Inflammatory bowel disease Digestive System
Conditions
Interventions
Open-IBD is a multi-centre, prospective, observational, inception cohort study of inflammatory bowel disease (comprising Crohn’s disease and ulcerative colitis) with approximately seven UK sites.
The
anticipated 50:50 split between ulcerative colitis/inflammatory bowel disease unclassified (IBD-U) and Crohn’s disease.
2. ‘Non-IBD cohort’ = additional subjects referred to hospital with suspected IB
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
16 Years to 120 Years
Inclusion criteria
Inclusion criteria: Current key inclusion criteria as of 09/09/2026: All patients must fulfil the following criteria to be enrolled in the study. 1. Suspected diagnosis of IBD i.e. referred to/presenting within hospital as part of the IBD diagnosis pathway, for example: 1.1. People being referred from primary care to secondary care with gastrointestinal symptoms and/or tests available in primary care suggestive of gastrointestinal pathology that may be due to inflammatory bowel disease e.g. a raised faecal calprotectin or faecal immunochemical test (FIT) 1.2. People being referred between or within secondary care specialties with test results or symptoms suggestive of gastrointestinal pathology that may be due to inflammatory bowel disease 1.3. People identified in secondary care services to have radiological features of inflammatory bowel disease but where diagnostic lower gastrointestinal endoscopy has yet to happen or is not planned e.g. ileitis or perianal sepsis identified on cross-sectional imaging 1.4. Patients presenting/admitted to hospital with suspected or confirmed new onset inflammatory bowel disease 2. Adults aged 16 years and over 3. Willing and able to provide informed consent 4. Willing to undertake the following study procedures: 4.1. Completion of questionnaires 4.2. Collection of stool specimens at home 4.3. Provision of blood and biopsy samples during hospital visits. For the avoidance of doubt patients can still be recruited where biopsy samples cannot be routinely collected e.g. inflammation beyond the reach of standard endoscopy e.g. in the mid to proximal small bowel, or inability to perform endoscopy due to perianal sepsis. These patients may still be recruited and sampling undertaken if and when possible and clinically appropriate. We anticipate this will be relevant to only a small proportion of participants. _____ Previous key inclusion criteria: All patients must fulfil the following criteria to be enrolled in the study. 1. Suspected diagnosis of IBD i.e. referred to/presenting within hospital as part of the IBD diagnosis pathway, for example: 1.1. People being referred from primary care to secondary care with gastrointestinal symptoms and/or tests available in primary care suggestive of gastrointestinal pathology that may be due to inflammatory bowel disease e.g. a raised faecal calprotectin or faecal immunochemical test (FIT). 1.2. People being referred between or within or between secondary care specialties with test results or symptoms suggestive of gastrointestinal pathology that may be due to inflammatory bowel disease. 1.3. People identified in secondary care services to have radiological features of inflammatory bowel disease but where diagnostic lower gastrointestinal endoscopy has yet to happen or is not planned e.g. ileitis or perianal sepsis identified on cross-sectional imaging. 1.4. Patients presenting/admitted to hospital with suspected or confirmed new onset inflammatory bowel disease. 2. Adults aged 16 years and over 3. Willing and able to provide informed consent 4. Willing to undertake the following study procedures: 4.1. Completion of questionnaires 4.2. Collection of stool specimens at home 4.3. Provision of blood and biopsy samples during hospital visits
Exclusion criteria
Exclusion criteria: Current key exclusion criteria as of 09/09/2026: The following exclusion criteria apply: 1. Potential participants should not be currently receiving treatment with oral or rectal corticosteroids, 5-aminosalicylates or advanced therapies (biologic, JAKi or S1P receptor modulator) if commenced as treatment for suspected IBD 1.1. The exception are patients admitted to hospital due to suspected new onset inflammatory bowel disease. This includes individuals presenting with clinical features consistent with acute severe colitis (ASC), severe Crohn’s disease, peri-anal sepsis, or IBD-related complications such as gastrointestinal strictures or obstruction. These patients may be included if they have received seven days or less of IBD-specific treatment. Permitted treatments within this group include oral, rectal or intravenous corticosteroids, oral or rectal 5-aminosalicylates or advanced IBD therapies. Research staff should aim to approach potentially suitable patients early to facilitate obtaining endoscopic biopsies if possible and minimise the duration of treatment exposure prior to obtaining biosamples. For the avoidance of doubt, the first day of prescribed corticosteroids or advanced therapy will count as day 0 1.2. Receipt of corticosteroids or an advanced therapy at the time of enrolment, for an indication other than inflammatory bowel disease, including psoriasis, uveitis, axial spondyloarthritis, autoimmune liver disease or microscopic colitis is not an exclusion 2. Participants who have already undergone diagnostic lower GI endoscopy will be excluded unless a further endoscopic procedure is planned/likely where treatment-naïve biopsies could be collected or if the suspected disease is beyond the reach of diagnostic ileocolonoscopy 2.1. The exception are patients who are recruited as inpatients, as outlined above, and have already undergone a colonoscopy or flexible sigmoidoscopy. These patients may be enrolled provided they meet the remainder of the eligibility criteria irrespective of whether a lower gastrointestinal endoscopy has been performed or not 3. Known blood borne virus infection due to human immunodeficiency virus (HIV), hepatitis B virus or hepatitis C virus 4. Presence of a stoma _____ Previous key exclusion criteria: The following exclusion criteria apply: 1. Potential participants should not be currently receiving treatment with oral corticosteroids or an advanced therapy (biologic, JAKi or S1P receptor modulator) if commenced as treatment for suspected IBD 1.1. The exception are patients admitted to hospital due to suspected new onset inflammatory bowel disease consistent with acute severe colitis (ASC) who have received 7 days or less of oral or intravenous corticosteroids or advanced IBD therapies. Research staff should aim to approach potentially suitable patients early to facilitate obtaining endoscopic biopsies if possible and minimise the duration of treatment exposure prior to obtaining biosamples. For the avoidance of doubt, the first day of prescribed corticosteroids or advanced therapy will count as day 0 1.2. Receipt of corticosteroids or an advanced therapy at the time of enrolment, for an indication other than inflammatory bowel disease, including psoriasis, uveitis, axial spondyloarthritis, autoimmune liver disease or microscopic colitis is not an exclusion 2. Participants who have already undergone diagnostic lower GI endoscopy will be excluded unless a further endoscopic procedure is planned/li
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recruitment of 2000 patients within 4 years: The number of recruited participants will be reported through the recruitment report generated at the end of the recruitment period. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical disease activity measured using the patient-reported outcome (PRO)-2 at baseline and months 3, 6, 9, 12, 18 and 24 2. Endoscopic disease activity measured using the ulcerative colitis endoscopic index of severity (UCEIS) or the Simple Endoscopic Score for Crohn’s Disease (SES-CD) at baseline and month 12 3. Patient report measure of disease control measured using IBD Control at baseline and months 3, 6, 9, 12, 18 and 24 | — |
Countries
England, United Kingdom
Contacts
Public ContactCarol;Irena Shields;Bibby
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Outcome results
None listed