Intesto - Gastroenterology practice and Crohn-colitis Center, Bern, Switzerland.
Department of Gastroenterology and Hepatology, University Medical Clinic, Baselland Canton Hospital, Liestal, Switzerland.
Swiss Med Wkly. 2023 Aug 25;153:40100. doi: 10.57187/smw.2023.40100.
Faecal microbiota transplantation (FMT) is an established therapy for recurrent C. difficile infection, and recent studies have reported encouraging results of FMT in patients with ulcerative colitis. Few international consensus guidelines exist for this therapy, and thus FMT policies and practices differ among European countries. As of 2019, stool transplants are considered a non-standardised medicinal product in Switzerland, and a standardised production process requires authorisation by the Swiss Agency for Therapeutic Products. This authorisation leads to prolonged administrative procedures and increasing costs, which reduces treatment accessibility. In particular, patients with ulcerative colitis in Switzerland can only benefit from FMT off-label, even though it is a valid therapeutic option. Therefore, this study summarised the available data on FMT and established a framework for the standardised use of FMT.
A panel of Swiss gastroenterologists with a special interest in inflammatory bowel disease was established to identify the current key issues of FMT. After a comprehensive review of the literature, statements were formulated about FMT indications, donor screening, stool transplant preparation and administration, and safety aspects. The panel then voted on the statements following the Delphi process; the statements were reformulated and revoted until a consensus was reached. The manuscript was then reviewed by an infectiologist (the head of Lausanne's FMT centre).
The established statements are summarised in the supplementary tables in the appendix to this paper. The working group hopes these will help standardise FMT practice in Switzerland and contribute to making faecal microbiota transplantation a safe and accessible treatment for patients with recurrent C. difficile infections and selected patients with ulcerative colitis, as well as other indications in the future.
粪便微生物群移植（FMT）是复发性艰难梭菌感染的一种既定疗法，最近的研究报告了 FMT 治疗溃疡性结肠炎患者的令人鼓舞的结果。针对这种治疗方法，目前仅存在少数国际共识指南，因此欧洲各国的 FMT 政策和实践存在差异。截至 2019 年，在瑞士，粪便移植被视为一种非标准化药物，而标准化生产过程需要获得瑞士药品管理局的授权。这种授权会导致行政程序延长和成本增加，从而降低了治疗的可及性。特别是，瑞士的溃疡性结肠炎患者只能接受 FMT 的标签外治疗，尽管这是一种有效的治疗选择。因此，本研究总结了 FMT 的现有数据，并为 FMT 的标准化使用建立了一个框架。
成立了一个由对炎症性肠病特别感兴趣的瑞士胃肠病学家组成的小组，以确定 FMT 的当前关键问题。在对文献进行全面审查后，针对 FMT 的适应证、供体筛选、粪便移植准备和管理以及安全性方面制定了陈述。然后，小组采用德尔菲法对陈述进行投票；对陈述进行重新制定和再次投票，直到达成共识。然后，由一位感染病学家（洛桑 FMT 中心的负责人）对该手稿进行审查。
在本文附录的补充表中总结了已确定的陈述。工作组希望这些陈述有助于在瑞士标准化 FMT 实践，并有助于使粪便微生物群移植成为复发性艰难梭菌感染和选定的溃疡性结肠炎患者以及未来其他适应证的安全且可及的治疗方法。
