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International consensus conference on stool banking for faecal microbiota transplantation in clinical practice
  1. Giovanni Cammarota1,
  2. Gianluca Ianiro2,
  3. Colleen R Kelly3,
  4. Benjamin H Mullish4,
  5. Jessica R Allegretti5,
  6. Zain Kassam6,7,
  7. Lorenza Putignani8,
  8. Monika Fischer9,
  9. Josbert J Keller10,11,
  10. Samuel Paul Costello12,
  11. Harry Sokol13,14,15,
  12. Patrizia Kump16,
  13. Reetta Satokari17,
  14. Stacy A Kahn18,
  15. Dina Kao19,
  16. Perttu Arkkila20,
  17. Ed J Kuijper21,
  18. Maria J GT Vehreschild22,
  19. Cristina Pintus23,
  20. Loris Lopetuso24,
  21. Luca Masucci25,
  22. Franco Scaldaferri24,
  23. E M Terveer11,21,
  24. Max Nieuwdorp26,
  25. Antonio López-Sanromán27,
  26. Juozas Kupcinskas28,
  27. Ailsa Hart29,
  28. Herbert Tilg30,
  29. Antonio Gasbarrini31
  1. 1 Internal Medicine and Gastroenterology, Day Hospital of Gastroenterology and Intestinal Microbiota Transplantation, Fondazione Policlinico A Gemelli IRCCS, Catholic University of Medicine, Roma, Italy
  2. 2 Internal Medicine and Gastroenterology, Day Hospital of Gastroenterology and Intestinal Microbiota Transplantation, Fondazione Policlinico A Gemelli IRCCS, Roma, Italy
  3. 3 Division of Gastroenterology, Alpert Medical School of Brown University, Providence, Rhode Island, United States of America
  4. 4 Department of Metabolism, Digestion and Reproduction, Faculty of Medicine, Imperial College London, London, United Kingdom
  5. 5 Division of Gastroenterology, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts, United States of America
  6. 6 Microbiome Informatics, Massachusetts Institute of Technology, Cambridge, Massachusetts, United States of America
  7. 7 OpenBiome, Somerville, Massachusetts, United States of America
  8. 8 Parasitology Unit and Human Microbiome Unit, Bambino Gesù Pediatric Hospital, Roma, Italy
  9. 9 Department of Medicine, Indiana University, Indianapolis, Indiana, United States of America
  10. 10 Department of Gastroenterologyand Hepatology, Haaglanden Medical Center, 2597 AX, The Hague, Netherlands
  11. 11 National Donor Feces Bank, LUMC, Leiden, the Netherlands
  12. 12 Department of Gastroenterology, The Queen Elizabeth Hospital, University of Adelaide, Woodville, South Australia, Australia
  13. 13 Service de Gastroenterologie, Hôpital Saint Antoine, Sorbonne Université, Inserm, Centre de Recherche Saint-Antoine, Paris, France
  14. 14 French Group of Fecal Microbiota Transplantation, Paris, France
  15. 15 INRA, UMR1319 Micalis, AgroParisTech, Jouy-en-Josas, France
  16. 16 Division of Gastroenterology and Hepatology, Department of Internal Medicine, Medical University of Graz, Graz, Austria
  17. 17 Human Microbiome Research Program, Faculty of Medicine, University of Helsinki, Helsinki, Finland
  18. 18 Division of Gastroenterology, Hepatology and Nutrition, Boston Children's Hospital, Boston, Massachusetts, Uunited States of America
  19. 19 Division of Gastroenterology, Department of Medicine, University of Alberta, Edmonton, Alberta, Canada
  20. 20 Department of Clinic of Gastroenterology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland
  21. 21 Department of Medical Microbiology, Leiden University Medical Centre, Leiden, the Netherlands
  22. 22 Department I of Internal Medicine; German Centre for Infection Research, Partner site Bonn-Cologne, University Hospital of Cologne, Cologne, Germany
  23. 23 Tissues and Cells Area, Italian National Transplant Center, Rome, Italy
  24. 24 Internal Medicine and Gastroenterology, Fondazione Policlinico A Gemelli IRCCS, Roma, Italy
  25. 25 Microbiology, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Catholic University of Medicine, Roma, Italy
  26. 26 Department of Internal Medicine, Amsterdam University Medical Centers, location AMC and VuMC, Amsterdam, Netherlands
  27. 27 Gastroenterology and Hepatology Department, Hospital Universitario Ramon y Cajal, Madrid, Spain
  28. 28 Department of Gastroenterology, Institute for Digestive Research, Medical Academy, Lithuanian University of Health Sciences, Kaunas, Lithuania
  29. 29 Department of Gastroenterology, St Mark's Hospital, London, United Kingdom
  30. 30 Department of Internal Medicine I, Gastroenterology, Endocrinology & Metabolism, Innsbruck Medical University, Innsbruck, Austria
  31. 31 Internal Medicine and Gastroenterology, Fondazione Policlinico A Gemelli IRCCS, Catholic University of Medicine, Roma, Italy
  1. Correspondence to Professor Giovanni Cammarota, Internal Medicine and Gastroenterology, Fondazione Policlinico A Gemelli IRCCS, Roma 00168, Italy; giovanni.cammarota{at}unicatt.it

Abstract

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
  • guideline
  • microbiota
  • stool bank

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Footnotes

  • 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.

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