Open-IBD: protocol for a longitudinal multi-omics inception cohort in inflammatory bowel disease
18 affiliations
- 1Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK
- 2Department of Gastroenterology, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK
- 3Human Genetics, Wellcome Sanger Institute, Hinxton, UK
- 4Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK
- 5IBD Research Group, University of Exeter, Exeter, UK
- 6Royal Devon University Healthcare NHS Foundation Trust, Exeter, UK
- 7The Edinburgh IBD Unit, Western General Hospital, Edinburgh, UK
- 8King’s College London, London, UK
- 9IBD Unit, Guy’s and St Thomas’ NHS Foundation Trust, London, UK
- 10St George’s University Hospitals NHS Trust, London, UK
- 11NIHR Newcastle Biomedical Research Centre, Newcastle University, Newcastle upon Tyne, UK
- 12Genetic Mechanisms of Disease Laboratory, The Francis Crick Institute, London, UK
- 13Department of Gastroenterology, Royal Free Hospital, London, UK
- 14Institute of Genetics and Cancer, University of Edinburgh, Edinburgh, UK
- 15Blizard Institute, Barts and The London School of Medicine, Queen Mary University of London, London, UK
- 16The Royal London Hospital, Barts Health NHS Trust, London, UK
- 17Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK
- 18Imperial College London, London, UK
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.
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BibTeX
@article{mulligan2026openibd,
title = {{Open-IBD: protocol for a longitudinal multi-omics inception cohort in inflammatory bowel disease}},
author = {Robert J Mulligan and Cristina Cotobal Martin and Dean M Allerton and Michelle Strickland and Irena Bibby and Laura Fachal and Hannah Watson and Georgina Bates and Lauren C Beck and Tariq Ahmad and Jonathan Blackwell and Robin J Dart and Chaonan Dong and Mary Doona and Jennifer Doyle and Tony Fouweather and Elliot Gemmell and Richard Hall and Peter M Irving and Katherine Jacques and Nicholas A Kennedy and Andrew Thomas King and James C Lee and Charlie W Lees and Robert D Lees and James O Lindsay and Andrea C Masi and Christopher Palmer-Jones and Gareth C Parkes and Miles Parkes and Kamal V Patel and Sebastian Povlsen and Nicholas Powell and Jonathan Prichard and Tim Raine and Christopher Roberts and Emmanuel Samuel and R Ally Speight and Sreedhar Subramanian and Paola Reis and Eva Vayreda and Nicola J Wyatt and Debbie Alexander and Christopher J Stewart and Gregory R Young and Naomi McGregor and Carl A Anderson and Christopher A Lamb},
journal = {BMJ Open Gastroenterology},
year = {2026},
month = nov,
doi = {10.1136/bmjgast-2026-002501},
url = {https://doi.org/10.1136/bmjgast-2026-002501},
note = {CC BY-NC 4.0},
}
RIS
TY - JOUR
TI - Open-IBD: protocol for a longitudinal multi-omics inception cohort in inflammatory bowel disease
AU - Robert J Mulligan
AU - Cristina Cotobal Martin
AU - Dean M Allerton
AU - Michelle Strickland
AU - Irena Bibby
AU - Laura Fachal
AU - Hannah Watson
AU - Georgina Bates
AU - Lauren C Beck
AU - Tariq Ahmad
AU - Jonathan Blackwell
AU - Robin J Dart
AU - Chaonan Dong
AU - Mary Doona
AU - Jennifer Doyle
AU - Tony Fouweather
AU - Elliot Gemmell
AU - Richard Hall
AU - Peter M Irving
AU - Katherine Jacques
AU - Nicholas A Kennedy
AU - Andrew Thomas King
AU - James C Lee
AU - Charlie W Lees
AU - Robert D Lees
AU - James O Lindsay
AU - Andrea C Masi
AU - Christopher Palmer-Jones
AU - Gareth C Parkes
AU - Miles Parkes
AU - Kamal V Patel
AU - Sebastian Povlsen
AU - Nicholas Powell
AU - Jonathan Prichard
AU - Tim Raine
AU - Christopher Roberts
AU - Emmanuel Samuel
AU - R Ally Speight
AU - Sreedhar Subramanian
AU - Paola Reis
AU - Eva Vayreda
AU - Nicola J Wyatt
AU - Debbie Alexander
AU - Christopher J Stewart
AU - Gregory R Young
AU - Naomi McGregor
AU - Carl A Anderson
AU - Christopher A Lamb
PY - 2026
DA - 2026/11/04
JO - BMJ Open Gastroenterology
DO - 10.1136/bmjgast-2026-002501
UR - https://doi.org/10.1136/bmjgast-2026-002501
AB - 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.
SN - 2054-4774
ER -