Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
National Jewish Health
Age
3–21
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | The Utility of Food-Specific IgE Measured With the IMMULITE 2000 Assay to Predict Symptomatic Food Allergy