Related Experiment Video
Updated: Sep 25, 2025
Therapeutic Evaluation of Fecal Microbiota Transplantation in an Interleukin 10-Deficient Mouse Model
Published on: April 6, 2022
Adverse events in fecal microbiota transplantation: a systematic review and meta-analysis
Eliot A Rapoport1, Muhammad Baig1, Srinivas R Puli1
1Department of Gastroenterology and Hepatology, University of Illinois College of Medicine at Peoria, Peoria, IL, USA (Eliot A. Rapoport, Muhammad Baig, Srinivas R. Puli).
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.
Insights
Fecal microbiota transplantation (FMT) is a safe and effective treatment for recurrent Clostridioides difficile infection (CDI). This meta-analysis found serious adverse events related to FMT occurred in less than 1% of patients, supporting its use.
Area of Science:
- Gastroenterology
- Infectious Diseases
- Microbiome Research
Background:
- Fecal microbiota transplantation (FMT) is a highly effective treatment for recurrent Clostridioides difficile infection (CDI).
- Despite its efficacy, concerns regarding the safety of FMT persist.
- An updated meta-analysis on FMT safety for CDI was lacking.
Purpose of the Study:
- To conduct a meta-analysis to determine the pooled rates of adverse events associated with FMT in patients with CDI.
- To evaluate the safety profile of FMT for treating recurrent CDI.
Main Methods:
- A comprehensive literature search was conducted to identify studies on FMT for CDI.
- Serious adverse events (SAEs) related to FMT were the primary outcome.
- Secondary outcomes included SAEs unrelated to FMT and minor adverse events.
Main Results:
- Data from 61 studies involving 5099 patients were analyzed.
- SAEs directly related to FMT occurred in less than 1% of patients.
- SAEs not related to FMT occurred in 2.9% of patients, with infrequent, self-limited minor adverse events.
Conclusions:
- FMT is a safe therapeutic option for recurrent CDI.
- Further randomized controlled trials are recommended to enhance understanding of FMT safety and its impact on patient quality of life compared to antibiotic therapy.
