Fecal microbiota transplantation for the treatment of recurrent Clostridioides difficile (Clostridium difficile).
Level 1 - systematic review of randomized trials
Systematic review and meta-analysis of randomized controlled trials
PubMed 37096495 · doi:10.1002/14651858.CD013871.pub2
What was done
This Cochrane systematic review evaluated randomized controlled trials assessing the benefits and harms of donor-derived fecal microbiota transplantation (FMT) versus control therapies (placebo, autologous FMT, no intervention, or anti-C. difficile antibiotics) in adults with recurrent Clostridioides difficile infection (rCDI). Literature searches were conducted through March 31, 2022. Primary outcomes were the proportion of participants with resolution of rCDI and serious adverse events. Secondary outcomes included treatment failure, all-cause mortality, adverse events, quality of life, and colectomy. Risk of bias was assessed with RoB 2, and evidence certainty was graded using GRADE.
What was found
Six randomized trials comprising 320 adult participants were included: - Resolution of rCDI: FMT led to a large increase in resolution compared to control regimens (RR 1.92, 95% CI 1.36 to 2.71; P = 0.02; I² = 63%; 6 studies, 320 participants; NNTB = 3; moderate-certainty evidence). - Serious adverse events: FMT probably resulted in a slight reduction, though confidence intervals were wide (RR 0.73, 95% CI 0.38 to 1.41; P = 0.24; I² = 26%; 6 studies, 320 participants; NNTB = 12; moderate-certainty evidence). - All-cause mortality: FMT was associated with an imprecise reduction (RR 0.57, 95% CI 0.22 to 1.45; P = 0.48; I² = 0%; 6 studies, 320 participants; NNTB = 20; low-certainty evidence). - Colectomy: No included study reported colectomy rates.
Why it matters
FMT provides a clear and substantial therapeutic benefit over standard antibiotic regimens for resolving recurrent C. difficile infection in immunocompetent adults, requiring only three patients to be treated to achieve one additional resolution.
Limits
The total sample size is small (320 participants across six trials). Severe immunocompromise was an exclusion criterion in five studies (only 10 immunocompromised patients were included across the entire review), precluding conclusions in this subpopulation. Delivery routes varied across trials (nasoduodenal, nasojejunal, enema, colonoscopy). Event counts for serious adverse events and mortality were small, limiting safety precision.
Cited by
- supports Fecal microbiota transplants are used successfully to treat and prevent death from Clostridium difficile (C. diff) infections.