Treatment With Fecal Microbiota Transplantation: The Need for Complete Methodological Reporting for Clinical Trials

Editorials4 July 2017Treatment With Fecal Microbiota Transplantation: The Need for Complete Methodological Reporting for Clinical TrialsVincent B. Young, MD, PhDVincent B. Young, MD, PhDFrom University of Michigan, Ann Arbor, Michigan.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/M17-1157 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail The virtual explosion of research articles related to the role of the human microbiome in health and disease has opened new avenues to understanding the pathogenesis of a wide variety of conditions (1). Along with interest in potential pathogenic roles for altered structure and function of the indigenous microbiota, there is a corresponding pursuit of novel therapeutics to intentionally change the microbiota to restore health (2). Whereas various methods have been proposed to therapeutically modulate the microbiome, ranging from probiotics and prebiotics to selective antibiotics, the transfer of the intestinal microbiota from a healthy individual through fecal microbiota transplantation (FMT) ...References1. Young VB. The role of the microbiome in human health and disease: an introduction for clinicians. BMJ. 2017;356:j831. [PMID: 28298355] doi:10.1136/bmj.j831 CrossrefMedlineGoogle Scholar2. Young VB. Therapeutic manipulation of the microbiota: past, present, and considerations for the future. Clin Microbiol Infect. 2016;22:905-909. [PMID: 27619640] doi:10.1016/j.cmi.2016.09.001 CrossrefMedlineGoogle Scholar3. Fuentes S, de Vos WM. How to manipulate the microbiota: fecal microbiota transplantation. Adv Exp Med Biol. 2016;902:143-53. [PMID: 27161356] doi:10.1007/978-3-319-31248-4_10 CrossrefMedlineGoogle Scholar4. Rao K, Safdar N. Fecal microbiota transplantation for the treatment of Clostridium difficile infection. J Hosp Med. 2016;11:56-61. [PMID: 26344412] doi:10.1002/jhm.2449 CrossrefMedlineGoogle Scholar5. Brandt LJ. Fecal microbiota transplant: respice, adspice, prospice. J Clin Gastroenterol. 2015;49 Suppl 1:S65-8. [PMID: 26447968] doi:10.1097/MCG.0000000000000346 CrossrefMedlineGoogle Scholar6. Bafeta A, Yavchitz A, Riveros C, Batista R, Ravaud P. Methods and reporting studies assessing fecal microbiota transplantation. A systematic review. Ann Intern Med. 2017;167:34-9. doi:10.7326/M16-2810 LinkGoogle Scholar7. Vyas D, Aekka A, Vyas A. Fecal transplant policy and legislation. World J Gastroenterol. 2015;21:6-11. [PMID: 25574076] doi:10.3748/wjg.v21.i1.6 CrossrefMedlineGoogle Scholar8. Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med. 2010;152:726-32. [PMID: 20335313]. doi:10.7326/0003-4819-152-11-201006010-00232 LinkGoogle Scholar9. König J, Siebenhaar A, Högenauer C, Arkkila P, Nieuwdorp M, Norén T, et al. Consensus report: faecal microbiota transfer—clinical applications and procedures. Aliment Pharmacol Ther. 2017;45:222-239. [PMID: 27891639] doi:10.1111/apt.13868 CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAffiliations: From University of Michigan, Ann Arbor, Michigan.Grant Support: Work in the author's laboratory is supported by cooperative agreements from the National Institutes of Health (U01 AI124255 and U19 AI116482).Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M17-1157.Corresponding Author: Vincent B. Young, MD, PhD, Room 1520B MSRB I SPC 5666, 1150 West Medical Center Drive, Ann Arbor, MI 48109; e-mail, [email protected]edu.This article was published at Annals.org on 23 May 2017. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoMethods and Reporting Studies Assessing Fecal Microbiota Transplantation Aïda Bafeta , Amelie Yavchitz , Carolina Riveros , Rui Batista , and Philippe Ravaud Metrics 4 July 2017Volume 167, Issue 1Page: 61-62KeywordsClinical trial reportingDisclosureFecal microbiota transplantInfectious diseasesInflammatory bowel diseaseMicrobiomeRandomized trialsResearch laboratoriesSystematic reviewsTransplantation ePublished: 23 May 2017 Issue Published: 4 July 2017 Copyright & PermissionsCopyright © 2017 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...