Scientists hunt for hidden clues to inflammatory bowel disease
NCT ID NCT06956703
First seen Jul 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time
Summary
This observational study compares inflammatory markers in the blood and tissue of people with active Crohn's disease or ulcerative colitis versus healthy volunteers. Researchers aim to identify differences in the IL-23/Th17 inflammatory pathway and other immune signals. The study involves 240 participants and includes analysis of stool samples and genetic material. Findings may help uncover new targets for future treatments.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If differences in inflammatory markers are found, this could point toward new targets for treating IBD.
- What could go wrong
- This is an observational study, not a treatment trial. It may not lead to any direct benefit for participants.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
About 240 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Dec 2022
- Expected to finish
-
Dec 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
A cohort study in patients with moderate to severely active Crohn's 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. We 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.
- Ages
-
16 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1\. Provision of signed and dated, written informed consent before any study specific procedures AND 2a. Patients of at least 16 years of age with active Crohn's disease defined as: CRP \> = 5 mg/L OR FCP \> = 250 μg/g OR Visible ulcerations on ileocolonoscopy with a total SES-CD \> = 7, or \> = 4 if disease is confined to the terminal ileum OR visable active disease on cross-sectional imaging. Are switching to a new mechanism of action (MOA) onto anti-TNF therapy or ustekinumab or upadacitinib OR 2b. Patients of at least 16 years (no upper age limit) with active UC defined as: CRP \> = 5 mg/L OR FCP \> = 250 μg/g OR Mayo endoscopy subscore \> = 2. Are switching to a new mechanism of action (MOA) onto either anti-TNFα therapy or vedolizumab OR 2c. Non-IBD participants who are attending for a lower GI colonoscopy at any participating site. On any hospital/ medical/ clinical screening list or any other appropriate list with no pathology found on examination. Exclusion Criteria: 1. Inability to give informed consent 2. Any positive result from previous screening for serum hepatitis B surface antigen, hepatitis C or human immunodeficiency virus (HIV) 3. An ongoing infection requiring treatment 4. Clinical evidence of active COVID infection and/or evidence of active COVID determined by local standard care procedures 5. Participation in a clinical study with pharmacological intervention within 3 months prior to Baseline visit. 6. Current diagnosis of cancer 7. Having received a solid organ or stem cell transplant 8. Having received a transfusion of blood, plasma, or platelets within 120 days prior to enrolment 9. Confirmed pregnancy at time of enrolment 10. For non-IBD participants: A prior history of IBD (CD, UC, microscopic colitis, indeterminate colitis or IBD unspecified) 11. Clinical judgement by the investigator that the patient should not participate in the study 12. Under 16yrs of age
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Crohn disease are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
University of Nottingham
RECRUITINGNottingham, Nottinghamshire, NG7 2UH, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A randomized, wait List-Controlled, clinical trial of IBD strong peer for Self-Management of psychological distress by persons living with inflammatory bowel diseases (IBD)
- A simple stool test might replace scopes for kids with gut issues
- Can a new pill tame inflammatory bowel disease?
- Can a new infusion drug calm ulcerative colitis?
- Can diet and blood tests predict IBD Flare-Ups?
- A breath test for gut disease? researchers hunt for invisible clues