Safety and effectiveness of fecal microbiota, live-jslm (REBYOTA) administered by colonoscopy for prevention of recurrent infection: 8-week results from CDI-SCOPE, a single-arm, phase IIIb trial
Background: Recurrent Clostridioides difficile 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...
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| Format: | Article |
| Language: | English |
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SAGE Publishing
2025-05-01
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| Series: | Therapeutic Advances in Gastroenterology |
| Online Access: | https://doi.org/10.1177/17562848251339697 |
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| author | Sahil Khanna David Yoho Daniel Van Handel Brian J. Clark Tahany Awad Beth Guthmueller Daniel Armandi Whitfield Knapple Nasia Safdar Brian Baggott Karen Simon Paul Feuerstadt |
| author_facet | Sahil Khanna David Yoho Daniel Van Handel Brian J. Clark Tahany Awad Beth Guthmueller Daniel Armandi Whitfield Knapple Nasia Safdar Brian Baggott Karen Simon Paul Feuerstadt |
| author_sort | Sahil Khanna |
| collection | DOAJ |
| description | Background: Recurrent Clostridioides difficile 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. Objectives: CDI-SCOPE assessed the safety and clinical effectiveness of RBL when administered via colonoscopy to adults with rCDI. Design: Single-arm, exploratory phase IIIb trial conducted at 12 sites in the United States. Methods: 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 weeks following RBL administration), physician experience administering RBL via colonoscopy, and physician perception of participant benefit. Results: 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 weeks, 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 “positive” or “very positive” experience administering RBL by colonoscopy. All physicians assessed participant benefit as “much” or “very much” improved. Conclusion: This single-arm study suggests RBL administered via colonoscopy is practical, safe, and effective for preventing CDI recurrence following antibiotic treatment in adults. Trial registration: ClinicalTrials.gov: NCT05831189. |
| format | Article |
| id | doaj-art-c8cb06a0a8a64d6fa8651f4d419b9023 |
| institution | Kabale University |
| issn | 1756-2848 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | SAGE Publishing |
| record_format | Article |
| series | Therapeutic Advances in Gastroenterology |
| spelling | doaj-art-c8cb06a0a8a64d6fa8651f4d419b90232025-08-20T03:48:31ZengSAGE PublishingTherapeutic Advances in Gastroenterology1756-28482025-05-011810.1177/17562848251339697Safety and effectiveness of fecal microbiota, live-jslm (REBYOTA) administered by colonoscopy for prevention of recurrent infection: 8-week results from CDI-SCOPE, a single-arm, phase IIIb trialSahil KhannaDavid YohoDaniel Van HandelBrian J. ClarkTahany AwadBeth GuthmuellerDaniel ArmandiWhitfield KnappleNasia SafdarBrian BaggottKaren SimonPaul FeuerstadtBackground: Recurrent Clostridioides difficile 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. Objectives: CDI-SCOPE assessed the safety and clinical effectiveness of RBL when administered via colonoscopy to adults with rCDI. Design: Single-arm, exploratory phase IIIb trial conducted at 12 sites in the United States. Methods: 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 weeks following RBL administration), physician experience administering RBL via colonoscopy, and physician perception of participant benefit. Results: 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 weeks, 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 “positive” or “very positive” experience administering RBL by colonoscopy. All physicians assessed participant benefit as “much” or “very much” improved. Conclusion: This single-arm study suggests RBL administered via colonoscopy is practical, safe, and effective for preventing CDI recurrence following antibiotic treatment in adults. Trial registration: ClinicalTrials.gov: NCT05831189.https://doi.org/10.1177/17562848251339697 |
| spellingShingle | Sahil Khanna David Yoho Daniel Van Handel Brian J. Clark Tahany Awad Beth Guthmueller Daniel Armandi Whitfield Knapple Nasia Safdar Brian Baggott Karen Simon Paul Feuerstadt Safety and effectiveness of fecal microbiota, live-jslm (REBYOTA) administered by colonoscopy for prevention of recurrent infection: 8-week results from CDI-SCOPE, a single-arm, phase IIIb trial Therapeutic Advances in Gastroenterology |
| title | Safety and effectiveness of fecal microbiota, live-jslm (REBYOTA) administered by colonoscopy for prevention of recurrent infection: 8-week results from CDI-SCOPE, a single-arm, phase IIIb trial |
| title_full | Safety and effectiveness of fecal microbiota, live-jslm (REBYOTA) administered by colonoscopy for prevention of recurrent infection: 8-week results from CDI-SCOPE, a single-arm, phase IIIb trial |
| title_fullStr | Safety and effectiveness of fecal microbiota, live-jslm (REBYOTA) administered by colonoscopy for prevention of recurrent infection: 8-week results from CDI-SCOPE, a single-arm, phase IIIb trial |
| title_full_unstemmed | Safety and effectiveness of fecal microbiota, live-jslm (REBYOTA) administered by colonoscopy for prevention of recurrent infection: 8-week results from CDI-SCOPE, a single-arm, phase IIIb trial |
| title_short | Safety and effectiveness of fecal microbiota, live-jslm (REBYOTA) administered by colonoscopy for prevention of recurrent infection: 8-week results from CDI-SCOPE, a single-arm, phase IIIb trial |
| title_sort | safety and effectiveness of fecal microbiota live jslm rebyota administered by colonoscopy for prevention of recurrent infection 8 week results from cdi scope a single arm phase iiib trial |
| url | https://doi.org/10.1177/17562848251339697 |
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