There is growing interest in the potential exploitation of the gut microbiome as a diagnostic tool in medicine, but evidence supporting its clinical usefulness is scarce. An increasing number of commercial providers offer direct-to-consumer microbiome diagnostic tests without any consensus on their regulation or any proven value in clinical practice, which could result in considerable waste of individual and health-care resources and potential drawbacks in the clinical management of patients. We convened an international multidisciplinary expert panel to standardise best practices of microbiome testing for clinical implementation, including recommendations on general principles and minimum requirements for their provision, indications, pre-testing protocols, method of analyses, reporting of results, and potential clinical value. We also evaluated current knowledge gaps and future directions in this field. We aimed to establish a framework to regulate the provision of microbiome testing and minimise the use of inappropriate tests and pave the way for the evidence-based development and use of human microbiome diagnostics in clinical medicine.

中文翻译：

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关于临床实践中微生物组检测的国际共识声明


人们对肠道微生物组作为医学诊断工具的潜在开发越来越感兴趣，但支持其临床实用性的证据很少。越来越多的商业提供商提供直接面向消费者的微生物组诊断测试，而对其监管没有任何共识，也没有在临床实践中证明任何价值，这可能会导致个人和医疗保健资源的大量浪费，并在患者的临床管理中产生潜在缺陷。我们召集了一个国际多学科专家小组，以标准化用于临床实施的微生物组检测的最佳实践，包括关于其提供的一般原则和最低要求、适应症、检测前方案、分析方法、结果报告和潜在临床价值的建议。我们还评估了该领域当前的知识差距和未来方向。我们旨在建立一个框架来规范微生物组检测的提供，最大限度地减少不适当测试的使用，并为临床医学中人类微生物组诊断的循证开发和使用铺平道路。