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:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-25 @ 2:10 AM
NCT ID:
NCT05230160
Eligibility Criteria:
Inclusion Criteria:
1. ≥ 18 to ≤ 75 years of age;
2. ileocolonic or colonic CD in clinical remission diagnosed through conventional definitions with a Harvey Bradshaw Index (HBI) \< 5 within 3 months of recruitment;
3. presence of inflammation using an FCP ≥ 250 µg/g or a CRP ≥ 5 mg/L;
4. stable dosing of biologic agents and/or immunomodulators and/or oral or rectal 5-ASA, and no changes to medical management (including corticosteroid exposure) for at least 3 months prior to recruitment
5. presence of overweight or obesity with BMI \> 25 and a PG-SGA of class A.
Exclusion Criteria:
1. upper gastrointestinal involvement CD, fistulizing disease;
2. documented strictures based on sonographic findings or colonoscopy within the last year;
3. \> 1 small bowel resection;
4. colectomy;
5. presence of an ostomy;
6. antibiotic use in past 3-months;
7. pregnancy;
8. corticosteroids in the last 3 months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05230160
Study Brief:
Protocol Section:
NCT05230160