Microbiota-Based Therapies for Recurrent Clostridium difficile Infection: A Systematic Review of Their Efficacy and Safety
Abstract
Recurrent Clostridium difficile infection (RCDI) remains a significant clinical challenge, with high recurrence rates following standard antibiotic therapy. Emerging evidence supports the role of fecal microbiota transplant (FMT) and standardized microbiome therapeutics (e.g., SER-109, RBX2660) in gut microbiota restoration and recurrence prevention. This systematic review evaluates the effectiveness and safety of these approaches in comparison to traditional therapies. Following the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) 2020 guidelines, we searched the databases PubMed/MEDLINE, ScienceDirect, Cochrane Library, Europe PubMed Central (Europe PMC), ClinicalTrials.gov, Google Scholar, and Elicit AI for studies published between January 2015 and May 2025. Eligible studies included randomized controlled trials (RCTs), observational studies, and case series assessing FMT in adults with rCDI. The risk of bias was assessed using the Cochrane Risk of Bias 2.0 tool (RoB 2) for RCTs and the Newcastle-Ottawa Scale (NOS) for cohort studies. Seven studies (six RCTs, one cohort; N=1,030 patients) were included. FMT demonstrated superior efficacy compared to antibiotics/placebo, with clinical cure rates ranging from 70% to 91% (versus 23% to 62%). Donor FMT outperformed autologous FMT (90.9% vs. 62.5%, p = 0.042) and standard therapies (71% resolution vs. 33% fidaxomicin/19% vancomycin, p < 0.01). Microbiota-based therapies (SER-109, RBX2660)…
How strong is the evidence?
Evidence Hub reads this as a systematic review, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid. Reported size: 1,030 participants or records.
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