Although faecal microbiota transplantation (FMT) has a well-established role in the treatment of recurrent Clostridioides difficile infection (CDI), its widespread dissemination is limited by several obstacles, including lack of dedicated centres, difficulties with donor recruitment and complexities related to regulation and safety monitoring. Given the considerable burden of CDI on global healthcare systems, FMT should be widely available to most centres.
Stool banks may guarantee reliable, timely and equitable access to FMT for patients and a traceable workflow that ensures safety and quality of procedures. In this consensus project, FMT experts from Europe, North America and Australia gathered and released statements on the following issues related to the stool banking: general principles, objectives and organisation of the stool bank; selection and screening of donors; collection, preparation and storage of faeces; services and clients; registries, monitoring of outcomes and ethical issues; and the evolving role of FMT in clinical practice,
Consensus on each statement was achieved through a Delphi process and then in a plenary face-to-face meeting. For each key issue, the best available evidence was assessed, with the aim of providing guidance for the development of stool banks in order to promote accessibility to FMT in clinical practice.
- clostridioides difficile
- fecal microbiota transplantation
- stool bank
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
Statistics from Altmetric.com
GC and GI are joint first authors.
Twitter @GiovanniCammar9, @gianluca1aniro
Contributors GC conceived the idea and programme for the project. GC, and GI organised and developed the project. GC, GI and CRK selected the expert panel and established the main topics. All panel members were involved in developing the statements with supporting evidence and drafted the text of discussion relevant to their statements. GC, GI, CRK, BHM, JRA, ZK and LP wrote the initial draft of the manuscript. All panel members read and revised the manuscript for important intellectual content and approved the final manuscript.
Funding The project was in part funded by the Catholic University of Rome, Line D-1 research funding.
Competing interests JRA received grants from, and consulted for, Finch Therapeutics and Merck and Co. GC, GI, FS and LM received grants in the field of faecal microbiota transplantation (FMT) from the Italian Ministry of Health. SPC received fees from Shire, Ferring, Microbiotica, Pfizer and Janssen. MF is consultant to Finch Therapeutics Group and DSMB member for Rebiotix. AH has served as consultant, advisory board member or speaker for AbbVie, Atlantic, Bristol-Myers Squibb, Celltrion, Falk, Ferring, Janssen, MSD, Napp Pharmaceuticals, Pfizer, Pharmacosmos, Shire and Takeda; she also serves on the Global Steering Committee for Genentech. ZK is an employee/shareholder at Finch Therapeutics and advisor/consultant at OpenBiome. JK and EJK received research grants from Vedanta Bioscences, Boston, USA. CPK is a clinical site for the PRISM FMT trial conducted by Finch Therapeutics. HS received unrestricted study grants: Danone, Biocodex, Enterome; board membership, consultancy or lecture fees: Carenity, Abbvie, Astellas, Danone, Ferring, Mayoly Spindler, MSD, Novartis, Roche, Tillots, Enterome, Maat, BiomX, Biose, Novartis, Takeda; co-funder of Exeliom Biosciences. All the remaining authors have nothing to declare.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.