Clinical question: Is fecal microbiota transplantation (FMT) by oral capsule noninferior to administration via colonoscopy in preventing recurrent Clostridium difficile infection (RCDI)?
Background: Approximately 20% of patients with an initial episode of C. difficile develop recurrent disease. FMT is the most effective treatment for RCDI. Currently, it is believed that there is a higher rate of success with FMT by colonoscopy, but this is based on studies lacking a control group. The cost of administering FMT by colonoscopy is more than double the cost via oral capsule, and efficacy between the two routes has not been studied in a randomized fashion. If oral capsule delivery is noninferior, then wait times, cost, and procedure risk would be reduced.
Study design: Randomized, unblinded, noninferiority trial.
Setting: Three academic medical centers in Alberta, Ca.
Synopsis: Patients with at least three documented episodes of C. difficile infection were randomized to receive FMT by either oral capsule or colonoscopy. Exclusion criteria included complicated C. difficile infections, cancer undergoing therapy, and conditions requiring antibiotics. The primary outcome was RCDI within 12 weeks after FMT. A total of 105 patients completed the trial, with 96.2% (51/53) of patients in the capsule group and 96.2% (50/52) of patients in the colonoscopy group remaining free of RCDI at the 12-week follow-up. This met the –15% noninferiority margin and suggests that oral capsule may be an effective route of delivery for FMT. Limitations of the study are exclusion of complicated RCDI patients, lack of blinding, and no placebo control (which would have been helpful since the prevention rates were so high and recurrent diarrhea was self-reported among participants, leading to a subjective outcome).
Bottom line: FMT by oral capsule may be noninferior to FMT by colonoscopy in preventing RCDI at 12 weeks.
Citation: Kao D et al. Effect of oral capsule- vs. colonoscopy-delivered fecal microbiota transplantation on recurrent Clostridium difficile infection: A randomized clinical trial..
Dr. Mehra is assistant professor of medicine, division of hospital medicine, University of Virginia.