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 @ 2:12 AM
Ignite Modification Date:
2025-12-25 @ 2:12 AM
NCT ID:
NCT02738060
Eligibility Criteria:
Inclusion Criteria:
1. The patients' ages between 6 months to 18 years old.
2. Having positive histories of cow's milk allergy presenting by dermal, gastrointestinal, respiratory or systemic manifestations.
3. Confirmed cow's milk allergy by standard diagnostic tools such as skin prick test more than 8 millimeters or serum IgE levels higher than 5 KIU/L up to 2 years old and 15 KIU/L in other ages.
4. Cases who have tolerance to baked milk products confirmed by oral food challenge test.
Exclusion Criteria:
1. Ones with low serum IgE levels and negative skin prick test for milk products.
2. Ones with positive histories of unstable asthma.
3. Ones with eosinophilic gastrointestinal disorders.
4. Ones with history of allergy to baked milk products in last 6 months.
5. Ones with positive history of severe anaphylactic reaction to milk and its products in last 6 months.
6. Ones with positive allergy history to chicken egg or wheat.
7. Patients with celiac disease.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
18 Years
Study:
NCT02738060
Study Brief:
Protocol Section:
NCT02738060