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Review
. 2025 Feb;10(2):154-167.
doi: 10.1016/S2468-1253(24)00311-X. Epub 2024 Dec 5.

International consensus statement on microbiome testing in clinical practice

Serena Porcari  1 Benjamin H Mullish  2 Francesco Asnicar  3 Siew C Ng  4 Liping Zhao  5 Richard Hansen  6 Paul W O'Toole  7 Jeroen Raes  8 Georgina Hold  9 Lorenza Putignani  10 Christian Lodberg Hvas  11 Georg Zeller  12 Omry Koren  13 Hein Tun  14 Mireia Valles-Colomer  15 Maria Carmen Collado  16 Monika Fischer  17 Jessica Allegretti  18 Tariq Iqbal  19 Benoit Chassaing  20 Josbert Keller  21 Simon Mark Baunwall  22 Maria Abreu  23 Giovanni Barbara  24 Faming Zhang  25 Francesca Romana Ponziani  26 Sam P Costello  27 Sudarshan Paramsothy  28 Dina Kao  29 Colleen Kelly  18 Juozas Kupcinskas  30 Ilan Youngster  31 Francesco Franceschi  32 Sahil Khanna  33 Maria Vehreschild  34 Alexander Link  35 Flavio De Maio  36 Edoardo Pasolli  37 Aitor Blanco Miguez  3 Patrizia Brigidi  38 Brunella Posteraro  39 Franco Scaldaferri  1 Mirjana Rajilic Stojanovic  40 Francis Megraud  41 Peter Malfertheiner  42 Luca Masucci  36 Manimozhiyan Arumugam  43 Nadeem Kaakoush  44 Eran Segal  45 Jasmohan Bajaj  46 Rupert Leong  47 John Cryan  48 Rinse K Weersma  49 Robert Knight  50 Francisco Guarner  51 Fergus Shanahan  48 Patrice D Cani  52 Eran Elinav  53 Maurizio Sanguinetti  36 Willem M de Vos  54 Emad El-Omar  55 Joel Dorè  56 Julian Marchesi  57 Herbert Tilg  58 Harry Sokol  59 Nicola Segata  60 Giovanni Cammarota  1 Antonio Gasbarrini  1 Gianluca Ianiro  61
Affiliations
Review

International consensus statement on microbiome testing in clinical practice

Serena Porcari et al. Lancet Gastroenterol Hepatol. 2025 Feb.

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.

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Conflict of interest statement

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.

References

    1. Fan Y, Pedersen O. Gut microbiota in human metabolic health and disease. Nat Rev Microbiol 2021; 19: 55–71. - PubMed
    1. Spencer SP, Fragiadakis GK, Sonnenburg JL. Pursuing Human-Relevant Gut Microbiota-Immune Interactions. Immunity 2019; 51: 225–39. - PMC - PubMed
    1. Libertucci J, Young VB. The role of the microbiota in infectious diseases. Nat Microbiol 2019; 4: 35–45. - PubMed
    1. Koppel N, Maini Rekdal V, Balskus EP. Chemical transformation of xenobiotics by the human gut microbiota. Science 2017; 356: eaag2770. - PMC - PubMed
    1. de Vos WM, Tilg H, Van Hul M, Cani PD. Gut microbiome and health: mechanistic insights. Gut 2022; 71: 1020–32. - PMC - PubMed

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