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

Josbert J Keller^{1

2

3}, Rogier E Ooijevaar^{3

4}, Christian L Hvas⁵, Elisabeth M Terveer^{3

6}, Simone C Lieberknecht⁷, Christoph Högenauer⁸, Perttu Arkkila⁹, Harry Sokol^{10

11

12}, Oleksiy Gridnyev¹³, Francis Mégraud¹⁴, Patrizia K Kump⁸, Radislav Nakov¹⁵, Simon D Goldenberg¹⁶, Reetta Satokari¹⁷, Sergiy Tkatch¹⁸, Maurizio Sanguinetti¹⁹, Giovanni Cammarota²⁰, Andrey Dorofeev²¹, Olena Gubska²², Gianluca Ianiro²⁰, Eero Mattila¹⁷, Ramesh P Arasaradnam²³, Shiv K Sarin²⁴, Ajit Sood²⁵, Lorenza Putignani²⁶, Laurent Alric²⁷, Simon M D Baunwall⁵, Juozas Kupcinskas²⁸, Alexander Link²⁹, Abraham G Goorhuis³⁰, Hein W Verspaget^{3

31}, Cyriel Ponsioen⁴, Georgina L Hold³², Herbert Tilg³³, Zain Kassam³⁴, Ed J Kuijper^{3

6

35

36}, Antonio Gasbarrini²⁰, Chris J J Mulder^{3

4}, Horace R T Williams³⁷, Maria J G T Vehreschild^{7

36

38

39}

Affiliations

¹ Department of Gastroenterology, Haaglanden Medical Center, The Hague, The Netherlands.
² Department of Gastroenterology and Hepatology, Leiden University Medical Center, Leiden, The Netherlands.
³ Netherlands Donor Feces Bank, Leiden University Medical Center, Leiden, The Netherlands.
⁴ Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, Amsterdam, The Netherlands.
⁵ Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus, Denmark.
⁶ Department of Medical Microbiology, Leiden University Medical Center, Leiden, The Netherlands.
⁷ Department of Internal Medicine II, University Hospital Frankfurt, Frankfurt am Main, Germany.
⁸ Division of Gastroenterology and Hepatology, Medical University of Graz, Graz, Austria.
⁹ Department of Gastroenterology, Helsinki University Hospital and Helsinki University, Helsinki, Finland.
¹⁰ Gastroenterology Department, Saint Antoine Hospital, Paris, France.
¹¹ INRA, UMR1319 Micalis, AgroParisTech, Jouy-en-Josas, France.
¹² French Group of Fecal Microbiota Transplantation (GFTF), Paris, France.
¹³ L.T. Malaya Therapy, National Institute of the National Academy of Medical Sciences of Ukraine, Kyiv, Ukraine.
¹⁴ INSERM U1053, University of Bordeaux and Bacteriology Laboratory, Pellegrin Hospital, Bordeaux, France.
¹⁵ Clinic of Gastroenterology, Tsaritsa Yoanna University Hospital, Sofia, Bulgaria.
¹⁶ Centre for Clinical Infection and Diagnostics Research (CIDR), King's College London and Guy's and St Thomas' NHS Foundation Trust, London, UK.
¹⁷ Human Microbiome Research Program, Faculty of Medicine, University of Helsinki, Helsinki, Finland.
¹⁸ Ukranian Scientific and Practical Center of Endocrine Surgery, Transplantation of Endocrine Organs and TissuesA, Kyiv, Ukraine.
¹⁹ Dipartimento di Scienze di Laboratorio e Infettivologiche, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
²⁰ Gastroenterology Area, Fondazione Policlinico Universitario Gemelli, Rome, Italy.
²¹ Department of Internal Medicine, National Medical Academy of Postgraduate Education n.a. P.L. Shupic, Kiev, Ukraine.
²² Department of Therapy, Infectious Diseases and Dermatology Postgraduate Education, Bogomolets National Medical University, Kyiv, Ukraine.
²³ Department of Academic Gastroenterology, University Hospital Coventry and Warwick, Coventry, UK.
²⁴ Department of Hepatology, Institute of Liver and Biliary Sciences, New Delhi, India.
²⁵ Department of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana, India.
²⁶ Department of Laboratories, Bambino Gesù Children's Hospital, Rome, Italy.
²⁷ Department of Internal Medicine and Digestive Diseases, IRD Toulouse 3 University, Toulouse, France.
²⁸ Department of Gastroenterology and Institute for Digestive Research, Lithuanian University of Health Sciences, Kaunas, Lithuania.
²⁹ Department of Gastroenterology, Hepatology and Infectious Diseases, Otto-von-Guericke University, Magdeburg, Germany.
³⁰ Department of Internal Medicine, Amsterdam University Medical Centers, Amsterdam, The Netherlands.
³¹ LUMC Biobank, Leids Universitair Medisch Centrum, Leiden, The Netherlands.
³² Microbiome Research Centre, St. George and Sutherland Clinical School, University of New South Wales, Sydney, New South Wales, Australia.
³³ Department of Gastroenterology, Hepatology, Endocrinology and Metabolism, Medical University Innsbruck, Innsbruck, Austria.
³⁴ Finch Therapeutics, Somerville, Massachusetts, USA.
³⁵ Centre for Microbiota Analysis and Therapeutics, Leiden University Medical Centre, Leiden, The Netherlands.
³⁶ ESCMID Study Group for Host and Microbiota Interaction (ESGHAMI), Basel, Switzerland.
³⁷ Faculty of Medicine, Imperial College London, London, UK.
³⁸ Department I of Internal Medicine, University of Cologne, Cologne, Germany.
³⁹ German Centre for Infection Research (DZIF), Partner site Bonn-Cologne, Germany.

PMID: 33151137
PMCID: PMC8259288
DOI: 10.1177/2050640620967898

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

Josbert J Keller et al. United European Gastroenterol J. 2021 Mar.

. 2021 Mar;9(2):229-247.

doi: 10.1177/2050640620967898. Epub 2021 Mar 9.

Authors

Affiliations

¹ Department of Gastroenterology, Haaglanden Medical Center, The Hague, The Netherlands.
² Department of Gastroenterology and Hepatology, Leiden University Medical Center, Leiden, The Netherlands.
³ Netherlands Donor Feces Bank, Leiden University Medical Center, Leiden, The Netherlands.
⁴ Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, Amsterdam, The Netherlands.
⁵ Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus, Denmark.
⁶ Department of Medical Microbiology, Leiden University Medical Center, Leiden, The Netherlands.
⁷ Department of Internal Medicine II, University Hospital Frankfurt, Frankfurt am Main, Germany.
⁸ Division of Gastroenterology and Hepatology, Medical University of Graz, Graz, Austria.
⁹ Department of Gastroenterology, Helsinki University Hospital and Helsinki University, Helsinki, Finland.
¹⁰ Gastroenterology Department, Saint Antoine Hospital, Paris, France.
¹¹ INRA, UMR1319 Micalis, AgroParisTech, Jouy-en-Josas, France.
¹² French Group of Fecal Microbiota Transplantation (GFTF), Paris, France.
¹³ L.T. Malaya Therapy, National Institute of the National Academy of Medical Sciences of Ukraine, Kyiv, Ukraine.
¹⁴ INSERM U1053, University of Bordeaux and Bacteriology Laboratory, Pellegrin Hospital, Bordeaux, France.
¹⁵ Clinic of Gastroenterology, Tsaritsa Yoanna University Hospital, Sofia, Bulgaria.
¹⁶ Centre for Clinical Infection and Diagnostics Research (CIDR), King's College London and Guy's and St Thomas' NHS Foundation Trust, London, UK.
¹⁷ Human Microbiome Research Program, Faculty of Medicine, University of Helsinki, Helsinki, Finland.
¹⁸ Ukranian Scientific and Practical Center of Endocrine Surgery, Transplantation of Endocrine Organs and TissuesA, Kyiv, Ukraine.
¹⁹ Dipartimento di Scienze di Laboratorio e Infettivologiche, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
²⁰ Gastroenterology Area, Fondazione Policlinico Universitario Gemelli, Rome, Italy.
²¹ Department of Internal Medicine, National Medical Academy of Postgraduate Education n.a. P.L. Shupic, Kiev, Ukraine.
²² Department of Therapy, Infectious Diseases and Dermatology Postgraduate Education, Bogomolets National Medical University, Kyiv, Ukraine.
²³ Department of Academic Gastroenterology, University Hospital Coventry and Warwick, Coventry, UK.
²⁴ Department of Hepatology, Institute of Liver and Biliary Sciences, New Delhi, India.
²⁵ Department of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana, India.
²⁶ Department of Laboratories, Bambino Gesù Children's Hospital, Rome, Italy.
²⁷ Department of Internal Medicine and Digestive Diseases, IRD Toulouse 3 University, Toulouse, France.
²⁸ Department of Gastroenterology and Institute for Digestive Research, Lithuanian University of Health Sciences, Kaunas, Lithuania.
²⁹ Department of Gastroenterology, Hepatology and Infectious Diseases, Otto-von-Guericke University, Magdeburg, Germany.
³⁰ Department of Internal Medicine, Amsterdam University Medical Centers, Amsterdam, The Netherlands.
³¹ LUMC Biobank, Leids Universitair Medisch Centrum, Leiden, The Netherlands.
³² Microbiome Research Centre, St. George and Sutherland Clinical School, University of New South Wales, Sydney, New South Wales, Australia.
³³ Department of Gastroenterology, Hepatology, Endocrinology and Metabolism, Medical University Innsbruck, Innsbruck, Austria.
³⁴ Finch Therapeutics, Somerville, Massachusetts, USA.
³⁵ Centre for Microbiota Analysis and Therapeutics, Leiden University Medical Centre, Leiden, The Netherlands.
³⁶ ESCMID Study Group for Host and Microbiota Interaction (ESGHAMI), Basel, Switzerland.
³⁷ Faculty of Medicine, Imperial College London, London, UK.
³⁸ Department I of Internal Medicine, University of Cologne, Cologne, Germany.
³⁹ German Centre for Infection Research (DZIF), Partner site Bonn-Cologne, Germany.

PMID: 33151137
PMCID: PMC8259288
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.

Keywords: Clostridioides difficile; faecal microbiota transplantation; legislation; stool bank.

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Conflict of interest statement

Josbert J. Keller and Ed J. Kuijper have received research grants from Vedanta Biosciences. Cyriel Ponsioen has received grant support from Takeda, speaker's fees from Takeda, Tillotts and Pfizer and consultancy fees from Takeda, Shire and Pliant. Radislav Nakov is in the speaker's bureau of Takeda and Pfizer. Perttu Arkkila has received a research grant from Vifor Pharma, and speaker's fee from MSD. Maria JGT Vehreschild has received research grants from 3M, Astellas Pharma, DaVolterra, Gilead Sciences, Heel, Glycom, MaaT Pharma, Merck/MSD, Organobalance, Seres Therapeutics; speaker's fees from Astellas Pharma, Basilea, Falk Foundation, Gilead Sciences, Merck/MSD, Organobalance, Pfizer and has been a consultant to Alb Fils Kliniken GmbH, Astellas Pharma, BioMerieux, DaVolterra, Ferring, MaaT Pharma, Merck/MSD and Roche. Simon D. Goldenberg reports consultancy fees from Astellas, Enterobiotix, Menarini, MSD, Pfizer and Shionogi. Oleksiy Gridnyev reports speaker's fees from Abbott and a research grant from Biocodex. Harry Sokol reports board membership, consultancy or lecture fees from Carenity, Abbvie, Astellas, Danone, Ferring, Biocodex, Mayoly Spindler, MSD, Novartis, Roche, Tillots, Enterome, Maat, BiomX, Biose, Novartis and Takeda; and is a co‐founder of Exeliom Biosciences. Zain Kassam is an employee/shareholder of Finch Therapeutics. Alexander Link reports a grant from European Commission European funds for regional development (EFRE) related to micro‐biome and FMT research. Georgina L. Hold reports consultancy fees from Ferring and Proctor and Gamble; and scientific board membership of Enterobiotix. Eero Mattila has been a scientific advisor and received lecture fees from MSD Finland. Christoph Hogenauer receives grant support from Seres Therapeutics and consultancy, or lecture fees from Abbvie, Astellas, Ferring, Falk, Janssen, Merck/MSD, Pfizer and Takeda. The other authors declare that there are no conflict of interests.

Comment in

Faecal microbiota transplants: Why do we not consider them as Advanced Therapy Medicinal Products?
Verbeke F, De Spiegeleer B. Verbeke F, et al. United European Gastroenterol J. 2021 May;9(4):519-520. doi: 10.1002/ueg2.12066. Epub 2021 May 7. United European Gastroenterol J. 2021. PMID: 33961738 Free PMC article. No abstract available.

References

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

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

Comment in

References

Publication types

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources

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Medical