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 @ 2:29 PM
Ignite Modification Date:
2025-12-24 @ 2:29 PM
NCT ID:
NCT02727959
Eligibility Criteria:
Inclusion Criteria:
Ulcerative colitis:
Diagnostic criteria (at least three out of four criteria present):
1. A history of diarrhea and/or pus in stools for more than 4weeks or repeated episodes.
2. Macroscopic appearance at endoscopy of continuous mucosal inflammation affecting the rectum in continuity with some or the entire colon.
3. Microscopic features on biopsy compatible with UC,
4. No suspicion of CD on small bowel X-ray, ileocolonoscopy or biopsy.
Crohn's disease:
Diagnostic criteria (at least two of four criteria present):
1. History of abdominal pain, weight loss and/or diarrhea for more than three months.
2. Characteristic endoscopic findings of ulceration (aphthous lesions, snail track ulceration) or cobble stoning or radiological features of stricture or cobble stoning.
3. Histopathology consistent with Crohn's disease (epitheloid granuloma of Langerhans type or transmural discontinuous focal or patchy inflammation).
4. Fistula and/or abscess in relation to affected bowel segments.
Inflammatory bowel disease, type unclassified (IBDU) :
Patients with evidence on clinical and endoscopic grounds for chronic inflammatory bowel disease affecting the colon, without small bowel involvement, and no definitive histological or other evidence to favor either CD or UC.
Pediatric patients:
Will be diagnosed according to the Porto-criteria and defined as:
Pediatric onset IBD ≤ 16 years Early Onset IBD (EOIBD) \< 10 years Very Early Onset IBD (VEOIBD) \< 6 years Infantile (and toddler) IBD \< 2 years Neonatal IBD \< 28 days
Exclusion criteria:
* Other causes of acute or chronic bowel inflammation must be excluded, i.e. infectious colitis, radiation colitis, diversion colitis, solitary rectal ulcer syndrome, graft versus host disease, diverticular colitis, medication associated colitis, ischemic colitis, microscopic colitis, enema associated colitis.
* Refusal or not able to give informed consent
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
100 Years
Study:
NCT02727959
Study Brief:
Protocol Section:
NCT02727959