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 @ 3:04 AM
Ignite Modification Date:
2025-12-25 @ 3:04 AM
NCT ID:
NCT02345733
Eligibility Criteria:
Inclusion Criteria:
1. Informed consent
2. Established diagnosis of UC.
3. Age: 8 - 19 years ( inclusive)
4. Mild to moderate active disease, 10 ≤ PUCAI ≤45.
5. Stable medication (IMM/ 5ASA) use for the past 6 weeks. Patients who have received topical 5ASA therapy for \<7 days and are active may be included if topical therapy is stopped at enrolment
Exclusion Criteria:
Exclusion criteria:
1. Any proven current infection such as positive stool culture, parasite or C. difficile.
2. Antibiotic or Steroids use in the past 2 weeks.
3. PUCAI \>45
4. Acute severe UC in the previous 12 months.
5. Current Extra intestinal manifestation of UC.
6. PSC or Liver disease
7. Pregnancy.
8. Allergy to one of the antibiotics or age \<11 will exclude patients from entering the antibiotic arm
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
19 Years
Study:
NCT02345733
Study Brief:
Protocol Section:
NCT02345733