International consensus statement on microbiome testing in clinical practice.

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.
Competing Interests: Declaration of interests JA received research support from Pfizer, Janssen, and Merck; has been a speaker for BMS, AbbVie, and Janssen; and reports consultancy with Janssen, Pfizer, AbbVie, Seres Therapeutics, Ferring, GSK, Merck, Bristol Myer Squibb Roivant, and Adiso. JB received grants to institution from Bausch, Grifols, Mallinckrodt, Cosmo, and Sequana and received personal fees for acting as has consultant for Merz and Novo Nordisk. PDC was co-founder of The Akkermansia Company and Enterosys. WMdV was co-founder and shareholder of The Akkermansia Company (Belgium), Caelus Pharmaceuticals (Netherlands) and Alba Health (Copenhagen-Stockholm). EE is a scientific cofounder of DayTwo and BiomX and is an advisor to Purposebio, Aposense, Zoe, and MyGutly. FG has received personal fees for acting as speaker and consultant from Biocodex, Danone, BioGaia, Menarini, and Sanofi. CLH received lecture honoraria from Baxter, Janssen, BMS, and Tillotts. SK received research support from Rebioitx/Ferring, Vedanta, Finch, Seres, and Pfizer and served as consultant for ProbioTech, Takeda, and Rise. OK is a co-founder of Shela Accurate Diagnosis (Israel). JKu received travel support and speaker fees from Ferring, AbbVie, KRKA, Takeda, Janssen, Pfizer, and Ipsen. RL received research funding from Celltrion, Shire, Janssen, Takeda, Gastroenterological Society of Australia, NHMRC, Gutsy Group, Pfizer, Joanna Tiddy grant, and McKusker Charitable Foundation and is an advisory board member for AbbVie, Aspen, BMS, Celgene, Celltrion, Chiesi, Ferring, Glutagen, Hospira, Janssen, Lilly, MSD, Novartis, Pfizer, Prometheus Biosciences, and Takeda. PM received speaker honoraria from Aboca, Alfasigma, Allergosan, Bayer, Biocodex, and Menarini and is a member of the advisory board of Aboca, Alfasigma, Allergosan, Bayer, Biocodex, and Menarini. JM has received consultancy fees from Cultech and EnterioBioti. SCN received personal fees for acting as speaker for Ferring, Tillotts, Menarini, Janssen, AbbVie, and Takeda; receives patent royalties through her affiliated institutions and is named inventors of patent applications held by The Chinese University of Hong Kong and Microbiota I-Center that cover the therapeutic and diagnostic use of microbiome; received research grants through her affiliated institutions from Olympus, Ferring, and AbbVie; is a founder member and shareholder of GenieBiome; and has served as an advisory board member for Pfizer, Ferring, Janssen, and AbbVie. SPa reports consultancy for Vedanta Biosciences and received personal fees for acting as speaker and for acting as advisory board member for AbbVie, Dr Falk Pharma, Ferring, Janssen, and Takeda. FRP received personal fees for acting as speaker or consultant for AbbVie, Gilead, Roche, Astra Zeneca, Ipsen MSD, Eisai, Kedrion, Bayer, and Alfasigma and is an advisory board member of AbbVie, Gilead, Roche, Astra Zeneca, Ipsen MSD, Eisai, Kedrion, Bayer, and Alfasigma. MRS received personal fees for acting as speaker or advisory board member for Hemofarm, Abela Pharm, and ADOC Pharma. HS reports lecture fee, board membership, or consultancy from Amgen, Fresenius, Ipsen, Actial, Astellas, Danone, THAC, Biose, BiomX, Eligo, Immusmol, Adare, Nestle, Ferring, MSD, Bledina, Pfizer, Biocodex, BMS, Bromatech, Gilead, Janssen, Mayoli, Roche, Sanofi, Servier, Takeda, and AbbVie; has stocks from Enterome bioscience; and is co-founder of Exeliom Biosciences. HTu is a named inventor of patent applications held by the CUHK and MagIC that cover the therapeutic and diagnostic use of microbiome. RKW received unrestricted research grants from Takeda, Johnson & Johnson, Tramedico, and Ferring; received speaker's fees from MSD, AbbVie, and Janssen Pharmaceuticals; and acted as consultant for Takeda Pharmaceuticals. GZ is named inventor on a patent (EP2955232A1) and received personal fee as member of the scientific advisory board of Alpha Biomics. FZ conceived the concept of GenFMTer and trasnendoscopic enteral tubing and the devices related to them (FMT Medical) and is an advisory board participant for Ferring and Seres. NS reports consultancy or SAB contracts with Zoe, Roche, Ysopia, and Freya, and Alia Therapeutics; speaker fees by Illumina; and is cofounder of PreBiomics. AG reports personal fees for consultancy for Eisai, 3PSolutions, Real Time Meeting, Fondazione Istituto Danone, Sinergie Board MRGE, and Sanofi; personal fees for acting as a speaker for Takeda, AbbVie, and Sandoz; and personal fees for acting on advisory boards for VSL3 and Eisai. GC has received personal fees for acting as advisor for Ferring Therapeutics. GI has received personal fees for acting as speaker for Biocodex, Danone, Sofar, Malesci, Metagenics, Illumina, and Tillotts Pharma and for acting as consultant or advisor for Ferring Therapeutics, Giuliani, Metagenics, and Tillotts Pharma. All other authors declare no competing interests.
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