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

Keller JJ 1 , Ooijevaar RE 2 , Hvas CL 3 , Terveer EM 2 , Lieberknecht SC 4 , Högenauer C 5 Show all authors , Arkkila P 6 , Sokol H 7 , Gridnyev O 8 , Mégraud F 9 , Kump PK 5 , Nakov R 10 , Goldenberg SD 11 , Satokari R 12 , Tkatch S 13 , Sanguinetti M 14 , Cammarota G 15 , Dorofeev A 16 , Gubska O 17 , Ianiro G 15 , Mattila E 12 , Arasaradnam RP 18 , Sarin SK 19 , Sood A 20 , Putignani L 21 , Alric L 22 , Baunwall SMD 3 , Kupcinskas J 23 , Link A 24 , Goorhuis AG 25 , Verspaget HW 2 , Ponsioen C 26 , Hold GL 27 , Tilg H 28 , Kassam Z 29 , Kuijper EJ 2 , Gasbarrini A 15 , Mulder CJJ 2 , Williams HRT 30 , Vehreschild MJGT 4

Affiliations 

  • 1 Department of Gastroenterology, Haaglanden Medical Center, The Hague, The Netherlands
  • 2 Netherlands Donor Feces Bank, Leiden University Medical Center, Leiden, The Netherlands
  • 3 Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus, Denmark
  • 4 Department of Internal Medicine II, University Hospital Frankfurt, Frankfurt am Main, Germany
  • 5 Division of Gastroenterology and Hepatology, Medical University of Graz, Graz, Austria
  • 6 Department of Gastroenterology, Helsinki University Hospital and Helsinki University, Helsinki, Finland
  • 7 Gastroenterology Department, Saint Antoine Hospital, Paris, France
  • 8 L.T. Malaya Therapy, National Institute of the National Academy of Medical Sciences of Ukraine,  Kyiv, Ukraine
  • 9 INSERM U1053, University of Bordeaux and Bacteriology Laboratory, Pellegrin Hospital, Bordeaux, France
  • 10 Clinic of Gastroenterology, Tsaritsa Yoanna University Hospital, Sofia, Bulgaria
  • 11 Centre for Clinical Infection and Diagnostics Research (CIDR), King's College London and Guy's and St Thomas' NHS Foundation Trust, London, UK
  • 12 Human Microbiome Research Program, Faculty of Medicine, University of Helsinki, Helsinki, Finland
  • 13 Ukranian Scientific and Practical Center of Endocrine Surgery, Transplantation of Endocrine Organs and TissuesA, Kyiv, Ukraine
  • 14 Dipartimento di Scienze di Laboratorio e Infettivologiche, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy
  • 15 Gastroenterology Area, Fondazione Policlinico Universitario Gemelli, Rome, Italy
  • 16 Department of Internal Medicine, National Medical Academy of Postgraduate Education n.a. P.L. Shupic, Kiev, Ukraine
  • 17 Department of Therapy, Infectious Diseases and Dermatology Postgraduate Education, Bogomolets National Medical University, Kyiv, Ukraine
  • 18 Department of Academic Gastroenterology, University Hospital Coventry and Warwick, Coventry, UK
  • 19 Department of Hepatology, Institute of Liver and Biliary Sciences, New Delhi, India
  • 20 Department of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana, India
  • 21 Department of Laboratories, Bambino Gesù Children's Hospital, Rome, Italy
  • 22 Department of Internal Medicine and Digestive Diseases, IRD Toulouse 3 University, Toulouse, France
  • 23 Department of Gastroenterology and Institute for Digestive Research, Lithuanian University of Health Sciences, Kaunas, Lithuania
  • 24 Department of Gastroenterology, Hepatology and Infectious Diseases, Otto-von-Guericke University, Magdeburg, Germany
  • 25 Department of Internal Medicine, Amsterdam University Medical Centers, Amsterdam, The Netherlands
  • 26 Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, Amsterdam, The Netherlands
  • 27 Microbiome Research Centre, St. George and Sutherland Clinical School, University of New South Wales, Sydney, New South Wales, Australia
  • 28 Department of Gastroenterology, Hepatology, Endocrinology and Metabolism, Medical University Innsbruck, Innsbruck, Austria
  • 29 Finch Therapeutics, Somerville, Massachusetts, USA
  • 30 Faculty of Medicine, Imperial College London, London, UK
United European Gastroenterol J, 2021 Mar;9(2):229-247.
PMID: 33151137 DOI: 10.1177/2050640620967898

Abstract

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.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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