TY - JOUR
T1 - A standardised model for stool banking for faecal microbiota transplantation: a consensus report from a multidisciplinary UEG working group
AU - Keller, Josbert J.
AU - Ooijevaar, Rogier E.
AU - Hvas, Christian L.
AU - Terveer, Elisabeth M.
AU - Lieberknecht, Simone C.
AU - Högenauer, Christoph
AU - Arkkila, Perttu
AU - Sokol, Harry
AU - Gridnyev, Oleksiy
AU - Mégraud, Francis
AU - Kump, Patrizia K.
AU - Nakov, Radislav
AU - Goldenberg, Simon D.
AU - Satokari, Reetta
AU - Tkatch, Sergiy
AU - Sanguinetti, Maurizio
AU - Cammarota, Giovanni
AU - Dorofeev, Andrey
AU - Gubska, Olena
AU - Laniro, Gianluca
AU - Mattila, Eero
AU - Arasaradnam, Ramesh P.
AU - Sarin, Shiv K.
AU - Sood, Ajit
AU - Putignani, Lorenza
AU - Alric, Laurent
AU - Baunwall, Simon M. D.
AU - Kupcinskas, Juozas
AU - Link, Alexander
AU - Goorhuis, Abraham G.
AU - Verspaget, Hein W.
AU - Ponsioen, Cyriel
AU - Hold, Georgina L.
AU - Tilg, Herbert
AU - Kassam, Zain
AU - Kuijper, Ed J.
AU - Gasbarrini, Antonio
AU - Mulder, Chris J. J.
AU - Williams, Horace R. T.
AU - Vehreschild, Maria J. G. T.
N1 - Funding Information:
The templates of standard operational procedures are based on SOPs provided by The Netherlands Donor Feces Bank and Aarhus University Hospital, Aarhus, Denmark. The presented informed consent form for healthy donors was provided by the Cologne Stool Bank, Germany. The working group was hosted by the European Helicobacter and Microbiota Study Group (EHMSG), which is a member society of UEG. Delegates of the ESCMID study group for Host and Microbiota Interaction (ESGHAMI) group participated in the working group. The working group was supported by Romana Ko?nig. The working group was supported by an UEG standards and guidelines activity grant.
Publisher Copyright:
© 2020 The Authors. United European Gastroenterology Journal published by Wiley Periodicals LLC. on behalf of United European Gastroenterology.
Copyright:
Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2021/3
Y1 - 2021/3
N2 - Background: Faecal microbiota transplantation is an emerging therapeutic option, particularly for the treatment of recurrent Clostridioides difficile infection. Stool banks that organise recruitment and screening of faeces 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 faecal 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 faecal 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 faecal microbiota transplantation by stool banks in concordance with our guidance document will enable quality assurance and guarantee the availability of donor faeces preparations for patients.
AB - Background: Faecal microbiota transplantation is an emerging therapeutic option, particularly for the treatment of recurrent Clostridioides difficile infection. Stool banks that organise recruitment and screening of faeces 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 faecal 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 faecal 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 faecal microbiota transplantation by stool banks in concordance with our guidance document will enable quality assurance and guarantee the availability of donor faeces preparations for patients.
KW - Clostridioides difficile
KW - faecal microbiota transplantation
KW - legislation
KW - stool bank
UR - https://www.scopus.com/pages/publications/85102266067
U2 - 10.1177/2050640620967898
DO - 10.1177/2050640620967898
M3 - Article
C2 - 33151137
SN - 2050-6406
VL - 9
SP - 229
EP - 247
JO - United European gastroenterology journal
JF - United European gastroenterology journal
IS - 2
ER -
SDG 10 Reduced Inequalities