The goal of this observational study is to learn about the comparisons of inflammatory markers between IBD and non-IBD (control) participants. The main question it aims to answer is: Are there differences in inflammatory markers between IBD and non-IBD (control) participants.
A cohort study in patients with moderate to severely active Crohns Disease (CD) and Ulcerative Colitis (UC) who are switching to new targeted biologic therapy (with a different mode of action) - onto either anti-TNFα therapy or vedolizumab for UC or onto anti-TNFα therapy or ustekinumab or upadacitinib for CD and undergoing routine endoscopic assessments as part of normal clinical practice. The investigator will also recruit participants without these conditions (controls) who are due for a lower GI colonoscopy as part of the UK national bowel cancer screening programme or on any hospital/ medical/ clinical screening list or any other appropriate list with no pathology found on examination. CD \& UC patients will provide blood and stool samples at 3 timepoints (baseline, 3mths, 12mths) as well as extra tissue biopsies taken at standard care endoscopies within 12mths. Controls will provide a blood sample and stool sample as well as extra tissue biopsies taken at standard care colonoscopies. Samples will be analysed to characterise any observable traits (phenotype) and molecular variability in patients which may be associated with clinical response to the treatment. The investigator hopes the information gained from this study may help improve the understanding of Inflammatory Bowel Diseases (IBD) and help to develop better ways of treating the condition and predicting the course of the disease and how patients may respond to different treatments.
Study Type
OBSERVATIONAL
Enrollment
240
University of Nottingham
Nottingham, Nottinghamshire, United Kingdom
RECRUITINGThe comparison of the IL-23/Th17 inflammatory axis between IBD and healthy control samples
Time frame: Baseline, Month 3 and Month 12
Characterisation of IL-23/Th17 inflammatory axis within IBD biosamples stratified by prior biologic exposure
Time frame: Baseline, Month 3 and Month 12
Comparison of mRNA sequencing readouts, characterisation of tissue and immune cell populations, characterisation of protein expression and characterisation of microbial species in the stool and tissue
The above will be stratified by disease type and status, demographic features of the participant, biologic exposure, clinical and endoscopic response to treatment
Time frame: Baseline, Month 3 and Month 12
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