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Singh T, Bedi P, Bumrah K, et al. Fecal Microbiota Transplantation and Medical Therapy for Clostridium difficile Infection: Meta-analysis of Randomized Controlled Trials. J Clin Gastroenterol. 2021 Sep 9. pii: 00004836-900000000-97372. doi: 10.1097/MCG.0000000000001610. (Systematic review)

GOALS: The aim was to assess the effectiveness of fecal microbiota transplantation (FMT) against medical therapy (MT).

BACKGROUND: FMT has shown good outcomes in the treatment of Clostridium difficile infection (CDI). We aimed to conduct a systematic review and meta-analysis to compare the effectiveness of FMT versus MT for CDI.

STUDY: We performed a comprehensive search to identify randomized controlled trials comparing FMT against MT in patients with CDI. Outcomes of interest were clinical cure as determined by the resolution of diarrhea and/or negative C. difficile testing. Primary CDI is defined as the first episode of CDI confirmed endoscopically or by laboratory analysis. Recurrent C. difficile infection (RCDI) is defined as laboratory or endoscopically confirmed episode of CDI after at least 1 course of approved antibiotic regimen.

RESULTS: A total of 7 studies with 238 patients were included in meta-analysis. Compared with MT, FMT did not have a statistically significant difference for clinical cure of combined primary and RCDI after first session [risk ratio (RR): 1.52, 95% confidence interval (CI): 0.90, 2.58; P=0.12; I2=77%] and multiple sessions of FMT (RR: 1.68; CI: 0.96, 2.94; P=0.07; I2=82%). On subgroup analysis, FMT has statistically higher rate of response than MT (RR: 2.41; CI: 1.20, 4.83; I2=78%) for RCDI. However, for primary CDI there is no statistically significant difference between FMT and MT (RR: 1.00; CI: 0.72, 1.39; I2=0%).

CONCLUSION: As per our analysis, FMT should not be utilized for every patient with CDI. It is more effective in RCDI, but the results were not significant in patients with primary CDI.

Discipline Area Score
Internal Medicine 7 / 7
Infectious Disease 6 / 7
Gastroenterology 5 / 7
Comments from MORE raters

Gastroenterology rater

I was never a friend of meta-analyses, so I am not enthusiastic about this study.

Gastroenterology rater

This is an interesting systematic review saying FMT only work in a subset of patients.

Gastroenterology rater

Despite some methodological drawbacks (exclusion of papers not published in English, and of those with less than 10 participants), this meta-analysis shows that fecal transplantation may not offer advantages over antibiotic treatment in patients with C. difficile colitis, since be it in its first episode or a recurring one. The risk of bias assessment of the source studies reveals the poor methodological quality of available research, which could affect the results found here. I believe that this question is not closed with this meta-analysis, but should invite the development of new randomized clinical trials with a rigorous design, and that define precisely which patient population could benefit the most from this therapeutic intervention.

Internal Medicine rater

This is a useful resource when answering questions on the usefulness of FMT in patients with recurrent CDI. The heterogeneity of data for primary CDI dampens the strength of the conclusion on primary CDI.
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