Adverse events in fecal microbiota transplantation: a systematic review and meta-analysis.

Background: Fecal microbiota transplantation (FMT) is a highly efficacious procedure used most commonly for the treatment of recurrent Clostridioides difficile infection (CDI). Despite the high value of incorporating FMT into practice, there remain concerns about its safety. To the best of our knowledge, there has not been an updated meta-analysis reporting pooled rates of adverse events in FMT for CDI.

Methods: A search for studies of FMT in patients with CDI was performed with the rate of serious adverse events (SAEs) related to FMT evaluated as the primary outcome. Secondary outcomes included SAEs unrelated to FMT and minor adverse events associated with FMT. A pooled analysis was then performed.

Results: Initial search identified 378 reference articles. Data were extracted from the 61 of these studies that met the inclusion criteria, comprising 5099 patients. Pooled analysis showed that SAEs related to FMT developed in less than 1% of patients. The pooled rate of SAEs not related to FMT was higher at 2.9%. The pooled rate of minor adverse events also showed infrequent self-limited gastrointestinal and systemic discomfort.

Conclusions: This meta-analysis supports FMT as a safe option for treating recurrent CDI. Future randomized trials are needed to improve our current understanding of FMT safety and further examine the improvements in the quality of life of patients treated with FMT compared to standard therapy of antibiotics.