=\"yes\">Clostridioides difficile<\/jats:italic>\n                      infection (rCDI) occurs in up to 35% of patients with CDI, and further recurrence is common. Fecal microbiota, live-jslm (RBL) is safe and effective for preventing rCDI in adults following antibiotic treatment for rCDI when administered rectally. There is clinical interest in alternative routes of administration.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives:<\/jats:title>\n                    <jats:p>CDI-SCOPE assessed the safety and clinical effectiveness of RBL when administered via colonoscopy to adults with rCDI.<\/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 one administration of RBL consisting of one 150-mL dose of RBL, delivered via colonoscopy to the right side of the colon. The primary endpoint assessed RBL-related treatment-emergent adverse events (TEAEs) within 8 weeks of RBL administration or until confirmed treatment failure. Secondary endpoints included treatment success (absence of CDI recurrence for 8\u2009weeks following RBL administration), physician experience administering RBL via colonoscopy, and physician perception of participant benefit.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>Of 54 participants screened, 41 were enrolled and received RBL via colonoscopy; 39 participants completed the 8-week visit. Five TEAEs in four participants (9.8%) were assessed as related to RBL, all of which were gastrointestinal and mild in severity. Overall, 18 participants (43.9%) experienced 33 TEAEs within 8\u2009weeks, most of which were of mild (25\/33; 75.8%) or moderate (5\/33; 15.2%) severity. No TEAEs led to intensive care unit admission or death. Overall, 39 participants (95.1%) experienced treatment success; 2 participants (4.9%) withdrew consent and had an indeterminate outcome. Among physicians, 90.2% of investigators indicated a \u201cpositive\u201d or \u201cvery positive\u201d experience administering RBL by colonoscopy. All physicians assessed participant benefit as \u201cmuch\u201d or \u201cvery much\u201d improved.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>This single-arm study suggests RBL administered via colonoscopy is practical, safe, and effective for preventing CDI recurrence following antibiotic treatment in adults.<\/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\/17562848251339697","type":"journal-article","created":{"date-parts":[[2025,4,23]],"date-time":"2025-04-23T02:23:03Z","timestamp":1745374983000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":8,"title":["Safety and effectiveness of fecal microbiota, live-jslm (REBYOTA\n                    <sup>\u00ae<\/sup>\n                    ) administered by colonoscopy for prevention of recurrent\n                    <i>Clostridioides difficile<\/i>\n                    infection: 8-week results from CDI-SCOPE, a single-arm, phase IIIb trial"],"prefix":"10.1177","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7619-8338","authenticated-orcid":false,"given":"Sahil","family":"Khanna","sequence":"first","affiliation":[{"name":"Mayo Clinic, 200 First Street 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":[[2025,4,22]]},"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":"10.1186\/s12879-023-08096-0"},{"key":"e_1_3_4_5_2","unstructured":"US Department of Health and Human Services. 2021 Annual report for the emerging infections program for Clostridioides difficile infection. Silver Spring MD: US Department of Health and Human Services https:\/\/archive.cdc.gov\/www_cdc_gov\/hai\/eip\/Annual-CDI-Report-2021.html (2023 accessed 31 March 2025)."},{"key":"e_1_3_4_6_2","unstructured":"Centers for Disease Control and Prevention. Antibiotics resistance threats in the United States 2019 https:\/\/www.cdc.gov\/drugresistance\/pdf\/threats-report\/2019-ar-threats-report-508.pdf (2019 accessed 5 October 2021)."},{"key":"e_1_3_4_7_2","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciae437"},{"key":"e_1_3_4_8_2","doi-asserted-by":"publisher","DOI":"10.14309\/ajg.0000000000001278"},{"key":"e_1_3_4_9_2","doi-asserted-by":"publisher","DOI":"10.1097\/MCG.0000000000001947"},{"key":"e_1_3_4_10_2","doi-asserted-by":"publisher","DOI":"10.1093\/ofid\/ofae127"},{"key":"e_1_3_4_11_2","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/cir632"},{"key":"e_1_3_4_12_2","doi-asserted-by":"publisher","DOI":"10.1093\/ofid\/ofad171"},{"key":"e_1_3_4_13_2","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciy149"},{"key":"e_1_3_4_14_2","doi-asserted-by":"publisher","DOI":"10.1086\/525047"},{"key":"e_1_3_4_15_2","doi-asserted-by":"publisher","DOI":"10.1152\/ajpgi.00282.2013"},{"key":"e_1_3_4_16_2","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2024.01.008"},{"key":"e_1_3_4_17_2","unstructured":"REBYOTA\u2122 (fecal microbiota live-jslm) suspension for rectal use (prescribing information). Roseville MN: Ferring Pharmaceuticals 2022."},{"key":"e_1_3_4_18_2","unstructured":"Ferring Pharmaceuticals. Ferring pharmaceuticals announces availability of REBYOTA\u2122 (fecal microbiota live-jslm)\u2014the first and only FDA-approved microbiome-based treatment for the prevention of recurrence of C. diff infection in adults. Parsippany NJ: Ferring Pharmaceuticals https:\/\/ferringusa.com\/?press=ferring-pharmaceuticals-announces-availability-of-rebyota-fecal-microbiota-live-jslm-the-first-and-only-fda-approved-microbiome-based-treatment-for-the-prevention-of-r (2023 accessed 31 March 2025)."},{"key":"e_1_3_4_19_2","doi-asserted-by":"publisher","DOI":"10.1007\/s40121-022-00744-3"},{"key":"e_1_3_4_20_2","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciy259"},{"key":"e_1_3_4_21_2","doi-asserted-by":"publisher","DOI":"10.1186\/s12879-022-07256-y"},{"key":"e_1_3_4_22_2","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/civ938"},{"key":"e_1_3_4_23_2","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-022-01797-x"},{"key":"e_1_3_4_24_2","doi-asserted-by":"publisher","DOI":"10.1177\/17562848231174277"},{"key":"e_1_3_4_25_2","doi-asserted-by":"publisher","DOI":"10.1177\/17562848241239547"},{"key":"e_1_3_4_26_2","doi-asserted-by":"publisher","DOI":"10.4103\/0976-500X.72352"},{"key":"e_1_3_4_27_2","doi-asserted-by":"publisher","DOI":"10.1038\/s41575-021-00441-5"}],"container-title":["Therapeutic Advances in Gastroenterology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/17562848251339697","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/17562848251339697","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/17562848251339697","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,1,6]],"date-time":"2026-01-06T08:15:58Z","timestamp":1767687358000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/17562848251339697"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,4,22]]},"references-count":26,"alternative-id":["10.1177\/17562848251339697"],"URL":"https:\/\/doi.org\/10.1177\/17562848251339697","relation":{},"ISSN":["1756-2848","1756-2848"],"issn-type":[{"value":"1756-2848","type":"print"},{"value":"1756-2848","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,4,22]]},"article-number":"17562848251339697"}}