Open-IBD: protocol for a longitudinal multi-omics inception cohort in inflammatory bowel disease
Year: 2026
Type: article
Study design: Study Protocol
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.Methods 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.Ethics 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.Study registration number ISRCTN15535639.
Source: BMJ Open Gastroenterology
Authors: Robert J Mulligan, Cristina Cotobal Martin, Dean M Allerton, Michelle Strickland, Irena Bibby, Laura Fachal, Hannah Watson, Georgina Bates, Lauren C Beck, Tariq Ahmad, Jonathan Blackwell, Robin J Dart, Chaonan Dong, Mary Doona, Jennifer Doyle, Tony Fouweather, Elliot Gemmell, Richard Hall, Peter M Irving, Katherine Jacques, Nicholas A Kennedy, Andrew Thomas King, James C Lee, Charlie W Lees, Robert D Lees, James O Lindsay, Andrea C Masi, Christopher Palmer-Jones, Gareth C Parkes, Miles Parkes, Kamal V Patel, Sebastian Povlsen, Nicholas Powell, Jonathan Prichard, Tim Raine, Christopher Roberts, Emmanuel Samuel, R Ally Speight, Sreedhar Subramanian, Paola Reis, Eva Vayreda, Nicola J Wyatt, Open-IBD Collaborators, Christopher J Stewart, Gregory R Young, Naomi McGregor, Carl A Anderson, Christopher A Lamb
Institutions: Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle University, Wellcome Sanger Institute, University of Exeter, Royal Devon University Healthcare NHS Foundation Trust, Western General Hospital, King's College London, Guy's and St Thomas' NHS Foundation Trust, St George’s University Hospitals NHS Foundation Trust, NIHR Newcastle Biomedical Research Centre, The Francis Crick Institute, The Royal Free Hospital, Institute of Genetics and Cancer, University of Edinburgh, Queen Mary University of London, Barts Health NHS Trust, Royal London Hospital, Blizard Institute, Cambridge University Hospitals NHS Foundation Trust, Imperial College London
Language: English
Topic: Inflammatory Bowel Disease
Subfield: Gastroenterology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,085
OpenAlex ID: W7225273786