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



Status:Completed
Conditions:Food Studies, Neurology
Therapuetic Areas:Neurology, Pharmacology / Toxicology
Healthy:No
Age Range:1 - 16
Updated:4/17/2018
Start Date:February 2003
End Date:August 2014

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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.

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.

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
We found this trial at
2
sites
CHapel Hill, North Carolina 27599
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CHapel Hill, NC
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Little Rock, Arkansas 72202
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Little Rock, AR
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