Egg Oral Immunotherapy
|ClinicalTrials.gov Identifier: NCT01489553|
Recruitment Status : Completed
First Posted : December 9, 2011
Last Update Posted : October 22, 2013
|Condition or disease|
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 Type :||Observational|
|Actual Enrollment :||9 participants|
|Official Title:||Egg Oral Immunotherapy|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||October 2013|
- Percentage of children completing desensitization [ Time Frame: Baseline & 12 months ]Evaluate proportion of subjects who successfully complete the food challenge to native egg upon completion of the desensitization protocol to baked egg.
- Change in Egg specific IgE values at the beginning and end of desensitization [ Time Frame: Baseline & 12 months ]Specific IgE values will be compared for egg at the beginning and the end of the desensitization protocol.
- Change in quality of life variables [ Time Frame: Baseline & 12 months ]Comparison of quality of life before and after desensitization through the completion of a voluntary and confidential survey.
- Number of participants with adverse events [ Time Frame: Baseline & 12 months ]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.
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01489553
|Principal Investigator:||Jonathan M. Spergel, MD, PhD||Children's Hospital of Philadelphia|
|Study Director:||Rushani W. Saltzman, MD||Children's Hospital of Philadelphia|