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 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 1:11 AM
NCT ID:
NCT03352193
Eligibility Criteria:
Inclusion Criteria:
1. Age 2-16 years
2. Personal history of IgE-mediated allergy to wheat with unequivocal allergic reaction one year before study entry, and
1. Positive SPT in wheat (\> 3 mm), and/or
2. Wheat specific IgE f4 \> 0.35 kUa/L, and
3. A positive Oral Food Challenge (OFC) to wheat, with the exception of patients who report a recent reaction (\< 3 months before study entry) after the consumption of wheat products
3. Signed written consent form of the parents.
Exclusion Criteria:
1. Severe persistent or uncontrolled bronchial asthma or other lung disease (other than asthma), and/or
2. Recent personal history (over the past 12 months) of severe anaphylactic reaction following wheat consumption, for which Intensive Care Unit (ICU) hospitalization was required, and/or
3. Patients on specific immunotherapy, subcutaneous (SCIT) or sublingual (SLIT) or any other form of current immunotherapy or treatment with other biological agents, and/or
4. Personal history of anaphylaxis due to wheat-dependent exercise induced anaphylaxis, and/or
5. Patients with celiac disease or diagnosis other than IgE-mediated wheat allergy (eg eosinophilic gastrointestinal diseases), and/or
6. Patients with cardiovascular disease or other significant systemic disease, and/or
7. Patients presenting severe anaphylactic reaction to very low doses of wheat (eg. after administration of the 1st or 2nd dose during the baseline OFC).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
16 Years
Study:
NCT03352193
Study Brief:
Protocol Section:
NCT03352193