State of the art and the future of microbiome-based biomarkers: a multidisciplinary Delphi consensus.

Federica Carraturo, Julie Rodriguez, Robert Schierwagen, Joel Doré, Amira Metwaly, Fay Betsou, Jonel Trebicka, Mads Israelsen, Aleksander Krag, Alessio Fasano, Zahra Hassani, Carolina Alves Costa Silva, Anandhi Iyappan, Hub Zwart, Magali Cordaillat-Simmons, Celine Druart

Journal: The Lancet. Microbe 2025;6(2):100948

PMID: 39243797

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Abstract

Although microbiome signatures have been identified in various contexts (ie, pathogenesis of non-communicable diseases and treatment response), qualified microbiome-based biomarkers are currently not in use in clinical practice. The Human Microbiome Action consortium initiated a Delphi survey to establish a consensus on the needs, challenges, and limitations in developing qualified microbiome-based biomarkers. The questionnaire was developed by a scientific committee via literature review and expert interviews. To ensure broad applicability of the results, 307 experts were invited to participate; 114 of them responded to the first round of the survey, 93 of whom completed the second and final round as well. The survey highlighted the experts' confidence in the potential of microbiome-based biomarkers for several indications or pathologies. The paucity of validated analytical methods appears to be the principal factor hindering the qualification of these biomarkers. The survey also showed that clinical implementation of these biomarkers would only be possible if kitted and validated molecular assays with simple interpretation are developed. This initiative serves as a foundation for designing and implementing public-private collaborative projects to overcome the challenges and promote clinical application of microbiome-based biomarkers.

Address: Pharmabiotic Research Institute, Narbonne, France.; KPL-Paris, Paris, France.; Gustave Roussy Cancer Campus (GRCC), ClinicObiome, Villejuif Cedex, France.; CRBIP, Institut Pasteur, Université Paris-Cité, Paris, France.; European Biomedical Research Institute of Salerno (EBRIS), Salerno, Italy; Department of Biology, University of Naples Federico II, Naples, Italy.; European Biomedical Research Institute of Salerno (EBRIS), Salerno, Italy; Department of Pediatrics, Mucosal Immunology and Biology Research Center, Mass General Brigham, Harvard Medical School, Boston, MA, USA.; Centre for Liver Research, Department of Gastroenterology and Hepatology, Odense University Hospital, Odense, Denmark.; European Molecular Biology Laboratory (EMBL), Heidelberg, Germany.; Centre for Liver Research, Department of Gastroenterology and Hepatology, Odense University Hospital, Odense, Denmark; Institute of Clinical Research, University of Southern Denmark, Odense, Denmark.; Chair of Nutrition and Immunology, School of Life Sciences, Technical University of Munich, Freising, Germany.; European Foundation for the Study of Chronic Liver Failure (EF CLIF), Barcelona, Spain; Department of Internal Medicine B, University of Münster, Münster, Germany.; Erasmus School of Philosophy, Erasmus University Rotterdam, Rotterdam, Netherlands.; Université Paris-Saclay, INRAE, MGP Metagenopolis, Jouy-en-Josas, France; Université Paris-Saclay, INRAE, AgroParisTech, Micalis Institute, Jouy-en-Josas, France.; Pharmabiotic Research Institute, Narbonne, France. Electronic address: [email protected].

DOI: 10.1016/j.lanmic.2024.07.011

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MeSH Terms: Humans, Biomarkers, Delphi Technique, Microbiota, Consensus, Surveys and Questionnaires