Abstract

INTRODUCTION: Fecal microbiota transplantation (FMT) has emerged as a safe and effective treatment for recurrent Clostridium difficile infection (rCDI). FMT can be delivered via the upper gastrointestinal tract (UGIT) or lower GIT. Recently, oral capsule delivery has been demonstrated to be non-inferior to other routes. However, oral administration lends the capsule susceptible to pH changes and intestinal microbiota exposures prior to reaching the colon. There is a lack of consistency between studies evaluating FMT capsules with respect to multiple factors. This systematic review aimed at identifying factors within these studies that could impact remission rates such as type of capsule preparation, prior acid suppression therapy and colon preparation before treatment. METHODS: An electronic search was conducted using PubMed, Scopus, EMBASE and Cochrane Central Register of Controlled Trials. The search strategy was not limited by language. Search terms for both the free text and medical subject heading (MeSH) included “fecal microbiota transplantation” and “capsule.” Eligibility criteria included clinical trials using FMT for rCDI and delivery by capsule. Exclusion criteria included lack of capsule manufacturing description or endpoints related to CDI resolution. RESULTS: The initial search strategy yielded 93 publications. 30 duplicates were removed. 37 were excluded after screening titles and abstracts. 26 full papers were reviewed and of these, 11 met our eligibility criteria (See Table 1). A total of 425 patients were evaluated who underwent FMT via capsule delivery. Remission rates among studies ranged from 68% to 100%. Timeframe defining remission varied among studies, though 10/11 defined remission as resolution of diarrhea at least 8 weeks after FMT. The pooled remission rate was 86.6% in those receiving colon prep prior to FMT, 83.9% in those who received double-encapsulated formulations and 75.4% in those using PPIs prior to FMT (See Table 2). Heterogeneity among reported study protocols prohibited statistical analysis of these factors. CONCLUSION: Oral administration of FMT capsules greatly simplifies this treatment option for patients with rCDI. This systematic review highlights inconsistencies in reporting of the methodology used in FMT capsule studies, which can be contributing to variable remission rates. Future randomized trials are needed to compare the various factors outlined above.

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