Safety and efficacy of fecal microbiota transplantation versus antibiotics for treating clostridioides difficile infection: systematic review and meta-analysis.
Level 1 - systematic review of randomized trials
Systematic review and meta-analysis of clinical trials
PubMed 41081988 · doi:10.1007/s10096-025-05278-3
What was done
A systematic review and meta-analysis of clinical trials identified via PubMed, Embase, and the Cochrane Library comparing fecal microbiota transplantation (FMT) with standard antibiotic therapy (vancomycin or fidaxomicin) for recurrent Clostridioides difficile infection (CDI). Study quality was evaluated using Cochrane RoB 2 and ROBINS-I tools. Primary outcomes included infection resolution, recurrence, all-cause mortality, and adverse events, analyzed using a random-effects model to generate risk ratios (RR) with 95% confidence intervals (CI).
What was found
Across 9 clinical trials involving 759 patients: - FMT significantly improved CDI resolution compared to antibiotics: RR 1.51 (95% CI: 1.29 to 1.78). - Recurrence was significantly lower following FMT: RR 0.38 (95% CI: 0.29 to 0.50). - Mortality did not differ significantly between groups (RR = 0.95; CI not reported in abstract). - Adverse event rates were comparable between groups, with no serious adverse events directly attributed to FMT. - Subgroup analysis showed that lower gastrointestinal route administration was significantly more effective (p = 0.02) for both resolution and recurrence.
Why it matters
This review reinforces that FMT is superior to standard antibiotic regimens for resolving recurrent CDI and preventing subsequent relapses, with comparable safety.
Limits
The total sample size across 9 included trials is relatively small (759 patients). The abstract does not report confidence intervals for mortality, exact numbers for adverse events, or statistical heterogeneity (I-squared values). Use of the ROBINS-I tool suggests non-randomized or quasi-randomized comparative studies may have been included. Protocol variations such as FMT delivery route, donor preparation, and specific antibiotic comparators were not fully detailed in the abstract.
Cited by
- supports Fecal microbiota transplants are used successfully to treat and prevent death from Clostridium difficile (C. diff) infections.