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 @ 10:31 PM
Ignite Modification Date:
2025-12-24 @ 10:31 PM
NCT ID:
NCT04079335
Eligibility Criteria:
Inclusion Criteria:
Patient with Crohn's Disease
1. Aged ≥18 years old
2. Confirmed diagnosis of ileo-colonic Crohn's disease according to established clinical, endoscopic and histologic criteria
3. History of at least one flare with symptoms that required intervention within 24 months before screening
4. Stable doses of immunosuppressive agents for at least 3 months if these agents are required
5. In clinical remission for at least 3 months, defined as Harvey Bradshaw Index (HBI) score \< 4
6. Written informed consent obtained
Patient with Ulcerative Colitis
1. Aged ≥18 years old
2. Have a confirmed diagnosis of ulcerative colitis according to established clinical, endoscopic and histologic criteria
3. History of at least one flare with symptoms that required intervention within 24 months before screening
4. On stable regimen of 5-ASA for at least 3 months
5. In clinical remission for at least 3 months defined as partial Mayo score ≤ 1
6. Written informed consent obtained
Exclusion Criteria:
1. Previous bowel surgery /stoma
2. On anti-TNF therapy
3. Malignant disease within 5 years
4. Use of probiotics, prebiotics or antibiotics in past 3 months
5. Terminal illness
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04079335
Study Brief:
Protocol Section:
NCT04079335