From 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.
Ann Intern Med. 2017 Jul 4;167(1):34-39. doi: 10.7326/M16-2810. Epub 2017 May 23.
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.
No specific funding.
粪便微生物群移植（FMT）可能是一种治疗与肠道微生物群改变相关的多种慢性疾病的新方法。
检查评估 FMT 的研究的实施和报告情况。
考克兰对照试验中心注册库、PubMed、EMBASE 和 Web of Science，从建库到 2017 年 1 月 31 日。
两名评审员独立查看标题和摘要，以确定所有评估 FMT 安全性或疗效的人类临床研究的英文报告。
三名评审员独立评估研究类型和特征，以及 FMT 干预措施的重要方法学组成部分的报告情况。
已发表的 85 份报告中，大多数（84%）涉及 FMT 治疗艰难梭菌感染或炎症性肠病，且大多数（87%）为非随机对照试验。在已发表的研究中，没有报告的重要方法学组成部分包括以下内容：供体的入选标准（47%）、用于收集粪便的材料和收集时间（96%）、粪便保存方法（76%）、使用粪便的量和类型（例如，新鲜或冷冻）以及粪便保存时间（67%）。许多（58%）未报告微生物群落组成的分析。
缺乏关于 FMT 最重要的方法学组成部分的普遍共识，无法评估研究的实际实施情况，也无法评估发表过程是否影响报告的完整性。
FMT 干预措施的关键组成部分，对于复制和理解关于疗效和安全性的研究结果至关重要，但报告情况很差。
无特定资金来源。
