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Australian consensus statements for the regulation, production and use of faecal microbiota transplantation in clinical practice
  1. Craig Haifer1,2,
  2. Colleen R Kelly3,
  3. Sudarshan Paramsothy1,4,
  4. David Andresen1,2,
  5. Lito E Papanicolas5,6,
  6. Genevieve L McKew1,4,
  7. Thomas J Borody7,
  8. Michael Kamm8,9,
  9. Samuel P Costello10,11,
  10. Jane M Andrews6,12,
  11. Jakob Begun13,14,
  12. Hiu Tat Chan15,
  13. Susan Connor16,17,
  14. Simon Ghaly2,17,
  15. Paul DR Johnson9,18,
  16. Daniel A Lemberg17,19,
  17. Ramesh Paramsothy20,
  18. Andrew Redmond13,21,
  19. Harsha Sheorey8,
  20. David van der Poorten1,22,
  21. Rupert W Leong1,4
  1. 1The University of Sydney, Sydney, New South Wales, Australia
  2. 2St Vincent's Hospital, Sydney, New South Wales, Australia
  3. 3Warren Alpert Medical School, Brown University, Providence, Rhode Island, USA
  4. 4Concord Repatriation General Hospital, Sydney, New South Wales, Australia
  5. 5South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia
  6. 6Royal Adelaide Hospital, Adelaide, South Australia, Australia
  7. 7Centre for Digestive Diseases, Sydney, New South Wales, Australia
  8. 8St Vincent's Hospital, Melbourne, Victoria, Australia
  9. 9The University of Melbourne, Melbourne, Victoria, Australia
  10. 10The Queen Elizabeth Hospital, Woodville, South Australia, Australia
  11. 11BiomeBank, Adelaide, South Australia, Australia
  12. 12The University of Adelaide, Adelaide, South Australia, Australia
  13. 13The University of Queensland, Brisbane, Queensland, Australia
  14. 14Mater Hospital Brisbane, Brisbane, Queensland, Australia
  15. 15VCS Pathology, Melbourne, Victoria, Australia
  16. 16Liverpool Hospital, Sydney, New South Wales, Australia
  17. 17University of New South Wales, Sydney, New South Wales, Australia
  18. 18Austin Hospital, Melbourne, Victoria, Australia
  19. 19Sydney Children's Hospital Randwick, Randwick, New South Wales, Australia
  20. 20Blacktown Hospital, Sydney, New South Wales, Australia
  21. 21Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia
  22. 22Westmead Hospital, Sydney, New South Wales, Australia
  1. Correspondence to Professor Rupert W Leong, Concord Repatriation General Hospital, Sydney, NSW 2139, Australia; rupertleong{at}outlook.com

Abstract

Objective Faecal microbiota transplantation (FMT) has proved to be an extremely effective treatment for recurrent Clostridioides difficile infection, and there is interest in its potential application in other gastrointestinal and systemic diseases. However, the recent death and episode of septicaemia following FMT highlights the need for further appraisal and guidelines on donor evaluation, production standards, treatment facilities and acceptable clinical indications.

Design For these consensus statements, a 24-member multidisciplinary working group voted online and then convened in-person, using a modified Delphi approach to formulate and refine a series of recommendations based on best evidence and expert opinion. Invitations to participate were directed to Australian experts, with an international delegate assisting the development. The following issues regarding the use of FMT in clinical practice were addressed: donor selection and screening, clinical indications, requirements of FMT centres and future directions. Evidence was rated using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system.

Results Consensus was reached on 27 statements to provide guidance on best practice in FMT. These include: (1) minimum standards for donor screening with recommended clinical selection criteria, blood and stool testing; (2) accepted routes of administration; (3) clinical indications; (4) minimum standards for FMT production and requirements for treatment facilities acknowledging distinction between single-site centres (eg, hospital-based) and stool banks; and (5) recommendations on future research and product development.

Conclusions These FMT consensus statements provide comprehensive recommendations around the production and use of FMT in clinical practice with relevance to clinicians, researchers and policy makers.

  • faecal microbiota transplantation
  • FMT
  • Clostridioides difficile
  • inflammatory bowel disease
  • microbiome therapeutics
  • stool bank
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Footnotes

  • Contributors CH, SP, DA and RWL were members of the steering committee which formulated the initial statements, completed the literature review, refined statements between each round of voting and allocated statements to delegates. All authors voted on statements and were responsible for reviewing and presenting the literature surrounding their designated statement. CH, CRK, SP, DA, LEP, HS and RWL were part of the manuscript committee which formulated the final manuscript. All authors reviewed the manuscript and approved the final version.

  • Funding This study was conducted using internal research funds through the University of Sydney.

  • Competing interests CRK has received research support and is a site investigator for Finch Therapeutics; and is a clinical advisory board member for Openbiome. SP is a consultant for Finch Therapeutics and received speaker fees from Ferring, Janssen. TJB has interest in Redhill Biopharma, Salix and Finch Therapeutics, ResMed and GSK; has interest in the Centre for Digestive Diseases, where faecal microbiota transplantation is a treatment option for patients, and has patents in this field. MK has received speaker fees, research funding, educational support or honoraria for advisory board participation from Ferring, AbbVie, Janssen, Takeda and received research support from AbbVie. SPC has received speaker fees from Shire, Ferring, Microbiotica, Pfizer and Janssen; and is a shareholder in BiomeBank. JMA has received speaker fees, research funding, educational support or honoraria for advisory board participation from Abbott, AbbVie, Allergan, Anatara, AstraZeneca, Bayer, Celegene, Ferring, Gilead, Hospira, Immuninc, ImmunsanT, Janssen, MSD, Nestle, Progenity, Pfizer, Shire, Takeda, Vifor, Royal Adelaide Research Fund and The Hospital Research Fund. JB has received speaker fees, research funding, educational support or honoraria for advisory board participation from Janssen, Takeda, AbbVie, Celgene, Ferring, Pfizer, Anatara, Microba, Shire and Progenity. SC has received speaker fees, research funding, educational support or honoraria for advisory board participation from AbbVie, Aspen/Orphan, Celgene, Ferring, Gilead, Janssen, MSD, Pfizer, Shire, Takeda and Vifor. SG has received speaker fees, research funding, educational support or honoraria for advisory board participation from Janssen Cilag, Shire, Takeda, Ferring and Pfizer and AbbVie. DAL has received speaker fees, research funding, educational support or honoraria for advisory board participation from Nutricia, Nestle, Janssen, AbbVie. RP has received speaker fees or research support from Janssen, Aspen, Pfizer, Abbvie and Takeda. RWL reports advisory board fees from AbbVie, Aspen, Celgene, Ferring, Gilead, Hospira, Janssen, MSD, Novartis, Pfizer, and Takeda; research fees from Gastrointestinal Society of Australia (GESA), Endochoice, Janssen, National Health and Medical Research Council of Australia, Shire, and Takeda; and speaker fees from Emerge Health, Ferring, Janssen, Shire, and Takeda.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement There are no data in this work

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