A standardised model for stool banking for faecal microbiota transplantation: a consensus report from a multidisciplinary UEG working group

Abstract

Background Fecal microbiota transplantation is an emerging therapeutic option, particularly for the treatment of recurrent Clostridioides difficile infection. Stool banks that organise recruitment and screening of feces donors are being embedded within the regulatory frameworks described in the European Union Tissue and Cells Directive and the technical guide to the quality and safety of tissue and cells for human application, published by the European Council. Objective Several European and international consensus statements concerning fecal microbiota transplantation have been issued. While these documents provide overall guidance, we aim to provide a detailed description of all processes that relate to the collection, handling and clinical application of human donor stool in this document. Methods Collaborative subgroups of experts on stool banking drafted concepts for all domains pertaining to stool banking. During a working group meeting in the United European Gastroenterology Week 2019 in Barcelona, these concepts were discussed and finalised to be included in our overall guidance document about fecal microbiota transplantation. Results A guidance document for all domains pertaining to stool banking was created. This document includes standard operating manuals for several processes involved with stool banking, such as handling of donor material, storage and donor screening. Conclusion The implementation of fecal microbiota transplantation by stool banks in concordance with our guidance document will enable quality assurance and guarantee the availability of donor feces preparations for patients.

Fecal microbiota transplantation for irritable bowel syndrome: An intervention for the 21st century

“…A recently published consensus report from a multidisciplinary United European Gastroenterology working group did not classify voluntarily donated material (feces) as a drug. Instead, it was recommended to be collected, handled, and used according to the standards defined by the EU Commission in EU Tissue and Cells Directive 2004/23/EC[ 21 , 57 ].…”

“…Transplanting the intestinal microbiome ( via feces) from a healthy subject with normal bowel function to patients — so-called fecal microbiota transplantation (FMT) — was applied for the first time by the Chinese physician Ge Hong in the fourth century for treating severe diarrhea and malaria[ 18 ]. In the present era, FMT represents an effective treatment for Clostridium difficile infection (CDI) and is also a promising invention for other diseases[ 19 - 21 ].…”

Ten-Year Follow-Up of Patients Treated with Fecal Microbiota Transplantation for Recurrent Clostridioides difficile Infection from a Randomized Controlled Trial and Review of the Literature

“…In particular, conclusions about the long-term effects of FMT in young patients on the development of malignancies, neurodegenerative, or autoimmune disorders cannot be drawn based on our study and the available literature. More prospective studies addressing the long-term follow-up after FMT are needed, preferably in national or even international registries [24]. Combining long-term follow-up data with microbiota analysis of samples of used FMT suspensions and its respective recipients in the case of adverse events may result in further understanding of the safety and long-term effects of FMT in the future.…”

Romanian National Guideline on Translating Fecal Microbiota Transplantation Applications related to Clostridioides difficile Infections into the Local Clinical Practice

“…Consequently, our aim was to create a national guideline for FMT in Romania, adapting the currently available guideline of the British Society of Gastroenterology and Healthcare Infection Society Guideline [13], the recent Consensus report of the UEG working group on stool banking [14], and following the recommendations of the European Consensus on FMT [12] in clinical practice, taking into account the local conditions and also the need to adapt FMT practice in the context of COVID-19 pandemic [15]. Moreover, following this initiative, stool banking can be consequently developed and the extension and adaptation of FMT for pediatric use in local conditions could also be established.…”