Swann J R, Rajilic-Stojanovic M, Salonen A, Sakwinska O, Gill C, Meynier A, Fança-Berthon P, Schelkle B, Segata N, Shortt C, Tuohy K, Hasselwander O
Division of Integrative Systems Medicine and Digestive Diseases, Imperial College London, London, UK.
School of Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, UK.
Eur J Nutr. 2020 Dec;59(8):3347-3368. doi: 10.1007/s00394-020-02232-1. Epub 2020 Apr 3.
With the growing appreciation for the influence of the intestinal microbiota on human health, there is increasing motivation to design and refine interventions to promote favorable shifts in the microbiota and their interactions with the host. Technological advances have improved our understanding and ability to measure this indigenous population and the impact of such interventions. However, the rapid growth and evolution of the field, as well as the diversity of methods used, parameters measured and populations studied, make it difficult to interpret the significance of the findings and translate their outcomes to the wider population. This can prevent comparisons across studies and hinder the drawing of appropriate conclusions. This review outlines considerations to facilitate the design, implementation and interpretation of human gut microbiota intervention studies relating to foods based upon our current understanding of the intestinal microbiota, its functionality and interactions with the human host. This includes parameters associated with study design, eligibility criteria, statistical considerations, characterization of products and the measurement of compliance. Methodologies and markers to assess compositional and functional changes in the microbiota, following interventions are discussed in addition to approaches to assess changes in microbiota-host interactions and host responses. Last, EU legislative aspects in relation to foods and health claims are presented. While it is appreciated that the field of gastrointestinal microbiology is rapidly evolving, such guidance will assist in the design and interpretation of human gut microbiota interventional studies relating to foods.
随着人们对肠道微生物群对人类健康影响的认识不断加深，设计和完善干预措施以促进微生物群的有利转变及其与宿主的相互作用的动机也日益增强。技术进步提高了我们对这一固有群体的理解以及测量此类干预措施影响的能力。然而，该领域的快速发展和演变，以及所使用方法的多样性、测量的参数和研究的人群，使得难以解释研究结果的意义并将其成果推广到更广泛的人群。这可能会妨碍不同研究之间的比较，并阻碍得出恰当的结论。本综述概述了一些注意事项，以便根据我们目前对肠道微生物群及其功能以及与人类宿主相互作用的理解，促进与食物相关的人体肠道微生物群干预研究的设计、实施和解释。这包括与研究设计、纳入标准、统计考量、产品特性描述以及依从性测量相关的参数。除了评估微生物群与宿主相互作用及宿主反应变化的方法外，还讨论了评估干预后微生物群组成和功能变化的方法和标志物。最后，介绍了欧盟关于食品和健康声称的立法方面。尽管认识到胃肠道微生物学领域正在迅速发展，但此类指南将有助于设计和解释与食物相关的人体肠道微生物群干预研究。
