Orally administered fecal microbiota transplantation (FMT) for treatment of recurrent Clostridium difficile infection (RCDI) was not inferior to colonoscopy delivery according to results published in the Journal of the American Medical Association.
C difficile infection is the main cause of healthcare-associated infectious diarrhea and up to 30% of patients suffer recurrence. FMT is the most effective treatment for RCDI and is delivered via colonoscopy or the upper gastrointestinal route. Clinical efficacy was tested in a randomized trial (ClinicalTrials.gov identifier: NCT02254811) using the same amount of donor stool administered by oral capsule or colonoscopy.
Participants age 18 to 90 with at least 3 documented cases of CDI were randomly assigned to the capsule (n=57) or colonoscopy (n=59) group. The primary study outcome of no evidence of RCDI 12 weeks post-FMT was achieved in 96.2% of participants in each group (difference, 0%; 1-sided 95% CI, −6.1% to infinity; P <.001) meeting noninferiority criteria.
Minor adverse events occurred in 5.6% of the capsule group and 12.5% of the colonoscopy group. No infectious complications from FMT or colonic perforation occurred.
The trial did not include a placebo group or and was not blinded. However, assuming similar placebo effects in both groups still allows comparisons to be made, and blinding would have required capsule groups to undergo an expensive and invasive procedure. In addition, blinding would not have allowed for assessment of patients’ preference as a significant percentage of the capsule group participants rated the experience as “not unpleasant at all.”
Advantages to capsule delivery include patient preference, potential cost reduction, and wait time. Although complete economic evaluations are still needed, the investigators conclude that treatment with oral capsules may be an effective option in RCDI.
Kao D, Roach B, Silva M, et al. Effect of oral capsule– vs colonoscopy-delivered fecal microbiota transplantation on recurrent Clostridium difficile infection: a randomized clinical trial. JAMA. 2017;318:1985-1993.