At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Not specified by the sponsor
- How long the study runs
- Study runs about 60 months (dates as stated)
- About the drug or intervention
- Not specified by the sponsor
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 16 Years and over
- Who
- All
- Number of participants
- 240
- Started
- 2022-12-12
- Last checked
- 2026-06
Plain English Summary
What is this study?
- • Testing a new treatment for gastro-intestinal disorder
- • Clinical study - 240 participants
- • The goal of this observational study is to learn about the comparisons of inflammatory markers between IBD and non-IBD (control) participants
Who can take part?
- • Ages 16 Years and over
- • Diagnosed with gastro-intestinal disorder
Where?
- • Nottingham - University of Nottingham
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 16 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓1\. Provision of signed and dated, written agreement to take part before any study specific procedures
Who cannot take part
- ✗Inability to give agreement to take part
- ✗Any positive result from previous screening for serum hepatitis B surface antigen, hepatitis C or human...
- ✗An ongoing infection requiring treatment
- ✗Clinical evidence of active COVID infection and/or evidence of active COVID determined by local standard care procedures
- ✗Participation in a clinical study with pharmacological intervention within 3 months prior to Baseline visit.
See the full criteria
Where Is This Study? (1 UK site)
University of Nottingham
Nottingham NG7 2UH, United Kingdom
How to Get in Touch
Gordon Moran Professor
Sponsor contactCONTACT
Nadia Frowd
Sponsor contactCONTACT
