Food and Drug Administration-Approved Fecal Microbiota-Based Therapies for Recurrent Clostridioides difficile Infection.

Authors

Parul Berry, Jessica R Allegretti, Sahil Khanna

Published in

Gastroenterology clinics of North America. Volume 55. Issue 3. Pages 503-516. Epub Jun 17, 2026.

Abstract

Recurrent Clostridioides difficile infection remains common despite optimized antibiotic therapy. Two Food and Drug Administration-approved donor-derived fecal microbiota-based products, fecal microbiota, live-jslm (Rebyota / RBL) and fecal microbiota spores, live-brpk (Vowst / VOS) reduce recurrence when administered after completion of standard antibiotics. This review summarizes the clinical development programs supporting these products, including pivotal randomized trials, open-label extensions, durability data, safety outcomes, and emerging real-world evidence. We also discuss patient selection, timing after antibiotics, diagnostic considerations, and practical implementation. These therapies represent standardized, evidence-based approaches to restoring colonization resistance and preventing recurrent infection in appropriately selected adults.

PMID:
42538093
Bibliographic data and abstract were imported from PubMed on 01 Aug 2026.

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