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 - Ianiro, 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.
PY - 2021
Y1 - 2021
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 - Age Factors
KW - Biological Specimen Banks
KW - Clostridioides difficile
KW - Clostridium Infections
KW - Contraindications, Procedure
KW - Donor Selection
KW - Fecal Microbiota Transplantation
KW - Feces
KW - Humans
KW - Immunocompromised Host
KW - Informed Consent
KW - Quality Assurance, Health Care
KW - Recurrence
KW - Specimen Handling
KW - faecal microbiota transplantation
KW - legislation
KW - stool bank
KW - Age Factors
KW - Biological Specimen Banks
KW - Clostridioides difficile
KW - Clostridium Infections
KW - Contraindications, Procedure
KW - Donor Selection
KW - Fecal Microbiota Transplantation
KW - Feces
KW - Humans
KW - Immunocompromised Host
KW - Informed Consent
KW - Quality Assurance, Health Care
KW - Recurrence
KW - Specimen Handling
KW - faecal microbiota transplantation
KW - legislation
KW - stool bank
UR - http://hdl.handle.net/10807/204646
U2 - 10.1177/2050640620967898
DO - 10.1177/2050640620967898
M3 - Article
SN - 2050-6406
VL - 9
SP - 229
EP - 247
JO - United European Gastroenterology Journal
JF - United European Gastroenterology Journal
ER -