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 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT02201693
Eligibility Criteria:
Inclusion Criteria:
* 6-18 years
* Confirmed Crohn's disease (L1, L2, L3+/- L4a/b)
* new-onset disease or acute relapse treated with enteral nutrition
* responding to induction therapy with exclusive enteral nutrition with complete clinical remission at inclusion visit (wPCDAI\<12.5)
* completed cycle of induction therapy of at least 6 weeks (6-12 weeks)
* biological treatment by Remicade has to be stopped at least 8 weeks prior to inclusion
* "wash out" of corticosteroids, immunosuppressors and treatment by Humira of minimally 4 weeks prior to inclusion
* 5-ASA and derivates have to be stopped at least at screening visit
* Antibiotics must be stopped at least 2 weeks prior to inclusion
* Informed and signed consent
Exclusion Criteria:
* Patients with B2 or B3 disease behavior (intestinal/colonic stenosis (including ileo-caecal valve), intrabdominal abscess, fistulizing disease)
* Patients not in remission on induction therapy (wPCDAI\>12.5)
* Patients with isolated and severe perianal disease
* Patients requiring surgical therapy at inclusion
* Ongoing steroid medication
* Ongoing immunosuppressor or biologics therapy
* No informed consent
* Currently participating or having participated in another interventional clinical trial during the last 4 weeks prior to the beginning of this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
18 Years
Study:
NCT02201693
Study Brief:
Protocol Section:
NCT02201693