Australian consensus statements for the regulation, production and use of faecal microbiota transplantation in clinical practice

Craig Haifer^{1

2}, Colleen R Kelly³, Sudarshan Paramsothy^{1

4}, David Andresen^{1

2}, Lito E Papanicolas^{5

6}, Genevieve L McKew^{1

4}, Thomas J Borody⁷, Michael Kamm^{8

9}, Samuel P Costello^{10

11}, Jane M Andrews^{6

12}, Jakob Begun^{13

14}, Hiu Tat Chan¹⁵, Susan Connor^{16

17}, Simon Ghaly^{2

17}, Paul Dr Johnson^{9

18}, Daniel A Lemberg^{17

19}, Ramesh Paramsothy²⁰, Andrew Redmond^{13

21}, Harsha Sheorey⁸, David van der Poorten^{1

22}, Rupert W Leong^{23

4}

Affiliations

¹ The University of Sydney, Sydney, New South Wales, Australia.
² St Vincent's Hospital, Sydney, New South Wales, Australia.
³ Warren Alpert Medical School, Brown University, Providence, Rhode Island, USA.
⁴ Concord Repatriation General Hospital, Sydney, New South Wales, Australia.
⁵ South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia.
⁶ Royal Adelaide Hospital, Adelaide, South Australia, Australia.
⁷ Centre for Digestive Diseases, Sydney, New South Wales, Australia.
⁸ St Vincent's Hospital, Melbourne, Victoria, Australia.
⁹ The University of Melbourne, Melbourne, Victoria, Australia.
¹⁰ The Queen Elizabeth Hospital, Woodville, South Australia, Australia.
¹¹ BiomeBank, Adelaide, South Australia, Australia.
¹² The University of Adelaide, Adelaide, South Australia, Australia.
¹³ The University of Queensland, Brisbane, Queensland, Australia.
¹⁴ Mater Hospital Brisbane, Brisbane, Queensland, Australia.
¹⁵ VCS Pathology, Melbourne, Victoria, Australia.
¹⁶ Liverpool Hospital, Sydney, New South Wales, Australia.
¹⁷ University of New South Wales, Sydney, New South Wales, Australia.
¹⁸ Austin Hospital, Melbourne, Victoria, Australia.
¹⁹ Sydney Children's Hospital Randwick, Randwick, New South Wales, Australia.
²⁰ Blacktown Hospital, Sydney, New South Wales, Australia.
²¹ Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia.
²² Westmead Hospital, Sydney, New South Wales, Australia.
²³ The University of Sydney, Sydney, New South Wales, Australia rupertleong@outlook.com.

PMID: 32047093
DOI: 10.1136/gutjnl-2019-320260

Review

Australian consensus statements for the regulation, production and use of faecal microbiota transplantation in clinical practice

Craig Haifer et al. Gut. 2020 May.

. 2020 May;69(5):801-810.

doi: 10.1136/gutjnl-2019-320260. Epub 2020 Feb 11.

Authors

Affiliations

¹ The University of Sydney, Sydney, New South Wales, Australia.
² St Vincent's Hospital, Sydney, New South Wales, Australia.
³ Warren Alpert Medical School, Brown University, Providence, Rhode Island, USA.
⁴ Concord Repatriation General Hospital, Sydney, New South Wales, Australia.
⁵ South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia.
⁶ Royal Adelaide Hospital, Adelaide, South Australia, Australia.
⁷ Centre for Digestive Diseases, Sydney, New South Wales, Australia.
⁸ St Vincent's Hospital, Melbourne, Victoria, Australia.
⁹ The University of Melbourne, Melbourne, Victoria, Australia.
¹⁰ The Queen Elizabeth Hospital, Woodville, South Australia, Australia.
¹¹ BiomeBank, Adelaide, South Australia, Australia.
¹² The University of Adelaide, Adelaide, South Australia, Australia.
¹³ The University of Queensland, Brisbane, Queensland, Australia.
¹⁴ Mater Hospital Brisbane, Brisbane, Queensland, Australia.
¹⁵ VCS Pathology, Melbourne, Victoria, Australia.
¹⁶ Liverpool Hospital, Sydney, New South Wales, Australia.
¹⁷ University of New South Wales, Sydney, New South Wales, Australia.
¹⁸ Austin Hospital, Melbourne, Victoria, Australia.
¹⁹ Sydney Children's Hospital Randwick, Randwick, New South Wales, Australia.
²⁰ Blacktown Hospital, Sydney, New South Wales, Australia.
²¹ Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia.
²² Westmead Hospital, Sydney, New South Wales, Australia.
²³ The University of Sydney, Sydney, New South Wales, Australia rupertleong@outlook.com.

PMID: 32047093
DOI: 10.1136/gutjnl-2019-320260

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.

Keywords: Clostridioides difficile; FMT; faecal microbiota transplantation; inflammatory bowel disease; microbiome therapeutics; stool bank.

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Conflict of interest statement

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.

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Australian consensus statements for the regulation, production and use of faecal microbiota transplantation in clinical practice

Affiliations

Australian consensus statements for the regulation, production and use of faecal microbiota transplantation in clinical practice

Authors

Affiliations

Abstract

Conflict of interest statement

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