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 Hvas, Christian Lodberg Zeller, Georg Koren, Omry Tun, Hein Valles-Colomer, Mireia Collado, Maria Carmen Fischer, Monika Allegretti, Jessica Iqbal, Tariq Chassaing, Benoit Keller, Josbert Baunwall, Simon Mark Abreu, Maria Barbara, Giovanni Zhang, Faming Ponziani, Francesca Romana Costello, Sam P Paramsothy, Sudarshan Kao, Dina Kelly, Colleen Kupcinskas, Juozas Youngster, Ilan Franceschi, Francesco Khanna, Sahil Vehreschild, Maria Link, Alexander De Maio, Flavio Pasolli, Edoardo Miguez, Aitor Blanco Brigidi, Patrizia Posteraro, Brunella Scaldaferri, Franco Stojanovic, Mirjana Rajilic Megraud, Francis Malfertheiner, Peter Masucci, Luca Arumugam, Manimozhiyan Kaakoush, Nadeem Segal, Eran Bajaj, Jasmohan Leong, Rupert Cryan, John Weersma, Rinse K Knight, Robert Guarner, Francisco Shanahan, Fergus Cani, Patrice D. [UCL] Elinav, Eran Sanguinetti, Maurizio de Vos, Willem M El-Omar, Emad Dorè, Joel Marchesi, Julian Tilg, Herbert Sokol, Harry Segata, Nicola Cammarota, Giovanni Gasbarrini, Antonio Ianiro, Gianluca et al.[show all]

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.