Effect of Fecal Microbiota Transplantation on Recurrence in Multiply Recurrent Clostridium difficile Infection: A Randomized Trial
Annals of internal medicine, 2016•acpjournals.org
Background: To date, evidence for the efficacy of fecal microbiota transplantation (FMT) in
recurrent Clostridium difficile infection (CDI) has been limited to case series and open-label
clinical trials. Objective: To determine the efficacy and safety of FMT for treatment of
recurrent CDI. Design: Randomized, controlled, double-blind clinical trial.(ClinicalTrials. gov:
NCT01703494) Setting: Two academic medical centers. Patients: 46 patients who had 3 or
more recurrences of CDI and received a full course of vancomycin for their most recent acute …
recurrent Clostridium difficile infection (CDI) has been limited to case series and open-label
clinical trials. Objective: To determine the efficacy and safety of FMT for treatment of
recurrent CDI. Design: Randomized, controlled, double-blind clinical trial.(ClinicalTrials. gov:
NCT01703494) Setting: Two academic medical centers. Patients: 46 patients who had 3 or
more recurrences of CDI and received a full course of vancomycin for their most recent acute …
Background
To date, evidence for the efficacy of fecal microbiota transplantation (FMT) in recurrent Clostridium difficile infection (CDI) has been limited to case series and open-label clinical trials.
Objective
To determine the efficacy and safety of FMT for treatment of recurrent CDI.
Design
Randomized, controlled, double-blind clinical trial. (ClinicalTrials.gov: NCT01703494)
Setting
Two academic medical centers.
Patients
46 patients who had 3 or more recurrences of CDI and received a full course of vancomycin for their most recent acute episode.
Intervention
Fecal microbiota transplantation with donor stool (heterologous) or patient's own stool (autologous) administered by colonoscopy.
Measurements
The primary end point was resolution of diarrhea without the need for further anti-CDI therapy during the 8-week follow-up. Safety data were compared between treatment groups via review of adverse events (AEs), serious AEs (SAEs), and new medical conditions for 6 months after FMT. Fecal microbiota analyses were performed on patients' stool before and after FMT and also on donors' stool.
Results
In the intention-to-treat analysis, 20 of 22 patients (90.9%) in the donor FMT group achieved clinical cure compared with 15 of 24 (62.5%) in the autologous FMT group ( P = 0.042). Resolution after autologous FMT differed by site (9 of 10 vs. 6 of 14 [P = 0.033]). All 9 patients who developed recurrent CDI after autologous FMT were free of further CDI after subsequent donor FMT. There were no SAEs related to FMT. Donor FMT restored gut bacterial community diversity and composition to resemble that of healthy donors.
Limitation
The study included only patients who had 3 or more recurrences and excluded those who were immunocompromised and aged 75 years or older.
Conclusion
Donor stool administered via colonoscopy seemed safe and was more efficacious than autologous FMT in preventing further CDI episodes.
Primary Funding Source
National Institute of Diabetes and Digestive and Kidney Diseases.
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