Fecal Microbiota Transplantation for the Management of Recurrent Clostridium Difficile Infections: A Systematic Review

Background: Fecal microbiota transplantation (FMT) is a promising therapeutic option for managing Clostridium difficile infections (CDI). CDI is a significant health concern, particularly in antibiotic-resistant cases impairing the quality of life among the patient population. This systematic review aims to pool current clinical trial evidence of FMT (RBX2660) success rates when used for recurrent CDI in the clinical trial setting.

Methods: In accordance with PRISMA Statement 2020 guidelines, the following databases were systematically searched: Embase, PubMed, and Scopus. There were no time or language restrictions. The following keywords were used in all the databases: fecal, microbiota, transplantation, recurrent, Clostridium difficile, infection, and antibiotic-resistant. Only clinical trials, controlled or single-arm, were included in this systematic review.

Results: A total of five clinical trials, of which four were phase II, and one was phase III, were included. Seven hundred ninety-five participants were pooled across all trials. Patients were included in the trials with 1-2 recurrent CDI. In most cases, they had undergone standard antibiotic therapy before enrolling. The treatment success rate in the RBX2660 intervention group was 69.5% (335/482) compared to 49.6% (123/248) in the placebo group. The intervention was safe and effective, with no grade III or higher adverse events reported in treating recurrent CDI.

Conclusion: RBX2660, recently approved as a therapy for recurrent CDI in the United States, is a significant milestone in expanding treatment options. This study reports the potential benefits of FMT and other microbiota-based therapies. While many challenges require addressing, including sample control and patient compliance, FMT is heading toward ongoing acceptance in the broad medical community.