The number of new people being diagnosed with Crohn's disease and ulcerative colitis, collectively known as inflammatory bowel disease (IBD), is rising each year. Symptoms can be very different from one person to the next - some people will have inflammation which gets worse over time whereas in others the inflammation is easily treated.
Unfortunately, we don’t know why Crohn’s and colitis starts or what controls this behaviour over time. The aims of Open-IBD are to identify molecular, cellular, bacterial and viral biomarkers of long-term health outcomes in IBD and identify causal factors driving IBD pathology. To do this we will recruit up to 2,000 research participants from patients who may be diagnosed with IBD.
Patients with suspected IBD will be consented to the study and blood, stool and tissue samples will be collected along with medical history and symptom data. Blood and tissue samples collected at the participating hospital sites will be sent to Sanger for storage and processing. The Wellcome Sanger Institute will generate single cell gene expression data and participant whole genome sequencing to understand patient variants contributing to disease and response to treatment.
Stool samples will be collected by patients at home and sent to Newcastle University. Newcastle will conduct faecal calprotectin assays as a measure of disease activity and response to treatment. Newcastle will conduct analysis of the participant gut microbiome (including bacteria and viruses, fungi and archaea) and metabolome analysis to identify markers of disease and response.
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Inclusion and Exclusion Criteria
Inclusion Criteria
All patients must fulfil the following criteria to be enrolled in the study.
Suspected diagnosis of IBD i.e. referred to/presenting within hospital as part of the IBD diagnosis pathway, for example: - 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). - 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. - 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.
- Patients presenting/admitted to hospital with suspected or confirmed new onset inflammatory bowel disease.
Adults aged 16 years and over
Willing and able to provide informed consent
Willing to undertake the following study procedures: - Completion of questionnaires - Collection of stool specimens at home - 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.
Exclusion Criteria
The following exclusion criteria apply:
Potential participants should not be currently receiving treatment with oral or rectal corticosteroids, 5-aminosalicylates, or advanced therapies (biologics, JAKi or S1P receptor modulator) if commenced as treatment for suspected IBD. - 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.The exception are patients admitted to hospital due to suspected new onset inflammatory bowel disease consistent with acute severe colitis (ASC) who have received seven 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.
- 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.
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.
- 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.
Known blood borne virus infection due to human immunodeficiency virus (HIV), hepatitis B virus or hepatitis C virus.
