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 @ 3:15 PM
Ignite Modification Date:
2025-12-24 @ 3:15 PM
NCT ID:
NCT06281392
Eligibility Criteria:
INCLUSION CRITERIA:
* Adults (age ≥18 years).
* Patients with IBD meeting the following criteria:
* Diagnosis of IBD confirmed by clinical and histological evidence.
* Disease extent (Montreal classification): 1) For Ulcerative Colitis (UC), Extensive colitis (E3): involvement proximal to the splenic flexure; or, Left-sided colitis (E2): involvement distal to the splenic flexure. 2) For Crohn's Disease (CD): Colon-only involvement (L2); or, Ileocolonic involvement (L3).
* Disease duration \> 7 years.
* Patients with concommitant Primary Sclerosing Cholangitis, regardless of the extent of colonic involvement and disease duration.
* Written consent from the patient to undergo colonoscopy (signed informed consent).
EXCLUSION CRITERIA:
* Personal history of colorectal cancer (CRC).
* Previous colectomy (partial or complete).
* Coagulopathy preventing biopsy or polypectomy/mucosal resection.
* Colonoscopy performed in the last 6 months.
* Pregnant or lactating women.
* Ulcerative colitis with involvement limited to the rectum or Proctitis (Montreal E1).
* Inadequate colonic preparation due to uncleavable fecal residue during colonoscopy: Boston Bowel Preparation Scale (BBPS) = 0 or 1 in any colon segment.
* Presence of inflammatory activity due to IBD on endoscopy:1) For UC: Endoscopic Mayo Score ≥ 2. 2) For CD: Simplified Endoscopic Activity Score (SES-CD) \> 5.
* Incomplete lower digestive endoscopy (failure to reach the cecum).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06281392
Study Brief:
Protocol Section:
NCT06281392