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Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT01489553
Study type Observational
Source Children's Hospital of Philadelphia
Contact
Status Completed
Phase N/A
Start date January 2012
Completion date October 2013

See also
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Completed NCT00356174 - An Observational Study of Childhood Food Allergy N/A
Active, not recruiting NCT02487420 - Gradual Egg-tolerance Induction in Hen's Egg Allergic Children N/A
Completed NCT01379651 - Time-limited Specific Oral Tolerance Induction in Children With Severe Egg Allergy Phase 1/Phase 2
Active, not recruiting NCT04677790 - Gradual Egg-tolerance Induction in Hen's Egg Allergic Children Who Tolerate Baked Egg (TETI-II Study) N/A