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澳大利亚共识声明:临床实践中粪便微生物群移植的监管、生产和使用。

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

机构信息

The University of Sydney, Sydney, New South Wales, Australia.

St Vincent's Hospital, Sydney, New South Wales, Australia.

出版信息

Gut. 2020 May;69(5):801-810. doi: 10.1136/gutjnl-2019-320260. Epub 2020 Feb 11.


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

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

摘要

目的:粪便微生物群移植(FMT)已被证明是治疗复发性感染的一种极其有效的方法,人们对其在其他胃肠道和全身性疾病中的潜在应用产生了兴趣。然而,最近 FMT 导致的死亡和败血症事件突显了进一步评估和制定供体评估、生产标准、治疗设施和可接受临床适应证指南的必要性。

设计:对于这些共识声明,一个由 24 名多学科工作组的成员在线投票,然后亲自开会,使用改良 Delphi 方法根据最佳证据和专家意见制定和完善一系列建议。邀请参加的对象是澳大利亚的专家,国际代表协助其发展。以下是关于 FMT 在临床实践中的使用的问题:供体选择和筛查、临床适应证、FMT 中心的要求和未来方向。使用 GRADE(推荐评估、制定和评价分级)系统对证据进行评级。

结果:就 27 项声明达成了共识,为 FMT 提供了最佳实践指南。这些声明包括:(1)推荐临床选择标准、血液和粪便检测的最低供体筛查标准;(2)接受的给药途径;(3)临床适应证;(4)FMT 生产的最低标准和治疗设施的要求,承认单站点中心(例如,基于医院)和粪便库之间的区别;(5)关于未来研究和产品开发的建议。

结论:这些 FMT 共识声明提供了有关临床实践中 FMT 生产和使用的全面建议,与临床医生、研究人员和政策制定者有关。

相似文献

[1]
Australian consensus statements for the regulation, production and use of faecal microbiota transplantation in clinical practice.

Gut. 2020-2-11

[2]
International consensus conference on stool banking for faecal microbiota transplantation in clinical practice.

Gut. 2019-9-28

[3]
Swiss expert opinion: current approaches in faecal microbiota transplantation in daily practice.

Swiss Med Wkly. 2023-8-25

[4]
European consensus conference on faecal microbiota transplantation in clinical practice.

Gut. 2017-4

[5]
[Reconsidering the technical aspects and quality management background of faecal microbiota transplantation due to the novel coronavirus pandemic].

Orv Hetil. 2020-11-1

[6]
Fecal microbiota transplantation for Clostridium difficile infection in Taiwan: Establishment and implementation.

J Microbiol Immunol Infect. 2019-9-30

[7]
A comprehensive approach to stool donor screening for faecal microbiota transplantation in China.

Microb Cell Fact. 2021-11-27

[8]
Stool Banking for Fecal Microbiota Transplantation: Methods and Operations at a Large Stool Bank.

Front Cell Infect Microbiol. 2021

[9]
[Faecal microbiota transplantation for the treatment of bowel disease].

Ugeskr Laeger. 2017-7-31

[10]
Faecal microbiota transplantation for infection: Four years' experience of the Netherlands Donor Feces Bank.

United European Gastroenterol J. 2020-12

引用本文的文献

[1]
Intestinal Microbiota and Fecal Transplantation in Patients with Inflammatory Bowel Disease and : An Updated Literature Review.

J Clin Med. 2025-7-25

[2]
Radiation-induced injury and the gut microbiota: insights from a microbial perspective.

Therap Adv Gastroenterol. 2025-6-16

[3]
Prolonged effect of antibiotic therapy on the gut microbiota composition, functionality, and antibiotic resistance genes' profiles in healthy stool donors.

Front Microbiol. 2025-5-9

[4]
Fecal microbiota transplantation for hypertension: an exploratory, multicenter, randomized, blinded, placebo-controlled trial.

Microbiome. 2025-5-23

[5]
Outcomes of Fecal Microbiota Transplantation for Infection in South Australia.

Open Forum Infect Dis. 2025-3-13

[6]
Fecal microbiota transplantation for the treatment of intestinal and extra-intestinal diseases: Mechanism basis, clinical application, and potential prospect.

Bioeng Transl Med. 2024-11-7

[7]
Evaluation of effectiveness of bacteriophage purification methods.

Virol J. 2024-12-19

[8]
Clinical efficacy and safety of faecal microbiota transplantation in the treatment of irritable bowel syndrome: a systematic review, meta-analysis and trial sequential analysis.

Eur J Med Res. 2024-9-18

[9]
Microbiota treatment of functional constipation: Current status and future prospects.

World J Hepatol. 2024-5-27

[10]
Fecal microbiota transplantation: current challenges and future landscapes.

Clin Microbiol Rev. 2024-6-13

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