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 @ 3:18 PM
Ignite Modification Date:
2025-12-24 @ 3:18 PM
NCT ID:
NCT01980992
Eligibility Criteria:
Inclusion Criteria:
* Age 4-30 years either sex, any race, any ethnicity
* Positive Prick Skin Test to wheat greater than 3mm compared to control and/or a wheat specific IgE \>= 0.35 kUA/L
* Positive baseline challenge to wheat (\<= 1923 mg of vital wheat gluten)
* Written informed consent from subject and/or parent/guardian
* Written assent from all subjects as appropriate
* All females of child bearing age must be using appropriate birth control
Exclusion Criteria:
* History of anaphylaxis to wheat resulting in hypotension, neurological compromise or mechanical ventilation
* Known allergy to corn
* Known celiac disease
* Chronic disease (other than asthma, atopic dermatitis, rhinitis) requiring therapy (e.g., heart disease, diabetes)
* Active eosinophilic gastrointestinal disease in the past two years
* Participation in any interventional study for the treatment of food allergy in the past 6 months
* Subject is on "build-up phase" of immunotherapy (i.e., has not reached maintenance dosing). Subjects tolerating maintenance allergen immunotherapy can be enrolled.
* Severe asthma, uncontrolled mild or moderate asthma. More information on this criterion can be found in the protocol.
* A burst of oral, IM or IV steroids of more than 2 days for an indication other than asthma in the past 1 month
* Inability to discontinue antihistamines for initial day escalation, skin testing or OFC
* Use of omalizumab or other non-traditional forms of allergen immunotherapy or immunomodulator therapy (not including corticosteroids) or biologic therapy within the past year
* Use of beta-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB) or calcium channel blockers
* Use of investigational drug within 90 days or plan to use investigational drug during the study period
* Pregnancy or lactation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
30 Years
Study:
NCT01980992
Study Brief:
Protocol Section:
NCT01980992