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 @ 5:04 AM
Ignite Modification Date:
2025-12-25 @ 5:04 AM
NCT ID:
NCT04223518
Eligibility Criteria:
Inclusion Criteria:
* Pediatric patients, ages 6-30 years diagnosed with inflammatory bowel disease (UC/Crohn's disease) based on the pediatric ulcerative colitis activity index/ short pediatric Crohn's disease activity index for children and Harvey Bradshaw Index/SCCAI for young adults
Exclusion Criteria:
* Patients with severe illness requiring inpatient admission
* Patients with known allergy to beef or beef products, sunflower lecithin and dextrose
* Patients with liver function tests elevated to more than 3 times the upper limit of normal
* Pregnancy or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
30 Years
Study:
NCT04223518
Study Brief:
Protocol Section:
NCT04223518