The Utility of Food-Specific IgE Measured With the IMMULITE 2000 Assay to Predict Symptomatic Food Allergy

Inclusion Criteria:

- Age 3 to 21 years of either sex and any race

- Physician-diagnosed food allergy orOR convincing clinical history of food allergy to
milk, egg, and/or peanut AND a sSkin 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 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 asthmaUse 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 ssteroid 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