Treatment of Egg Allergy in Children Through Oral Desensitization (EGG OIT)

Study Overview
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Brief Summary
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The purpose of this study is to determine if children with egg allergy can be desensitized to egg protein and if this desensitization can help them outgrow their egg allergy at an earlier time than normal. Our hypothesis is that children with egg allergy can be orally desensitized to egg protein and that this desensitization will help them outgrow their egg allergy at an earlier time than normal.

Detailed Description
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Egg allergy in children under 5 years of age is extremely common. Egg, along with milk and peanuts, cause 80% of the food allergy reactions in children in the United States. Children have allergic reactions to egg ranging from mild urticaria to systemic anaphylaxis. The current therapy for children with egg allergy is to place the child on an egg-free diet until the allergy is outgrown. Because egg protein is a part of a significant number of processed foods it is difficult to totally avoid all egg proteins. Accidental ingestions leading to reactions to egg can occur with a bite of a cookie ( 70 mg of egg protein) or a bite of a cake ( 55 mg of egg protein). Children typically do not outgrow their egg allergy for several years. Therefore it would be helpful if a specific form of therapy would make children outgrow their allergic reactions to egg sooner. Egg protein is given to children in this study in small increasing amounts to desensitize them to the egg protein with the goal of helping them to outgrow their allergy.

Official Title
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Treatment of Egg Allergy in Children Through Oral Desensitization (EGG OIT)

Conditions
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Food Hypersensitivity

Intervention / Treatment
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* Drug: Egg white protein


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 1 to 16 years of age Diagnosed egg allergy by CAP FEIA to egg of 5 kU/l or greater (2 kU/l or greater if 2 years old or less) or have had a positive allergic reaction to egg within 6 months. Having eaten egg in his/her diet prior to diagnosis A family that will be able to be compliant with all study visits All females of child bearing age must be using appropriate birth control Exclusion Criteria: History of anaphylaxis to egg Medical history that would prevent a DBPCFC (double-blind placebo-controlled food challenge) to egg. The medical history that would prevent the DBPCFC to egg would be a prior history of an open egg challenge in which the patient experienced hypotension which required fluid resuscitation, respiratory compromise which necessitated ventilatory support, or poorly controlled asthma as evidenced by an FEV1 < 80% of predicted, or FEV1/FVC <75%, with or without controller medications Unable to cooperate with challenge procedures or unable to be reached by telephone for follow-up Diagnosed corn allergy

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Egg white protein<br>Subjects, who are egg allergic, are given egg white protein for desensitization with the hypothesis they will develop tolerance. | Drug: Egg white protein<br>* Egg white protein powder<br>* Other names: Egg OIT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Double-blind, Placebo-controlled Food Challenge (DBPCFC) to Egg | Subjects will have a double-blind, placebo-controlled food challenge (DBPCFC) to egg after at least 24 months of egg OIT when the IgE to egg is < 7 kU/L or 90% of entry level IgE or SPT <= 5mm with a maximum treatment period of 60 months. | 24-60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Egg Protein Skin Prick Test After Egg OIT | Wheal size on egg protein skin prick test at the end of egg OIT treatment compared with at baseline. | 24-60 months | 
| Serum CAP-FEIA to Egg | Measure of serum CAP-FEIA to egg from subjects on egg OIT after completion of treatment compared to baseline | 24-60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Egg allergy