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 @ 3:23 AM
Ignite Modification Date:
2025-12-25 @ 3:23 AM
NCT ID:
NCT00367705
Eligibility Criteria:
Inclusion Criteria:
1. Children aged 6 - 18 years
2. Previous diagnosis of Crohn's disease or newly diagnosed with symptoms for at least three months before recruitment to the study.The diagnosis of CD is established by:
1. history and symptoms of the disease
2. endoscopy/histology or radiology with negative stool culture.
3. Written informed consent by parent
4. PCDAI \> 12.5 and \< 30
5. Treatment with 5-ASA, budesonide and imuran/6MP daily provided that the dose has remained stable for the 4 weeks (corticosteroids) or 12 weeks (for imuran/6MP) prior to inclusion. Children treated with other medications (such as anti-TNF or antibiotics including ciprofloxacilin or metronidazole) cannot enter this study.
Exclusion Criteria:
1. Short bowel syndrome/ileostomy/abscess/fistula/small bowel obstruction/stenosis/stricture
2. Imminent surgery
3. Treatment with anti-TNF, systemic corticosteroids, ciprofloxacillin, metronidazole within 12 weeks of the start of the trial.
4. Participation in another clinical trial within the last 30 days.
5. Patients should not take antibiotics during the study.
6. Patients should not take opioids, cholestyramine, ursodeoxycholic acid during the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
18 Years
Study:
NCT00367705
Study Brief:
Protocol Section:
NCT00367705