Design and reporting of prebiotic and probiotic clinical trials in the context of diet and the gut microbiome | Nature Microbiology

Nature Microbiology volume 9, pages 2785–2794 (2024)Cite this article Metrics details Diet is a major determinant of the gastrointestinal microbiome composition and function, yet our understanding of

Nature Microbiology volume 9, pages 2785–2794 (2024)Cite this article

Metrics details

Diet is a major determinant of the gastrointestinal microbiome composition and function, yet our understanding of how it impacts the efficacy of prebiotics and probiotics is limited. Here we examine current evidence of dietary influence on prebiotic and probiotic efficacy in human studies, including potential mechanisms. We propose that habitual diet be included as a variable in prebiotic and probiotic intervention studies. This recommendation is based on the potential mechanisms via which diet can affect study outcomes, either directly or through the gut microbiome. We consider the challenges and opportunities of dietary assessment in this context. Lastly, we provide recommendations for the design, conduct and reporting of human clinical trials of prebiotics and probiotics (and other biotic interventions) to account for any effect of diet and nutrition.

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This paper is based in part on an expert panel workshop undertaken at the ISAPP Annual Meeting in Sitges, Spain in June 2022. The manuscript was written by invited speakers who presented in that workshop. We thank all of the participants in this workshop for their contribution to the discussion, as well as ISAPP for providing the forum for collaboration and discussion.

Department of Nutritional Sciences, King’s College London, London, UK

Kevin Whelan

Department of Medical Microbiology and Immunology, University of Wisconsin, Madison, WI, USA

Margaret Alexander

Laboratoire d’Ingenierie des Biomolecules, Université de Lorraine, Nancy, France

Claire Gaiani

Institut Universitaire de France, Paris, France

Claire Gaiani

Department of Pediatrics, University of British Columbia, Vancouver, Canada

Genelle Lunken

School of Life and Environmental Sciences, University of Sydney, Sydney, New South Wales, Australia

Andrew Holmes

Charles Perkins Centre, University of Sydney, Sydney, New South Wales, Australia

Andrew Holmes

Food and Mood Centre, IMPACT Institute, Deakin University, Melbourne, Victoria, Australia

Heidi M. Staudacher

BENEO-Institute, Obrigheim, Germany

Stephan Theis

Department of Food Science and Technology, University of California, Davis, Davis, CA, USA

Maria L. Marco

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All authors contributed to the conception and design of the manuscript, wrote individual sections of the manuscript, critically commented on preliminary drafts and approved the final version before submission. K.W. and M.L.M. led the synthesis of sections and revisions.

Correspondence to Kevin Whelan or Maria L. Marco.

K.W. has received research grants from commercial funders, including the Almond Board of California, Danone and International Nut and Dried Fruit Council, has received speaker fees from Yakult UK and Danone and is the holder of a joint patent to use volatile organic compounds in the diagnosis and dietary management of irritable bowel syndrome (Biomarkers for irritable bowel syndrome, PCT/GB2020/051604). C.G. has received research grants from commercial funders, including Nestlé, Arla Food Ingredients, the French Dairy Interbranch Organization and the International Fine Particle Research Institute, and benefited from the support of the project GEL ANR-18-CE21-0003 of the French National Research Agency. H.M.S. has served as a speaker for the Rome Foundation, Dietitian Connection and Microba, and was a consultant for DSM Pharmaceuticals. S.T. is an employee of Südzucker/BENEO Group. M.L.M. is on the NURA scientific advisory board, ISAPP Board of Directors and Institute for the Advancement of Food and Nutrition Sciences subcommittee on live microorganisms. The other authors declare no competing interests.

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Whelan, K., Alexander, M., Gaiani, C. et al. Design and reporting of prebiotic and probiotic clinical trials in the context of diet and the gut microbiome. Nat Microbiol 9, 2785–2794 (2024). https://doi.org/10.1038/s41564-024-01831-6

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Received: 19 November 2023

Accepted: 12 September 2024

Published: 30 October 2024

Issue Date: November 2024

DOI: https://doi.org/10.1038/s41564-024-01831-6

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Design and reporting of prebiotic and probiotic clinical trials in the context of diet and the gut microbiome | Nature Microbiology