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

Identifieur interne : 000271 ( Main/Corpus ); précédent : 000270; suivant : 000272

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

Auteurs : Craig Haifer ; Colleen R. Kelly ; Sudarshan Paramsothy ; David Andresen ; Lito E. Papanicolas ; Genevieve L. Mckew ; Thomas J. Borody ; Michael Kamm ; Samuel P. Costello ; Jane M. Andrews ; Jakob Begun ; Hiu Tat Chan ; Susan Connor ; Simon Ghaly ; Paul Dr Johnson ; Daniel A. Lemberg ; Ramesh Paramsothy ; Andrew Redmond ; Harsha Sheorey ; David Van Der Poorten ; Rupert W. Leong

Source :

RBID : pubmed:32047093

English descriptors

Abstract

OBJECTIVE

Faecal microbiota transplantation (FMT) has proved to be an extremely effective treatment for recurrent

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.


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

Links to Exploration step

pubmed:32047093

Le document en format XML

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<name sortKey="Chan, Hiu Tat" sort="Chan, Hiu Tat" uniqKey="Chan H" first="Hiu Tat" last="Chan">Hiu Tat Chan</name>
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</affiliation>
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<name sortKey="Connor, Susan" sort="Connor, Susan" uniqKey="Connor S" first="Susan" last="Connor">Susan Connor</name>
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<affiliation>
<nlm:affiliation>University of New South Wales, Sydney, New South Wales, Australia.</nlm:affiliation>
</affiliation>
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<name sortKey="Ghaly, Simon" sort="Ghaly, Simon" uniqKey="Ghaly S" first="Simon" last="Ghaly">Simon Ghaly</name>
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<affiliation>
<nlm:affiliation>University of New South Wales, Sydney, New South Wales, Australia.</nlm:affiliation>
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<name sortKey="Johnson, Paul Dr" sort="Johnson, Paul Dr" uniqKey="Johnson P" first="Paul Dr" last="Johnson">Paul Dr Johnson</name>
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</affiliation>
<affiliation>
<nlm:affiliation>Austin Hospital, Melbourne, Victoria, Australia.</nlm:affiliation>
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</affiliation>
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<nlm:affiliation>Blacktown Hospital, Sydney, New South Wales, Australia.</nlm:affiliation>
</affiliation>
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<name sortKey="Redmond, Andrew" sort="Redmond, Andrew" uniqKey="Redmond A" first="Andrew" last="Redmond">Andrew Redmond</name>
<affiliation>
<nlm:affiliation>The University of Queensland, Brisbane, Queensland, Australia.</nlm:affiliation>
</affiliation>
<affiliation>
<nlm:affiliation>Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia.</nlm:affiliation>
</affiliation>
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<nlm:affiliation>St Vincent's Hospital, Melbourne, Victoria, Australia.</nlm:affiliation>
</affiliation>
</author>
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<name sortKey="Van Der Poorten, David" sort="Van Der Poorten, David" uniqKey="Van Der Poorten D" first="David" last="Van Der Poorten">David Van Der Poorten</name>
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<nlm:affiliation>The University of Sydney, Sydney, New South Wales, Australia.</nlm:affiliation>
</affiliation>
<affiliation>
<nlm:affiliation>Westmead Hospital, Sydney, New South Wales, Australia.</nlm:affiliation>
</affiliation>
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<nlm:affiliation>The University of Sydney, Sydney, New South Wales, Australia rupertleong@outlook.com.</nlm:affiliation>
</affiliation>
<affiliation>
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<term>Clostridium Infections (therapy)</term>
<term>Consensus (MeSH)</term>
<term>Donor Selection (MeSH)</term>
<term>Fecal Microbiota Transplantation (methods)</term>
<term>Female (MeSH)</term>
<term>Health Facilities (statistics & numerical data)</term>
<term>Humans (MeSH)</term>
<term>Male (MeSH)</term>
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<div type="abstract" xml:lang="en">
<p>
<b>OBJECTIVE</b>
</p>
<p>Faecal microbiota transplantation (FMT) has proved to be an extremely effective treatment for recurrent </p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>DESIGN</b>
</p>
<p>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.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>RESULTS</b>
</p>
<p>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.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>CONCLUSIONS</b>
</p>
<p>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.</p>
</div>
</front>
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<Month>11</Month>
<Day>03</Day>
</DateCompleted>
<DateRevised>
<Year>2020</Year>
<Month>11</Month>
<Day>03</Day>
</DateRevised>
<Article PubModel="Print-Electronic">
<Journal>
<ISSN IssnType="Electronic">1468-3288</ISSN>
<JournalIssue CitedMedium="Internet">
<Volume>69</Volume>
<Issue>5</Issue>
<PubDate>
<Year>2020</Year>
<Month>05</Month>
</PubDate>
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<Title>Gut</Title>
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<ArticleTitle>Australian consensus statements for the regulation, production and use of faecal microbiota transplantation in clinical practice.</ArticleTitle>
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<ELocationID EIdType="doi" ValidYN="Y">10.1136/gutjnl-2019-320260</ELocationID>
<Abstract>
<AbstractText Label="OBJECTIVE">Faecal microbiota transplantation (FMT) has proved to be an extremely effective treatment for recurrent
<i>Clostridioides difficile</i>
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.</AbstractText>
<AbstractText Label="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.</AbstractText>
<AbstractText Label="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.</AbstractText>
<AbstractText Label="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.</AbstractText>
<CopyrightInformation>© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.</CopyrightInformation>
</Abstract>
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<LastName>Haifer</LastName>
<ForeName>Craig</ForeName>
<Initials>C</Initials>
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<AffiliationInfo>
<Affiliation>The University of Sydney, Sydney, New South Wales, Australia.</Affiliation>
</AffiliationInfo>
<AffiliationInfo>
<Affiliation>St Vincent's Hospital, Sydney, New South Wales, Australia.</Affiliation>
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<CoiStatement>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.</CoiStatement>
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