FMT via colonoscopy bests placebo for preventing recurrent C. difficile

Issue: December 10, 2015

HONOLULU — Researchers have performed a multicenter, randomized, placebo-controlled, double-blind trial of fecal microbiota transplant via colonoscopy, which demonstrated superiority vs. placebo for prevention of further episodes in patients with recurrent Clostridium difficile infection, according to a presenter at ACG 2015.

“To date, numerous case series and two open-label clinical trials have shown FMT to be efficacious for recurrent or refractory C. difficile infection,” Colleen R. Kelly, MD, FACG, assistant professor of medicine at the Alpert Medical School of Brown University in Providence, Rhode Island, said during her presentation. “It was our aim to determine the efficacy and safety of FMT in recurrent CDI.”

Colleen R. Kelly

Kelly and colleagues enrolled 46 patients from two centers who had received at least a 10-day course of vancomycin for their most recent acute CDI episode, and randomly assigned them to receive FMT with donor stool or the subject’s own stool (placebo) via colonoscopy. Patients were then followed for 8 weeks to assess the primary endpoint of clinical cure, and 6-month safety data was also reviewed.

The intention-to-treat analysis showed 91% of patients who received FMT achieved resolution of diarrhea and no further requirements for CDI treatment compared with 63% of the placebo group (P = .024). Clinical failures occurred at a mean of 10 (range, 1-62) days after the procedure. Eleven patients developed recurrent CDI after FMT, 10 of whom achieved clinical cure after subsequently receiving an open-label FMT with donor stool (the other was lost to follow-up). No serious adverse events related to FMT occurred, and adverse events were comparable between treatment and placebo groups. No patients had late CDI recurrence between 8 and 24 weeks of follow-up.

“In conclusion, in patients with recurrent CDI, FMT administered via colonoscopy was significantly more effective than placebo for prevention of further CDI episodes,” Kelly said.

“Differences in efficacy by site were observed and may be explained by different characteristics of enrolled subjects at each site. And finally, there were no serious adverse events directly related to FMT and the rate of other adverse events did not differ significantly from placebo-treated patients.” – by Adam Leitenberger

Reference:

Kelly CR, et al. Abstract 44. Presented at: ACG 2015; Oct. 19-21, 2015; Honolulu, HI.

Disclosures: Kelly reports financial relationships with Seres Health and Assembly Biosciences. Please see the abstract for a list of all other researchers' relevant financial disclosures.