International consensus statement on microbiome testing in clinical practice
Porcari, Serena Mullish, Benjamin H Asnicar, Francesco Ng, Siew C Zhao, Liping Hansen, Richard O'Toole, Paul W Raes, Jeroen Hold, Georgina Putignani, Lorenza
Porcari, Serena
Mullish, Benjamin H
Asnicar, Francesco
Ng, Siew C
Zhao, Liping
Hansen, Richard
O'Toole, Paul W
Raes, Jeroen
Hold, Georgina
Putignani, Lorenza
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2024-12-05
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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.
Citation
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. International consensus statement on microbiome testing in clinical practice. Lancet Gastroenterol Hepatol. 2024 Dec 5:S2468-1253(24)00311-X. doi: 10.1016/S2468-1253(24)00311-X. Epub ahead of print.
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