Status:
NOT_YET_RECRUITING
IBDminds - Mapping the Influence of aNxiety and DepreSsion on IBD
Lead Sponsor:
The Royal Wolverhampton Hospitals NHS Trust
Conditions:
Inflammatory Bowel Diseases
Mental Health Issue
Eligibility:
All Genders
16+ years
Brief Summary
People with Inflammatory bowel disease (IBD) can get challenging symptoms. Things like diarrhoea, tummy pain and being tired all the time are common. People often get IBD in their teens or twenties. T...
Detailed Description
The treatment of moderate to severe Inflammatory Bowel Disease (IBD) now consists of a wide selection advanced therapies1. Despite these, the efficacy of advanced therapy has reached a ceiling at appr...
Eligibility Criteria
Inclusion
- Patients with a confirmed diagnosis of ulcerative colitis, or Crohn's disease, based upon either the outcome of the local multidisciplinary team, clinic documentation or in the opinion of the investigator
- Patients receiving maintenance infliximab or vedolizumab by regular intravenous infusion
- Patients willing and able to give informed consent
- Patients aged 16 or over
Exclusion
- Patients cannot be recruited while receiving their loading dose of infusions, but may be included once complete.
- Patients should not currently be planned for surgery within the next 12 months
- Patients should not currently be planned to switch to another advanced therapy within the next 12 months
- Patients should not currently be planned for a drug holiday within the next 12 months
- Patients should not have a stoma (This would invalidate the PRO-2 outcome measure)
- Patients should not currently be pregnant
- Patient currently receiving subcutaneous infliximab or vedolizumab
Key Trial Info
Start Date :
December 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT07175454
Start Date
December 1 2025
End Date
December 1 2027
Last Update
November 17 2025
Active Locations (1)
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1
The Royal Wolverhampton NHS Trust
Wolverhampton, United Kingdom, WV10 0QP