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

University of North Carolina (UNC)

Status

Completed

Conditions

Food Hypersensitivity

Treatments

Drug: Egg white protein

Study type

Interventional

Funder types

Other

Identifiers

NCT00597558

11-2299

Details and patient eligibility

About

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.

Full description

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.

Enrollment

13 patients

Sex

All

Ages

1 to 16 years old

Volunteers

No Healthy Volunteers

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