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.

中文翻译：

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澳大利亚关于粪便微生物群移植在临床实践中的监管、生产和使用的共识声明

目的 粪便微生物群移植 (FMT) 已被证明是治疗复发性艰难梭菌感染极其有效的方法，并且其在其他胃肠道和全身性疾病中的潜在应用受到关注。然而，最近 FMT 后发生的死亡和败血症凸显了对供体评估、生产标准、治疗设施和可接受的临床适应症进行进一步评估和指导的必要性。设计 对于这些共识声明，一个由 24 名成员组成的多学科工作组在线投票，然后亲自召集，使用修改后的 Delphi 方法根据最佳证据和专家意见制定和完善一系列建议。参与邀请是针对澳大利亚专家的，一名国际代表协助开发。解决了有关 FMT 在临床实践中使用的以下问题：供体选择和筛选、临床适应症、FMT 中心的要求和未来方向。使用 GRADE（建议评估、开发和评估分级）系统对证据进行评级。结果 就 27 项声明达成共识，为 FMT 的最佳实践提供指导。这些包括： (1) 推荐的临床选择标准、血液和粪便检测的供体筛选的最低标准；(2) 可接受的给药途径；(3)临床适应症；(4) FMT 生产的最低标准和处理设施的要求，承认单点中心（例如，基于医院的）和粪便库之间的区别；(5) 对未来研究和产品开发的建议。