Aïda Bafeta, PhD; Amelie Yavchitz, MD, PhD; Carolina Riveros, MSc; Rui Batista, PharmD; Philippe Ravaud, MD, PhD
Acknowledgment: The authors thank Laura Smales (BioMedEditing, Toronto, Ontario, Canada) for editing the manuscript.
Disclosures: Authors have disclosed no conflicts of interest. Forms can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M16-2810.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that she has no financial relationships or interests to disclose. Darren B. Taichman, MD, PhD, Executive Deputy Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer and Johnson & Johnson.
Reproducible Research Statement:Study protocol: Available from Dr. Bafeta (e-mail, email@example.com). Statistical code: Not applicable. Data set: See tables, figures, and supplementary material for all relevant data.
Requests for Single Reprints: Aïda Bafeta, PhD, Centre d'Epidémiologie Clinique, INSERM U1153, Hôpital Hôtel-Dieu, 1 place du Parvis Notre Dame, 75004 Paris, France; e-mail, firstname.lastname@example.org.
Current Author Addresses: Drs. Bafeta, Yavchitz, and Ravaud and Ms. Riveros: Centre d'Epidémiologie Clinique, INSERM U1153, Hôpital Hôtel-Dieu, 1 place du Parvis Notre Dame, 75004 Paris, France.
Dr. Batista: Service de pharmacie Clinique, Hôpitaux Universitaires Paris Centre, 27 rue du Faubourg Saint-Jacques, 75014 Paris, France.
Author Contributions: Conception and design: A. Bafeta, R. Batista, P. Ravaud.
Analysis and interpretation of the data: A. Bafeta, A. Yavchitz, C. Riveros, R. Batista, P. Ravaud.
Drafting of the article: A. Bafeta, A. Yavchitz, R. Batista, P. Ravaud.
Critical revision of the article for important intellectual content: A. Bafeta, R. Batista, P. Ravaud.
Final approval of the article: A. Bafeta, C. Riveros, R. Batista, P. Ravaud.
Administrative, technical, or logistic support: P. Ravaud.
Collection and assembly of data: A. Bafeta, A. Yavchitz, C. Riveros.
Fecal microbiota transplantation (FMT) could be a novel treatment option for several chronic diseases associated with altered gut microbiota.
To examine the conduct and reporting of studies assessing FMT.
Cochrane Central Register of Controlled Trials, PubMed, EMBASE, and Web of Science from inception to 31 January 2017.
Two reviewers independently examined titles and abstracts to identify all English-language reports of human clinical studies assessing the safety or efficacy of FMT.
Three reviewers independently assessed study types and characteristics and the reporting of important methodological components of the FMT intervention.
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.
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.
Key components of FMT interventions, which are necessary to replicate and understand study findings about efficacy and safety, are poorly reported.
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Bafeta A, Yavchitz A, Riveros C, Batista R, Ravaud P. Methods and Reporting Studies Assessing Fecal Microbiota Transplantation: A Systematic Review. Ann Intern Med. [Epub ahead of print 23 May 2017]:. doi: 10.7326/M16-2810
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Published: Ann Intern Med. 2017.
Gastroenterology/Hepatology, Inflammatory Bowel Disease.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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