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:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07402135
Eligibility Criteria:
Inclusion Criteria:
1. Confirmed UC diagnosis ≥6 months.
2. Clinical remission: Partial Mayo Score (pMS) ≤2, with stool frequency and rectal bleeding subscores ≤1.
3. Endoscopic remission (MES ≤1) confirmed by colonoscopy within 12 weeks pre-screening.
4. Stable maintenance therapy (5-ASA, immunomodulators, biologics, or JAK inhibitors) ≥8 weeks.
5. Written informed consent.
Exclusion Criteria:
1. Indeterminate colitis or Crohn's disease.
2. History of toxic megacolon, symptomatic colonic stricture, or dysplasia. Prior colectomy.
3. Systemic/local corticosteroid use within 8 weeks.
4. Active gastrointestinal infection or chronic diarrhea from non-UC causes.
5. Pregnancy, lactation, or concurrent interventional trial participation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07402135
Study Brief:
Protocol Section:
NCT07402135