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.

Abstract

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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