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 @ 10:47 PM
Ignite Modification Date:
2025-12-24 @ 10:47 PM
NCT ID:
NCT05725369
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years old;
* Diagnosis of IBD (Ulcerative Colitis, Crohn's Disease or IBD-Unclassified) confirmed by clinical, endoscopic, and histological evidence prior to screening as per standard criteria;
* BMI ≥ 30 mg/kg2 or a BMI between 25 and 30 mg/kg2 and an increased risk of diabetes or cardiovascular disease;
* Patients that are or have been referred to the CLI;
* Oral informed consent must be obtained and documented in EPIC.
Exclusion Criteria:
* Serious underlying disease other than IBD that in the opinion of the investigator may interfere with the subject's ability to participate fully in the study or would compromise subject safety (such as major neurological disorders, certain orthopedic impairments or any unstable, uncontrolled or severe systemic medical disorder);
* If female, the subject is pregnant or lactating;
* Illiteracy (disability to read and understand Dutch).
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05725369
Study Brief:
Protocol Section:
NCT05725369