Kabage Amanda J, Haselhorst Parker J, Khoruts Alexander
Division of Gastroenterology, Hepatology, and Nutrition, Microbiota Therapeutics Program, University of Minnesota, Minneapolis, MN, USA.
Gut Microbes. 2025 Dec;17(1):2508950. doi: 10.1080/19490976.2025.2508950. Epub 2025 Jun 18.
Human stool-based products composed of fecal microbiota are a new frontier of medical therapeutics development. The development of standardized manufacturing protocols of donor microbiota has transformed fecal microbiota transplantation (FMT) from a crude and rarely used procedure to a widely accepted and highly effective option for treatment infections. There is also a growing interest in using microbiota transplant therapies for multiple other clinical indications. In this manuscript, we review the logistical challenges experienced by various stool banks and our own group in establishing and administering a stool donor program. Furthermore, we explore and highlight the multiple ethical considerations that are ultimately essential to product safety and efficacy and propose basic principles that are necessary to maintain stool donor program integrity.
由粪便微生物群组成的基于人类粪便的产品是医学治疗学发展的一个新前沿。供体微生物群标准化制造方案的发展已将粪便微生物群移植（FMT）从一种粗糙且很少使用的程序转变为一种广泛接受且高效的治疗感染的选择。人们对将微生物群移植疗法用于多种其他临床适应症的兴趣也在日益增加。在本手稿中，我们回顾了各个粪便库以及我们自己团队在建立和管理粪便供体计划过程中遇到的后勤挑战。此外，我们探讨并强调了对产品安全性和有效性至关重要的多重伦理考量，并提出了维持粪便供体计划完整性所必需的基本原则。
