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Updated: Jul 18, 2026

Fecal Microbiota Transplantation via Colonoscopy for Recurrent C. difficile Infection
Published on: December 8, 2014
Methods and Reporting Studies Assessing Fecal Microbiota Transplantation: A Systematic Review
Aïda Bafeta1, Amelie Yavchitz1, Carolina Riveros1
1From INSERM U1153, Assistance Publique-Hôpitaux de Paris, Centre d'Epidémiologie Clinique, Hôpital Hôtel-Dieu, Université Paris Descartes-Sorbonne Paris Cité, French Cochrane Centre, and Hôpital Cochin, Paris, France, and Mailman School of Public Health, Columbia University, New York, New York.
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.
Insights
Fecal microbiota transplantation (FMT) studies often lack crucial methodological details for replication and understanding efficacy. Key components of FMT interventions are poorly reported in published research.
Area of Science:
- Gastroenterology and Hepatology
- Microbiology
- Clinical Research Methodology
Background:
- Fecal microbiota transplantation (FMT) is a potential novel therapy for chronic diseases linked to gut dysbiosis.
- Research is exploring FMT's role beyond its established use in Clostridium difficile infection.
Purpose of the Study:
- To critically evaluate the methodology and reporting standards of clinical studies investigating fecal microbiota transplantation (FMT).
- To identify gaps in the reporting of essential FMT intervention components.
Main Methods:
- Systematic review of English-language human clinical studies on FMT safety or efficacy.
- Searches conducted across major databases (PubMed, EMBASE, Web of Science, Cochrane).
- Independent assessment of study characteristics and reporting of methodological elements by multiple reviewers.
Main Results:
- Most studies (84%) focused on Clostridium difficile infection or inflammatory bowel disease, predominantly using non-randomized designs (87%).
- Significant reporting deficiencies were noted in donor eligibility (47%), stool collection materials and timing (96%), stool conservation methods (76%), stool type/amount (not specified), and conservation duration (67%).
- Microbiota composition analysis was absent in 58% of studies.
Conclusions:
- A lack of consensus on critical FMT methodological components hinders study assessment and reproducibility.
- Poor reporting of key FMT intervention details compromises the ability to understand and replicate study findings on efficacy and safety.
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