{
  "abstract": "Background and aims Restoration of intestinal barrier integrity and function in inflammatory bowel disease (IBD) has been associated not only with a reduced burden of persistent symptoms but also with improved long-term outcomes, prompting growing interest in intestinal barrier healing as a potential new therapeutic target. To date, no clinical trials have specifically evaluated therapies aimed at restoring intestinal barrier function in IBD, and there is currently no consensus on how such trials should be designed or how the intestinal barrier should be assessed. The aim of this initiative was to develop consensus recommendations on the optimal design of clinical trials and the selection of tools to evaluate therapies targeting the intestinal barrier in IBD.Methods A panel of 12 international specialists with recognised expertise in the intestinal barrier and/or IBD clinical trials evaluated statements developed from a systematic literature review. Statements were discussed and anonymously voted on using a modified Delphi methodology. Consensus was predefined as at least 75% agreement among participants. The study was conducted and reported in accordance with the Conducting and REporting of DElphi Studies framework.Results Fourteen statements reached consensus and were approved. These statements addressed key aspects of clinical trial design, including the role of intestinal barrier assessment as an endpoint, timing of reassessment, protocol requirements and disease-specific considerations. Additional statements focused on the selection and standardisation of tools for intestinal barrier assessment, encompassing imaging-based techniques, functional permeability assays and endogenous biomarkers, as well as considerations for implementation and future research directions.Conclusions This international consensus provides a structured framework to guide the design of future clinical trials evaluating efficacies of therapies in restoring intestinal barrier integrity and/or function in IBD.",
  "authors": [
    {
      "affiliations": [
        "Department of Gastroenterology, Cliniques universitaires Saint-Luc, Brussels, Belgium"
      ],
      "name": "Sophie Vieujean"
    },
    {
      "affiliations": [
        "Medical Department 1, University Hospital Erlangen, Friedrich-Alexander-University of Erlangen-Nürnberg, Erlangen, Germany"
      ],
      "name": "Raja Atreya"
    },
    {
      "affiliations": [
        "Gastroenterology Unit, Department of Gastrointestinal Oncological Surgery, S. Maria del Prato Hospital, Feltre, Italy"
      ],
      "name": "Andrea Buda"
    },
    {
      "affiliations": [
        "Department of Molecular and Cellular Biology, University of Geneva, Geneva, Switzerland"
      ],
      "name": "Sandra Citi"
    },
    {
      "affiliations": [
        "Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele, Milano, Italy"
      ],
      "name": "Silvio Danese"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Cliniques universitaires Saint-Luc, Brussels, Belgium"
      ],
      "name": "Olivier Dewit"
    },
    {
      "affiliations": [
        "Translational Gastroenterology and Liver Unit and NIHR Biomedical Research Centre, University of Oxford, Oxford, UK"
      ],
      "name": "Matthias Friedrich"
    },
    {
      "affiliations": [
        "APC Microbiome Ireland, College of Medicine and Health, University College Cork, Cork, Ireland"
      ],
      "name": "Subrata Ghosh"
    },
    {
      "affiliations": [
        "APC Microbiome Ireland, College of Medicine and Health, University College Cork, Cork, Ireland"
      ],
      "name": "Marietta Iacucci"
    },
    {
      "affiliations": [
        "Department of Medicine, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada"
      ],
      "name": "Vipul Jairath"
    },
    {
      "affiliations": [
        "Cambridge Institute of Therapeutic Immunology and Infectious Disease, University of Cambridge, Cambridge, UK",
        "Division of Gastroenterology and Hepatology, Department of Medicine, University of Cambridge, Cambridge, UK"
      ],
      "name": "Arthur Kaser"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Macquarie University Hospital, Sydney, New South Wales, Australia"
      ],
      "name": "Rupert Leong"
    },
    {
      "affiliations": [
        "MFN Department of Medicine 1, Ludwig Demling Center of Excellence in Endoscopy, Deutsches Zentrum Immuntherapie DZI, FAU University Erlangen-Nürnberg, Erlangen, Germany"
      ],
      "name": "Markus F Neurath"
    },
    {
      "affiliations": [
        "Independant researcher, Liege, Belgium"
      ],
      "name": "Nicolas Pierre"
    },
    {
      "affiliations": [
        "Immunoconcept UMR 5164 University of Bordeaux – Immunology and immunogenetic Unit, Bordeaux, France"
      ],
      "name": "Mathilde Pohin"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, University Hospital Erlangen, Ludwig Demling Endoscopy Center, Erlangen, Germany"
      ],
      "name": "Timo Rath"
    },
    {
      "affiliations": [
        "Service d’Hépato-gastroentérologie et oncologie digestive, CHU de Bordeaux. ImmunoConcept UMR5164, University of Bordeaux, Bordeaux, France"
      ],
      "name": "Pauline Rivière"
    },
    {
      "affiliations": [
        "Kennedy Institute of Rheumatology, Translational Gastroenterology and Liver Unit and NIHR Biomedical Research Centre, Oxford, UK"
      ],
      "name": "Simon Travis"
    },
    {
      "affiliations": [
        "Department of Visceral Surgery and Medicine, Inselspital - Bern University Hospital, University of Bern, Bern, Switzerland"
      ],
      "name": "Sebastian Zeissig"
    },
    {
      "affiliations": [
        "Northwestern Medicine, Digestive Health Institute, Chicago, IL, USA"
      ],
      "name": "Laurent Peyrin-Biroulet"
    }
  ],
  "title": "International consensus on intestinal epithelial barrier assessment and therapeutic effects in inflammatory bowel diseases clinical trials",
  "uid": "4829409d-96af-55bf-82d3-b57c60e9d42a"
}