Egg Hypersensitivity Clinical Trial
Official title:
Egg Oral Immunotherapy
For patients with Immunoglobulin E (IgE)-mediated food allergy, the current management includes identification of the causative food and avoidance. Egg allergy is among the most common causes of IgE-mediated food allergy in children, affecting approximately 1.6% of children (its prevalence is higher in children with atopic dermatitis or other food allergies). Given the prevalence of egg and the difficulty to avoid it in the diet, we aim to investigate the safety and efficacy of baked egg oral immunotherapy.
The primary objective is to study the efficacy of baked egg oral immunotherapy. The
secondary objectives are to determine the safety of allergen-specific immunotherapy for egg
allergy through ingestion of baked egg products and whether it will ultimately lead to a
desensitized state for native egg. We will also examine if quality of life is improved by
expansion of diets.
Subjects aged six to 17 years with a history of egg protein allergy will be recruited from
The Children's Hospital of Philadelphia (CHOP) Allergy practice (main campus and satellite
locations).
Prior to and after the desensitization to baked egg, we will conduct double blind
placebo-controlled food challenges to native egg protein. During the desensitization phase,
we will give increasing doses of baked egg (meringue cookie or equivalent) on a weekly
basis, as tolerated.
The primary endpoint of the study includes the percentage of subjects who can successfully
complete the food challenge to native egg once they have completed the desensitization
protocol to baked egg. Secondary outcome measures include egg-specific IgE, quality of life
before and after desensitization, and egg skin prick test size.
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Observational Model: Case-Only, Time Perspective: Prospective
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