Evidence map›Paper›PMID 39647502›Full record

ReviewThe lancet. Gastroenterology & hepatology2025

International consensus statement on microbiome testing in clinical practice.

Serena Porcari, Benjamin H Mullish, Francesco Asnicar, Siew C Ng, Liping Zhao, Richard Hansen, Paul W O'Toole, Jeroen Raes, Georgina Hold, Lorenza Putignani and 59 more

Abstract readReviewConsensus Statement
In one paragraph

Review in The lancet. Gastroenterology & hepatology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 71 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
71citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

71 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  13. Gut microbiota in health and disease.Molecular biomedicine · 2026
    Review
  14. Article
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11 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

69 authors.

Serena PorcariDepartment of Translational Medicine and Surgery, Università Cattolica del Sacro Cuore, Rome, Italy; Department of Medical and Surgical Sciences, UOC Gastroenterologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Benjamin H MullishDivision of Digestive Diseases, Department of Metabolism, Digestion and Reproduction, Faculty of Medicine, St Mary's Hospital Campus, Imperial College London, London, UK; Departments of Gastroenterology and Hepatology, St Mary's Hospital, Imperial College Healthcare NHS Trust, London, UK.
Francesco AsnicarDepartment CIBIO, University of Trento, Trento, Italy.
Siew C NgMicrobiota I-Center (MagIC), Hong Kong Special Administrative Region, China; Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong Special Administrative Region, China; Li Ka Shing Institute of Health Sciences, State Key Laboratory of Digestive Disease, Institute of Digestive Disease, The Chinese University of Hong Kong, Hong Kong Special Administrative Region, China.
Liping ZhaoDepartment of Biochemistry and Microbiology, New Jersey Institute of Food, Nutrition and Health, Rutgers University, New Brunswick, NY, USA.
Richard HansenDivision of Molecular and Clinical Medicine, School of Medicine, University of Dundee, Dundee, UK.
Paul W O'TooleAPC Microbiome Ireland, Department of Medicine, University College Cork, Cork, Ireland; School of Microbiology, University College Cork, Cork, Ireland.
Jeroen RaesDepartment of Microbiology, Immunology and Transplantation, Rega Institute for Medical Research, Leuven, Belgium; VIB, Center for Microbiology, Leuven, Belgium.
Georgina HoldMicrobiome Research Centre, University of New South Wales, Sydney, Australia.
Lorenza PutignaniUnit of Microbiomics and Unit of Human Microbiome, Bambino Gesù Children's Hospital, IRCCS, Rome, Italy.
Christian Lodberg HvasDepartment of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus Denmark.
Georg ZellerLeiden University Center for Infectious Diseases (LUCID), Leiden University Medical Center, Leiden, Netherlands; Center for Microbiome Analyses and Therapeutics, Leiden University Medical Center, Leiden, Netherlands; Structural and Computational Biology Unit, European Molecular Biology Laboratory, Heidelberg, Germany.
Omry KorenAzrieli Faculty of Medicine Bar-Ilan University, Safed, Israel.
Hein TunThe Jockey Club School of Public Health and Primary Care, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong Special Administrative Region, China.
Mireia Valles-ColomerDepartment CIBIO, University of Trento, Trento, Italy; MELIS Department, Pompeu Fabra University, Barcelona, Spain.
Maria Carmen ColladoInstitute of Agrochemistry and Food Technology-National Research Council (IATA-CSIC), Valencia, Spain.
Monika FischerDivision of Gastroenterology, Indiana University School of Medicine, Indianapolis, IN, USA.
Jessica AllegrettiDivision of Gastroenterology, Brigham and Women's Hospital, Boston, MA, USA.
Tariq IqbalDepartment of Gastroenterology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK; Microbiome Treatment Centre, University of Birmingham, Edgbaston, UK.
Benoit ChassaingMicrobiome-Host Interactions, Institut Pasteur, Université Paris Cité, INSERM, Paris, France.
Josbert KellerDepartment of Gastroenterology and Hepatology, Leiden University Medical Center, Leiden, Netherlands; Public Health Laboratory, Faculty of Medicine, University of Birmingham, Birmingham, UK.
Simon Mark BaunwallDepartment of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus Denmark; Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
Maria AbreuDivision of Gastroenterology, Department of Medicine, University of Miami Miller School of Medicine, Miami, FL, USA.
Giovanni BarbaraIRCCS Azienda Ospedaliero, University of Bologna, Bologna, Italy; Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.
Faming ZhangMedical Center for Digestive Diseases, the Second Affiliated Hospital of Nanjing Medical University, Nanjing, China; Key Lab of Holistic Integrative Enterology, Nanjing Medical University, Nanjing, China.
Francesca Romana PonzianiDepartment of Translational Medicine and Surgery, Università Cattolica del Sacro Cuore, Rome, Italy; Liver Unit-Department of Medical and Surgical Sciences, UOC CEMAD Centro Malattie dell'Apparato Digerente, Medicina Interna e Gastroenterologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Sam P CostelloDepartment of Gastroenterology, The Queen Elizabeth Hospital, Adelaide, South Australia, Australia; Faculty of Health and Medical Sciences, Adelaide Medical School, University of Adelaide, Adelaide, South Australia, Australia.
Sudarshan ParamsothyDepartment of Gastroenterology and Hepatology, Concord Repatriation General Hospital, Sydney, Australia; Concord Clinical School, University of Sydney, Sydney, Australia.
Dina KaoEdmonton FMT program, Division of Gastroenterology, University of Alberta, Edmonton, AB, Canada.
Colleen KellyDivision of Gastroenterology, Brigham and Women's Hospital, Boston, MA, USA.
Juozas KupcinskasGastroenterology Department and Institute for Digestive Research; Lithuanian University of Health Sciences Kaunas, Lithuania.
Ilan YoungsterDivision of Pediatrics and the Center for Microbiome Research, Shamir Medical Center, Israel, Faculty of Medical & Health Sciences, Tel-Aviv University, Tel-Aviv, Israel.
Francesco FranceschiDepartment of Emergency Medicine, Fondazione Policlinico Universitario, Università Cattolica del Sacro Cuore, Rome, Italy.
Sahil KhannaDivision of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.
Maria VehreschildGoethe University Frankfurt, University Hospital Frankfurt, Department II of Internal Medicine, Infectious Diseases, Frankfurt am Main, Germany.
Alexander LinkDepartment of Gastroenterology, Hepatology and Infectious Diseases, Otto-von-Guericke University, Magdeburg, Germany.
Flavio De MaioDepartment of Laboratory and Infectious Sciences, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Edoardo PasolliUniversity of Naples Federico II, Department of Agricultural Sciences, Portici, Italy.
Aitor Blanco MiguezDepartment CIBIO, University of Trento, Trento, Italy.
Patrizia BrigidiMicrobiomics Unit, Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.
Brunella PosteraroDepartment of Basic Biotechnological Sciences, Intensive and Perioperative Clinics, Università Cattolica del Sacro Cuore, Rome, Italy.
Franco ScaldaferriDepartment of Translational Medicine and Surgery, Università Cattolica del Sacro Cuore, Rome, Italy; Department of Medical and Surgical Sciences, UOC Gastroenterologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Mirjana Rajilic StojanovicDepartment for Biochemical Engineering and Biotechnology, University of Belgrade, Belgrade, Serbia; Faculty of Technology and Metallurgy, University of Belgrade, Belgrade, Serbia.
Francis MegraudINSERM U1312 BRIC, Université de Bordeaux, Bordeaux, France.
Peter MalfertheinerDepartment of Gastroenterology, Hepatology and Infectious Diseases, Otto-von-Guericke University, Magdeburg, Germany; LMU, University Clinic, Medical Department II, Munich, Germany.
Luca MasucciDepartment of Laboratory and Infectious Sciences, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Manimozhiyan ArumugamNovo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
Nadeem KaakoushSchool of Biomedical Sciences, University of New South Wales, Sydney, Australia.
Eran SegalComputer Science and Applied Mathematics Department, Weizmann Institute of Science, Rehovot, Israel.
Jasmohan BajajDivision of Gastroenterology, Hepatology, and Nutrition, Virginia Commonwealth University and Richmond VA Medical Center, Richmond, VA, USA.
Rupert LeongDepartment of Gastroenterology, Concord Repatriation General Hospital, Sydney, Australia; MQ Health, Macquarie University Hospital, Sydney, Australia.
John CryanAPC Microbiome Ireland, Department of Medicine, University College Cork, Cork, Ireland.
Rinse K WeersmaDepartment of Gastroenterology and Hepatology, University of Groningen and University Medical Center Groningen, Groningen, Netherlands.
Robert KnightCenter for Microbiome Innovation, University of California San Diego, La Jolla, CA, USA.
Francisco GuarnerCentro Médico Teknon, Barcelona, Spain.
Fergus ShanahanAPC Microbiome Ireland, Department of Medicine, University College Cork, Cork, Ireland.
Patrice D CaniLouvain Drug Research Institute (LDRI), Metabolism and Nutrition Research Group, UCLouvain, Université Catholique de Louvain, Brussels, Belgium; Institute of Experimental and Clinical Research (IREC), UCLouvain, Université Catholique de Louvain, Brussels, Belgium; Walloon Excellence in Life Sciences and BIOtechnology (WELBIO), WELBIO department, WEL Research Institute, Wavre, Belgium.
Eran ElinavSystems Immunology Department, Weizmann Institute of Science, Rehovot, Israel; Cancer-Microbiome Division, Deutsches Krebsforschungszentrum (DKFZ), Heidelberg, Germany.
Maurizio SanguinettiDepartment of Laboratory and Infectious Sciences, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Willem M de VosLaboratory of Microbiology, Wageningen University, Netherlands; Human Microbiome Research Program, University of Helsinki, Finland.
Emad El-OmarMicrobiome Research Centre, St George & Sutherland Clinical Campuses, School of Clinical Medicine, University of New South Wales, Sydney, Australia.
Joel DorèMR Micalis Institut, INRA, Paris-Saclay University, Jouy-En-Josas, France.
Julian MarchesiDivision of Digestive Diseases, Department of Metabolism, Digestion and Reproduction, Faculty of Medicine, St Mary's Hospital Campus, Imperial College London, London, UK.
Herbert TilgDepartment of Internal Medicine I, Gastroenterology, Hepatology, Endocrinology & Metabolism, Medical University of Innsbruck, Innsbruck, Austria.
Harry SokolMR Micalis Institut, INRA, Paris-Saclay University, Jouy-En-Josas, France; Gastroenterology Department, Sorbonne Université, INSERM, Centre de Recherche Saint-Antoine, CRSA, AP-HP, Saint-Antoine Hospital, Paris, France; Paris Center for Microbiome MedICIsne (PaCeMM) FHU, Paris, France.
Nicola SegataDepartment CIBIO, University of Trento, Trento, Italy; Department of Experimental Oncology, European Institute of Oncology IRCCS, Milan, Italy.
Giovanni CammarotaDepartment of Translational Medicine and Surgery, Università Cattolica del Sacro Cuore, Rome, Italy; Department of Medical and Surgical Sciences, UOC Gastroenterologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Antonio GasbarriniDepartment of Translational Medicine and Surgery, Università Cattolica del Sacro Cuore, Rome, Italy; Department of Medical and Surgical Sciences, UOC Gastroenterologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Gianluca IaniroDepartment of Translational Medicine and Surgery, Università Cattolica del Sacro Cuore, Rome, Italy; Department of Medical and Surgical Sciences, UOC Gastroenterologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy. Electronic address: gianluca.ianiro@unicatt.it.

Funding

Linking microbiome genetic variants with cardiovascular phenotypes in 50,000 individualsR01HL160862 · NHLBI · J. DAVID GLADSTONE INSTITUTES · PI POLLARD, KATHERINE S. · 2022 to 2025
$2.7M
Exploiting public metagenomic data to uncover cancer-microbiome relationshipsU01CA230551 · NCI · GRADUATE SCHOOL OF PUBLIC HEALTH AND HEALTH POLICY · PI WALDRON, LEVI · 2019 to 2019
$464k
NCI NIH HHS U01 CA230551NHLBI NIH HHS R01 HL160862
6 · The paper itself

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.

Indexed as

Gastrointestinal MicrobiomeHumansMicrobiota

Identifiers

PMID39647502
PMCPMC12343204

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.