Clinical question: Is fecal microbiota transplantation (FMT) an efficacious and safe treatment approach for patients with recurrent Clostridium difficile infection (CDI)?
Background: FMT restores the normal composition of gut microbiota and is recommended when antibiotics fail to clear CDI. To date, only case series and open-labeled clinical trials support the use of FMT.
Study design: Randomized, controlled, double-blinded clinical trial.
Setting: Academic medical centers.
Synopsis: This study included 46 patients with three or more recurrences of CDI who received a course of vancomycin for their most recent acute episode. FMTs with donor stool or patient’s stool (autologous) were administered by colonoscopy.
The primary endpoint was resolution of diarrhea without anti-CDI therapy after 8 weeks of follow-up. In the donor FMT group, 90.9% achieved clinical cure, compared with 62.5% in the autologous group. Patients who developed recurrent CDI were free of further disease after subsequent donor FMT.
The study included only patients who experienced three or more recurrences but excluded immunocompromised and older patients (older than 75 years of age).
Bottom line: Donor stool administered via colonoscopy was more effective than autologous FMT in preventing further CDI episodes.
Citation: Kelly CR, Khoruts A, Staley C, et al. Effect of fecal microbiota transplantation on recurrence in multiply recurrent Clostridium difficile infection: a randomized trial. Ann Intern Med. 2016;165(9):609-616.
Dr. Fernandez de la Vara is an instructor at the University of Miami Miller School of Medicine and chief medical resident at the University of Miami Hospital.