Retrospective subgroup analysis of fecal microbiota, live-jslm (REBYOTA) administered by colonoscopy under enforcement discretion for the prevention of recurrent infection.

Background: Fecal microbiota, live-jslm (RBL; REBYOTA), is the first Food and Drug Administration (FDA)-approved, single-dose, rectally administered, microbiota-based live biotherapeutic product for preventing infection (CDI) recurrence. Alternative routes of administration are of clinical interest.

Objectives: Evaluate the safety and efficacy of RBL administration colonoscopy.

Design: Retrospective analysis of electronic medical records of participants administered RBL colonoscopy under FDA enforcement discretion.

Methods: The number of participants with treatment and/or procedure-emergent adverse events (TEAEs) was evaluated. Treatment success and sustained clinical response, defined as the absence of CDI recurrence within 8 weeks and 6 months, respectively, were evaluated.

Results: TEAEs were experienced by 75% (6/8) of participants; most were mild to moderate in severity, and none due to RBL or its administration. Most participants had treatment success (80%; 8/10); 75% (6/8) had sustained clinical response.

Conclusion: Real-world safety and efficacy of RBL administered colonoscopy were consistent with clinical trials of rectally administered RBL.