Therap Adv Gastroentero

Fecal microbiota via colonoscopy safe and effective for prevention of recurrent CDI

May 9, 2025

Study details: The CDI-SCOPE trial (NCT05831189) was a single-arm, phase IIIb study conducted at 12 sites in the U.S. It evaluated the safety and effectiveness of fecal microbiota, live-jslm (Rebyota), administered via colonoscopy to adults with recurrent Clostridioides difficile infection (rCDI). Participants received a single 150-mL dose of Rebyota delivered to the right side of the colon.

Results: Of the 41 participants who received Rebyota, 39 completed the 8-week follow-up. Five treatment-emergent adverse events (TEAEs) in four participants (9.8%) were deemed to be related to RBL, all of which were GI-related and mild in severity. A total of 18 participants (43.9%) experienced 33 TEAEs within 8 weeks, most of which were of mild (75.8%) or moderate (15.2%) in severity. The treatment success rate was 95.1%, with no serious adverse events leading to ICU admission or death.

Clinical impact: The results suggest that Rebyota administered via colonoscopy is a practical, safe, and effective method for preventing CDI recurrence following antibiotic treatment in adults. The high treatment success rate and favorable safety profile support its use in clinical practice for managing rCDI.

Source:

Khanna S, et al. (2025, April 22). Therap Adv Gastroenterol. Safety and effectiveness of fecal microbiota, live-jslm (REBYOTA^®) administered by colonoscopy for prevention of recurrent Clostridioides difficile infection: 8-week results from CDI-SCOPE, a single-arm, phase IIIb trial. https://pubmed.ncbi.nlm.nih.gov/40321366/