International consensus statement on microbiome testing in clinical practice

Porcari S, Mullish BH, Asnicar F, Ng SC, Zhao L, Hansen R, O'Toole PW, Raes J, Hold G, Putignani L, Hvas CL, Zeller G, Koren O, Tun H, Valles-Colomer M, Collado MC, Fischer M, Allegretti J, Iqbal T, Chassaing B, Keller J, Baunwall SM, Abreu M, Barbara G, Zhang F, Ponziani FR, Costello SP, Paramsothy S, Kao D, Kelly C, Kupcinskas J, Youngster I, Franceschi F, Khanna S, Vehreschild M, Link A, De Maio F, Pasolli E, Miguez AB, Brigidi P, Posteraro B, Scaldaferri F, Stojanovic MR, Megraud F, Malfertheiner P, Masucci L, Arumugam M, Kaakoush N, Segal E, Bajaj J, Leong R, Cryan J, Weersma RK, Knight R, Guarner F, Shanahan F, Cani PD, Elinav E, Sanguinetti M, de Vos WM, El-Omar E, Dorè J, Marchesi J, Tilg H, Sokol H, Segata N, Cammarota G, Gasbarrini A, Ianiro G (2025)

Publication Type: Journal article, Review article

Publication year: 2025

Journal

Book Volume: 10

Pages Range: 154-167

Journal Issue: 2

DOI: 10.1016/S2468-1253(24)00311-X

Abstract

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.

Involved external institutions

University of Dundee United Kingdom (GB) University College Cork (UCC) Ireland (IE) Katholieke Universiteit Leuven (KUL) / Catholic University of Leuven Belgium (BE) University of New South Wales (UNSW) Australia (AU) Ospedale Pediatrico Bambino Gesu Italy (IT) Università degli Studi di Trento Italy (IT) Aarhus University Hospital / Aarhus Universitetshospital Denmark (DK) Leiden University Medical Center Netherlands (NL) Instituto de Agroquímica y Tecnología de Alimentos (IATA) Spain (ES) Indiana University – Purdue University Indianapolis United States (USA) (US) Brigham and Women's Hospital (BWH) United States (USA) (US) Bar-Ilan University Israel (IL) The Chinese University of Hong Kong (CUHK) China (CN) Catholic University of the Sacred Heart / Università Cattolica del Sacro Cuore Italy (IT) University Hospitals Birmingham NHS Foundation Trust United Kingdom (GB) Université Sorbonne Paris Cité France (FR) University of Belgrade / Универзитет у Београду Serbia (RS) Université de Bordeaux France (FR) Universitätsklinikum Frankfurt am Main (KGU) Germany (DE) Otto-von-Guericke-Universität Magdeburg Germany (DE) Fondazione Policlinico Universitario Agostino Gemelli IRCCS Italy (IT) Università degli Studi di Napoli Federico II Italy (IT) University of Bologna / Università di Bologna Italy (IT) Université Paris-Saclay France (FR) Imperial College London / The Imperial College of Science, Technology and Medicine United Kingdom (GB) Medizinische Universität Innsbruck Austria (AT) Microbiota I-Center (MagIC) Hong Kong (HK) Rutgers, The State University of New Jersey United States (USA) (US) University of Miami United States (USA) (US) Novo Nordisk Foundation / Novo Nordisk Fonden (NNF) Denmark (DK) Second Affiliated Hospital of Nanjing Medical University / Children's Hospital of Nanjing Medical University China (CN) The Queen Elizabeth Hospital Australia (AU) Weizmann Institute of Science Israel (IL) Virginia Commonwealth University (VCU) United States (USA) (US) Concord Repatriation General Hospital Australia (AU) University of Alberta Canada (CA) Mayo Clinic United States (USA) (US) Université Catholique de Louvain (UCL) Belgium (BE) Wageningen University & Research Netherlands (NL) Hospital Quirón Teknon / Centro Medico Teknon Spain (ES) Lithuanian University of Health Sciences / Lietuvos sveikatos mokslų universitetas (LSMU) Lithuania (LT) University Medical Center Groningen (UMCG) / Universitair Medisch Centrum Groningen Netherlands (NL) Tel Aviv University Israel (IL)

How to cite

APA:

Porcari, S., Mullish, B.H., Asnicar, F., Ng, S.C., Zhao, L., Hansen, R.,... Ianiro, G. (2025). International consensus statement on microbiome testing in clinical practice. Lancet Gastroenterology and Hepatology, 10(2), 154-167. https://doi.org/10.1016/S2468-1253(24)00311-X

MLA:

Porcari, Serena, et al. "International consensus statement on microbiome testing in clinical practice." Lancet Gastroenterology and Hepatology 10.2 (2025): 154-167.

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