Jørgensen Simon M D, Hansen Mette M, Erikstrup Christian, Dahlerup Jens F, Hvas Christian L
Departments of aHepatology and Gastroenterology bClinical Immunology, Aarhus University Hospital, Aarhus, Denmark.
Eur J Gastroenterol Hepatol. 2017 Nov;29(11):e36-e45. doi: 10.1097/MEG.0000000000000958.
Faecal microbiota transplantation (FMT) is currently being established as a second-line treatment for recurrent Clostridium difficile infection. FMT is further being considered for other infectious and inflammatory conditions. Safe and reproducible methods for donor screening, laboratory processing and clinical application of FMT are warranted.
Here, we describe the development of a complete clinical application framework for FMT. The framework has been developed to comply with the European Tissue Act, thus considering donor faeces for FMT comparable to a human tissue and not a drug.
Recruitment and screening of potential faeces donors took place in the public blood donor setting and consisted of questionnaires, blood sampling and faecal sample analysis. Once approved, and following their written informed consent, eligible donors were invited for voluntary faecal donation. Laboratory processing protocols describe the initial handling, cryopreservation and thawing for clinical application. The clinical FMT procedures took place in a gastroenterological setting using a nasojejunal tube or colonoscopy, and follow-ups were performed at 1, 8 and 26 weeks after FMT. Complete traceability of essential equipment, faecal samples and donor-recipient matching data will be maintained and secured for 30 years.
A clinical FMT service should be consolidated by a complete documentation system that complies with the European Tissue Act. In this paper, we provide a description of such a framework.
粪便微生物群移植（FMT）目前正在成为复发性艰难梭菌感染的二线治疗方法。FMT还被考虑用于其他感染性和炎症性疾病。因此，需要有安全且可重复的方法用于FMT的供体筛查、实验室处理及临床应用。
在此，我们描述了一个完整的FMT临床应用框架的开发情况。该框架的开发符合欧洲组织法，因此将用于FMT的供体粪便视为一种人体组织而非药物。
在公共献血场所招募并筛选潜在粪便供体，包括问卷调查、血液采样和粪便样本分析。一旦获得批准，并在获得其书面知情同意后，邀请符合条件的供体进行自愿粪便捐献。实验室处理方案描述了临床应用的初始处理、冷冻保存和解冻过程。临床FMT程序在胃肠病学环境中使用鼻空肠管或结肠镜进行，并在FMT后1、8和26周进行随访。关键设备、粪便样本和供体-受体匹配数据的完整可追溯性将被维护并保存30年。
临床FMT服务应由符合欧洲组织法的完整文件系统来巩固。在本文中，我们描述了这样一个框架。
