Methods and Reporting Studies Assessing Fecal Microbiota Transplantation: A Systematic Review

Ann Intern Med. 2017 Jul 4;167(1):34-39. doi: 10.7326/M16-2810. Epub 2017 May 23.


Background: Fecal microbiota transplantation (FMT) could be a novel treatment option for several chronic diseases associated with altered gut microbiota.

Purpose: To examine the conduct and reporting of studies assessing FMT.

Data sources: Cochrane Central Register of Controlled Trials, PubMed, EMBASE, and Web of Science from inception to 31 January 2017.

Study selection: Two reviewers independently examined titles and abstracts to identify all English-language reports of human clinical studies assessing the safety or efficacy of FMT.

Data extraction: Three reviewers independently assessed study types and characteristics and the reporting of important methodological components of the FMT intervention.

Data synthesis: Most (84%) of the 85 published reports found addressed the use of FMTs for Clostridium difficile infection or inflammatory bowel disease, and most (87%) were non-randomized controlled trials. Important methodological components that were not reported in published studies included the following: eligibility criteria for donors (47%), materials used for collecting stools and the period of collection (96%), methods used for conservation of stools (76%), the amount and type of stools used (for example, fresh or frozen), and duration of stool conservation (67%). Many (58%) did not report an analysis of microbiota composition.

Limitations: Lack of universal consensus regarding the most important methodological components of FMT and inability to assess the actual conduct of studies and whether the publication process affected the completeness of reporting.

Conclusion: Key components of FMT interventions, which are necessary to replicate and understand study findings about efficacy and safety, are poorly reported.

Primary funding source: No specific funding.

Publication types

  • Review
  • Systematic Review

MeSH terms

  • Clostridioides difficile
  • Clostridium Infections / therapy
  • Fecal Microbiota Transplantation*
  • Humans
  • Inflammatory Bowel Diseases / therapy
  • Research Design*