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 @ 10:09 PM
Ignite Modification Date:
2025-12-24 @ 10:09 PM
NCT ID:
NCT02213835
Eligibility Criteria:
Inclusion Criteria:
1. Children and adolescents eight to twenty one years old
2. Diagnosis of Ulcerative colitis or Crohn's Disease made by a primary gastroenterologist based upon history, physical exam, laboratory/radiological studies and gastrointestinal histology
3. Mild or moderate disease activity based upon PCDAI score (10-45) or PUCAI score (10-60)
4. Parent/guardian and child must be able to comprehend the consent and assent
5. Parent/guardian and participant must be able to attend study visits at baseline, and weeks +2, +4, +8, +12.
6. Patient must not have medication changes for his/her inflammatory bowel disease medications for at least 1 months, unless medically necessary.
Exclusion Criteria:
1. Severe disease with PCDAI \>45 or PUCAI \>60
2. Active or history of intraabdominal abscess, intraabdominal fistula, stricturing Crohn's disease
3. Other serious medical conditions such as neurological, liver, kidney, autoimmune or systemic disease.
4. Has begun TNF inhibitors within two months prior to study
5. Has had change of maintenance medication within the last month
6. Tobacco, alcohol or illicit drug abuse
7. Pregnant subject recipients will be excluded
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
21 Years
Study:
NCT02213835
Study Brief:
Protocol Section:
NCT02213835