The following is a summary of “A randomized controlled trial of efficacy and safety of Fecal Microbiota Transplant for preventing recurrent Clostridioides difficile infection,” published in the  September 2024  issue of Infectious Disease by Drekonja et al.

Clostridioides difficile infection (CDI) is the leading cause of healthcare-associated conditions in US hospitals, with 15-30% of patients with recurrence.

Researchers conducted a retrospective study to evaluate the efficacy of capsule-delivered fecal microbiota transplantation (FMT) vs placebo in decreasing recurrent diarrhea and CDI recurrence and FMT safety assessment.

They examined Veterans Health Administration (VHA) patients with recurrent CDI who responded to antibiotic treatment (2018-2022). Patients were randomized 1:1 to oral FMT or placebo capsules, stratified by number of prior CDI recurrences (1 or ≥2). The primary endpoint was clinical recurrence by day 56, defined as >3 unformed stools daily for ≥2 days with or without laboratory confirmation of C. difficile or death within 56 days.

The results showed that the study was halted for futility after meeting pre-specified criteria. Out of 153 participants (76 FMT, 77 placebo) with a mean age of 66.5 years, 25 participants (32.9%) in the FMT group and 23 (29.9%) in the placebo group experienced the primary endpoint of diarrhea, possible or definite CDI recurrence, or death within 56 days of capsule administration (absolute difference 3.0%; 95% CI [-11.7%, 17.7%]). Stratification by recurrence number showed no differences and clinical dissimilarities in adverse events.

They concluded that FMT therapy did not reduce CDI recurrence or death at 56 days compared to placebo, and there were no meaningful differences in adverse events between the treatment groups.

Source: academic.oup.com/cid/advance-article/doi/10.1093/cid/ciae467/7756590