Systematic review with meta-analysis: long-term outcomes of faecal microbiota transplantation for Clostridium difficile infection

Aliment Pharmacol Ther. 2016 Feb;43(4):445-57. doi: 10.1111/apt.13492. Epub 2015 Dec 14.


Background: Clostridium difficile infection is a major cause of nosocomial diarrhoea.

Aim: To evaluate long-term (≥90 days) efficacy and safety of faecal microbiota transplantation for C. difficile infection and explore the factors affecting the faecal microbiota transplantation outcomes.

Methods: MEDLINE, the Cochrane Library and EMBASE were searched and only observational studies that utilised faecal microbiota transplantation for C. difficile infection with long-term follow-up duration (≥90 days) were included. Primary cure rate, overall recurrence rate and early (<90 days) and late (≥90 days) recurrence rate were calculated.

Results: Eighteen observational studies with 611 patients were included. The primary cure rate was 91.2% (95% confidence interval, CI 86.7-94.8%). The overall recurrence rate was 5.5% (95% CI 2.2-10.3%). The early recurrence rate and late recurrence rate were 2.7% (95% CI 0.7-6.0%) and 1.7% (95% CI 0.4-4.2%) respectively. Most adverse events were expected, short-lived, self-limited and manageable. The association between faecal microbiota transplantation therapy and adverse events such as inflammatory bowel disease flare, infectious disease and autoimmune disease was a concern but remained insignificant. Old age (≥65 years) was identified as a risk factor for after faecal microbiota transplantation therapy. Upper gastrointestinal administration also results in less frequent primary cure.

Conclusions: Faecal microbiota transplantation seems to be a highly effective and robust therapy for recurrent C. difficile infection. However, more quality studies, such as randomised controlled trials and cohort studies with control groups, are needed to confirm its long-term efficacy and safety.

Publication types

  • Meta-Analysis
  • Research Support, Non-U.S. Gov't
  • Review
  • Systematic Review

MeSH terms

  • Age Factors
  • Clostridioides difficile*
  • Clostridium Infections / therapy*
  • Fecal Microbiota Transplantation / adverse effects
  • Fecal Microbiota Transplantation / methods*
  • Feces
  • Humans
  • Observational Studies as Topic
  • Recurrence
  • Risk Factors