Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-24 @ 4:37 PM
NCT ID:
NCT03958266
Eligibility Criteria:
Inclusion Criteria:
* • Any patient 16-80 years of age at inclusion
* Established diagnosis of IBD (including UC, CD, inflammatory bowel disease of uncertain aetiology (IBD-U) and inflammation of an ileo-anal pouch (pouchitis))
* for more than 6 months prior to enrolment
* Has a smart phone device with access to the Apple AppStore or Google Play Store
* On stable medication by which we mean
* No change in oral 5-ASA dose in the last 1 month. Note, addition of 'as required' topical 5-ASA therapy is permitted
* Any revent oral corticosteroids must have been finished within 4 weeks. Note
* No change in immunomodulator dose for 3 months
* No change in biologic (Adalimumab, Infliximab, Ustekinumab and Vedolizumab) regime for 8 weeks
* Must be able to comply with all study requirements for the duration of the study as outlined in the protocol.
* Must be able to understand and be willing to provide written informed consent
Exclusion Criteria:
* • Currently taking part in a clinical trial of an Investigation Medical Procedure
* Significant psychiatric morbidity
* Patients likely to change IBD team within the next 12 months
* Patients taking Cyclosporine or Tacrolimus
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
80 Years
Study:
NCT03958266
Study Brief:
Protocol Section:
NCT03958266