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 @ 2:55 AM
Ignite Modification Date:
2025-12-25 @ 2:55 AM
NCT ID:
NCT01950533
Eligibility Criteria:
Inclusion Criteria:
* Age 3 to 21 years of either sex and any race
* Physician-diagnosed food allergy or convincing clinical history of food allergy to milk, egg, and/or peanut AND a Skin prick test positive to milk, egg, and/or peanut (diameter of wheal \> 3 mm or greater than negative control) orOR a detectable serum food-specific IgE level (ImmunoCAP and/or IMMULITE \> 0.35 kUA/L) to milk, egg, and/or peanut
* If no history of clinical reactivity to milk, egg, or peanut, then a positive skin prick test to milk, egg, and/or peanut (diameter of wheal \> 3 mm or greater than negative control) OR a detectable serum food-specific IgE level within the previous 4 months to milk, egg, and/or peanut
* Written informed consent from parent/guardian and assent (when age appropriate).
* Willingness to submit specimen for laboratory serum IgE testing
Exclusion Criteria:
* Inability to discontinue antihistamines for skin prick testing and OFCs
* Current allergy to placebo ingredient (oat flour) OR reaction to any dose of placebo at the qualifying OFC
* FEV1 value \<80% predicted OR any clinical features of moderate or severe persistent asthma, as defined by the 2007 NHLBI guidelines table for classifying asthma baseline severity (Step 3 or above), at the time of entry into the study
* Use of , and \>high medium daily doses of inhaled corticosteroids, as defined by the 2007 NHLBI guidelines inhaled corticosteroid dosing table (500500 μg/day fluticasone or equivalents for an adult) or a long acting beta-agonist (LABA) to control asthma.
* Asthma requiring either:
\> 1 hospitalization in the past year for asthma or \> 1 ER visit in the past 6 months for asthma
* History of intubation due to allergies or asthma
* Use of steroid medications (IV, IM or oral) for asthma in the following manners:
* history of daily oral steroid dosing for \>1 month during the past year or
* burst or steroid course/burst in the past 3 months or
* \>2 burst oral steroid courses/bursts in the past year
* History of intubation due to allergies or asthma
* Life-threatening allergic reaction (e.gi.e., respiratory compromise, hypoxia, hypotension, use of epinephrine) to study food(s) (e.g., milk, egg, and/or peanut) within last 1 year
* Diagnosis of active eosinophilic gastrointestinal disease in the past year
* Severe or poorly controlled atopic dermatitis, as assessed by a three-item severity (TIS) score of 6 or greater (see Appendix I)
* Use of omalizumab or other non-traditional forms of allergen immunotherapy (e.g., oral or sublingual), immunomodulatory therapy (not including corticosteroids), or biologic therapy within the past year
* Uncontrolled hypertension
* Any use of β-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB) or calcium channel blockers
* Other significant medical conditions (e.g., liver, gastrointestinal, kidney, cardiovascular, pulmonary disease, or blood disorders), which, in the opinion of the Investigator, make the subject unsuitable for induction of food reactions
* Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
21 Years
Study:
NCT01950533
Study Brief:
Protocol Section:
NCT01950533