NCT01489553

Egg Oral Immunotherapy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 9 (actual)
• Sponsor: Children's Hospital of Philadelphia · Academic / Other
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Egg Hypersensitivity

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-09-01
• Completion: 2013-10-01
• First posted: 2011-12-09
• Last updated: 2013-10-22