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News
FDA-approved fecal microbiota transplantation (FMT) products have largely replaced conventional FMT for recurrent C. diff prevention — but a critical gap remains for the sickest patients. Gastroenterologist Colleen Kelly, MD, breaks down where FMT research stands today, including a new open-label study exploring its potential in Crohn's disease. The field is moving fast, but key questions around fulminant CDI and IBD remain unanswered.
Two FDA-approved FMT products have largely taken over from conventional fecal microbiota transplantation for preventing recurrent Clostridioides difficile infection (CDI) — but they come with a notable blind spot. Neither product is approved for acute, severe, or fulminant CDI, leaving critically ill and ICU patients in a therapeutic gray zone. Dr. Colleen Kelly of Brigham and Women's Hospital is actively working with the FDA to close that gap, while also exploring open-label data collection through the FMT National Patient Registry.
Beyond C. diff, Kelly and colleagues are running a multicenter open-label study examining whether FMT can meaningfully impact Crohn's disease — the next logical frontier given FMT's success in CDI and the shared role of gut dysbiosis. Enrollment has been slow but steady, with results still years away.
Key Takeaways:
Why it matters: FMT has already transformed recurrent CDI management, but its potential — and its gaps — are still being mapped. As research expands into IBD and other dysbiosis-related conditions, clinicians need to understand both what's approved and what remains experimental.
