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 @ 11:24 PM
Ignite Modification Date:
2025-12-24 @ 11:24 PM
NCT ID:
NCT04777656
Eligibility Criteria:
Inclusion Criteria:
* Child/Adolescent aged 6-17 years with a confirmed diagnosis of CD (for at least 3 months) with an active disease (defined as: wPCDAI \>12.5 or CRP \> 2 times upper limit or calprotectin levels \>250µg/g if available) despite anti-inflammatory (5-ASA and derivates), corticosteroids, immunomodulator (thiopurines or methotrexate) and/or biologic therapy (anti-TNF, anti-integrin anti-IL23 antibodies)
* For girls of childbearing age: a negative pregnancy test, and use of an effective method of contraception (abstinence, oral contraceptives, intra-uterine device, diaphragm with spermicide and condom)
* Patient willing to comply with daily intake of an exclusion diet
* Informed and signed consent of parents
* Patient affiliated to social security (or health insurance)
Exclusion Criteria:
* Active perianal fistulizing disease
* Internal fistula or evidence of un-drained and un-controlled abscess/phlegmon
* Patient who require CD-related surgical therapy
* Patient with known allergy to cow milk's proteins
* Patient incapable to follow CDED for a prolonged period
* Pregnancy, breastfeeding
* Patient already included in an interventional study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
17 Years
Study:
NCT04777656
Study Brief:
Protocol Section:
NCT04777656