Effect of Oral Capsule- vs Colonoscopy-Delivered Fecal Microbiota Transplantation on Recurrent Clostridium difficile Infection: A Randomized Clinical Trial.

ABSTRACT:

Importance

Fecal microbiota transplantation (FMT) is effective in preventing recurrent Clostridium difficile infection (RCDI). However, it is not known whether clinical efficacy differs by route of delivery.

Objective

To determine whether FMT by oral capsule is noninferior to colonoscopy delivery in efficacy.

Design, setting, and participants

Noninferiority, unblinded, randomized trial conducted in 3 academic centers in Alberta, Canada. A total of 116 adult patients with RCDI were enrolled between October 2014 and September 2016, with follow-up to December 2016. The noninferiority margin was 15%.

Interventions

Participants were randomly assigned to FMT by capsule or by colonoscopy at a 1:1 ratio.

Main outcomes and measures

The primary outcome was the pro

SUBMITTER: Kao D 

PROVIDER: S-EPMC5820695 | biostudies-literature | 2017 Nov

REPOSITORIES: biostudies-literature