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 @ 3:10 AM
Ignite Modification Date:
2025-12-25 @ 3:10 AM
NCT ID:
NCT03980405
Eligibility Criteria:
Inclusion Criteria:
1. Informed consent
2. Established diagnosis of UC by the Paris classification and Revised Porto Criteria.
3. Age: 10 - 19 years (inclusive)
4. Mild to moderate active disease, 10 ≤ PUCAI ≤45
5. Extent E2-E4 by the Paris classification
6. Weight \>30 kg (ensures that patients who received 5ASA ≤2 grams are eligible)
7. Stable medication (IMM/ 5ASA) use or no change in medication use for the past 6 weeks. Patients who have received topical 5ASA therapy for \<10 days and are active may be included if topical therapy is stopped at enrolment.
8. Patients not receiving 5ASA or using 5ASA\<50mg/kg/day
Exclusion Criteria:
1. Any proven current infection such as positive stool culture, parasite or C. difficile.
2. Steroids (oral or intravenous) use in the past 3 months.
3. Patients who continue topical 5ASA or steroids after enrolment
4. Use of biologics in present or in past 6 months
5. Use of antibiotics for more than one week in the past 60 days
6. PUCAI \>45
7. Acute severe UC in the previous 12 months.
8. Current extra intestinal manifestation of UC.
9. Primary Sclerosing Cholangitis (PSC) or Liver disease
10. Pregnancy.
11. Vegans or patients unwilling or unable to consume eggs
12. Inflammatory Bowel Disease (IBD) unclassified
Exclusion criteria Comments:
1. Stool culture, parasite or C. difficile will only be measured if the patient has diarrhea.
2. Patients who have received treatment enemas for 3 weeks or less then 3 days and are active, can be included but must stop the enemas on the day of enrolment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
19 Years
Study:
NCT03980405
Study Brief:
Protocol Section:
NCT03980405