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:
NCT03508193
Eligibility Criteria:
Inclusion Criteria:
1. Age 8 -21 years old
2. Diagnosis of Crohn's disease within 4 weeks of study entry
3. Active Crohn's disease, as defined by Pediatric Crohn's Disease Activity Index (PCDAI) ≥10.
4. Participant capable of giving informed consent, or if a minor the parent/guardian is capable of giving informed consent
Exclusion Criteria:
1. History of surgery for Crohn's disease
2. Perianal disease as part of Crohn's disease phenotype
3. Prior treatment with EEN or the specific carbohydrate for Crohn's disease
4. Prior treatment with any immunosuppressive medication (corticosteroids, anti-TNF-alpha agent, azathioprine, methotrexate, etc.)
5. Prior treatment with antibiotics for Crohn's disease
6. Known allergies to any of the food components in the smoothie
7. Admission to hospital due to severity of Crohn's disease and associated symptoms
8. Unwillingness to provide informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
21 Years
Study:
NCT03508193
Study Brief:
Protocol Section:
NCT03508193