{
  "abstract": "Introduction: The clinical course of inflammatory bowel disease (IBD) is highly heterogeneous, yet the biological mechanisms underlying this variability, along with robust predictive biomarkers of disease course and treatment response, remain elusive. Most existing multi-omic cohorts recruit patients after IBD diagnosis and following therapeutic exposure, limiting the ability to distinguish between primary disease biology and downstream consequences of chronic inflammation and/or treatment. There is, therefore, a critical unmet need for large-scale, treatment-naïve inception cohorts integrating deep clinical phenotyping with longitudinal multi-omic profiling from the point of IBD diagnosis.\n\nMethods and analysis: Open-IBD is a prospective, multicentre UK inception cohort study recruiting up to 2000 adults referred with suspected IBD, prior to diagnosis and initiation of IBD-specific therapy. Baseline assessment includes detailed clinical metadata collection, patient-reported outcome measures and collection of blood, stool and intestinal biopsy samples. 1000 participants subsequently diagnosed with IBD will be followed for up to 48 months, with repeated clinical assessments, questionnaires and biosampling. Participants not diagnosed with IBD will form a symptomatic control cohort with longitudinal clinical record review. Multi-omic analyses will include human genetics, single-cell transcriptomics of blood and intestinal tissue, stool and intestinal mucosal microbiome characterisation, metabolomics and proteomics. Integrated longitudinal clinical and multi-omic datasets will be generated to characterise early-stage treatment-naïve IBD, identify biomarkers associated with long-term outcomes and nominate causal factors driving IBD pathophysiology.\n\nEthics and dissemination: Ethical approval has been obtained from the Wales Research Ethics Committee 1 (24/WA/0338). All participants provide informed consent before enrolment. Recruitment is ongoing. Study findings will be disseminated through peer-reviewed publications, presentations at scientific meetings and lay summaries.\n\nStudy registration number: ISRCTN15535639.",
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  "affiliations": [
    "Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK",
    "Department of Gastroenterology, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK",
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    "IBD Research Group, University of Exeter, Exeter, UK",
    "Royal Devon University Healthcare NHS Foundation Trust, Exeter, UK",
    "The Edinburgh IBD Unit, Western General Hospital, Edinburgh, UK",
    "King’s College London, London, UK",
    "IBD Unit, Guy’s and St Thomas’ NHS Foundation Trust, London, UK",
    "St George’s University Hospitals NHS Trust, London, UK",
    "NIHR Newcastle Biomedical Research Centre, Newcastle University, Newcastle upon Tyne, UK",
    "Genetic Mechanisms of Disease Laboratory, The Francis Crick Institute, London, UK",
    "Department of Gastroenterology, Royal Free Hospital, London, UK",
    "Institute of Genetics and Cancer, University of Edinburgh, Edinburgh, UK",
    "Blizard Institute, Barts and The London School of Medicine, Queen Mary University of London, London, UK",
    "The Royal London Hospital, Barts Health NHS Trust, London, UK",
    "Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK",
    "Imperial College London, London, UK"
  ],
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  "doi": "10.1136/bmjgast-2026-002501",
  "fulltext_url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC13735373/",
  "id": "5ctpn25n7r9dz",
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  "native_subjects": [
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    [
      "heading",
      "Inflammatory Bowel Disease"
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  "pdf_url": "https://bmjopengastro.bmj.com/content/13/1/e002501.full.pdf",
  "pmcid": "PMC13735373",
  "pmid": "42982526",
  "published": "2026-11-04",
  "publisher": "BMJ Publishing Group",
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  "subjects": [
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      "origin": "openalex:2715|Inflammatory Bowel Disease",
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  "title": "Open-IBD: protocol for a longitudinal multi-omics inception cohort in inflammatory bowel disease",
  "title_text": "Open-IBD: protocol for a longitudinal multi-omics inception cohort in inflammatory bowel disease",
  "type": "peer-reviewed",
  "updated_at": "2026-11-09T12:21:04Z",
  "url": "https://research.draconitic.com/paper/5ctpn25n7r9dz",
  "venue": "BMJ Open Gastroenterology",
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