Clinical trial NCT00597558: Treatment of Egg Allergy in Children Through Oral Desensitization (EGG OIT)
Official title: Treatment of Egg Allergy in Children Through Oral Desensitization (EGG OIT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Hypersensitivity
Keywords: Egg allergy
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: University of Arkansas
First posted: 2008-01-18
Enrollment: 13
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Double-blind, Placebo-controlled Food Challenge (DBPCFC) to Egg
timeFrame: 24-60 months
Secondary outcomes:
measure: Egg Protein Skin Prick Test After Egg OIT
timeFrame: 24-60 months
measure: Serum CAP-FEIA to Egg
timeFrame: 24-60 months
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas
state: Arkansas
city: Chapel Hill
country: United States
facility: UNC Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Wesley Burks, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Buchanan AD, Green TD, Jones SM, Scurlock AM, Christie L, Althage KA, Steele PH, Pons L, Helm RM, Lee LA, Burks AW. Egg oral immunotherapy in nonanaphylactic children with egg allergy. J Allergy Clin Immunol. 2007 Jan;119(1):199-205. doi: 10.1016/j.jaci.2006.09.016. Epub 2006 Oct 27.
citation: Vickery BP, Pons L, Kulis M, Steele P, Jones SM, Burks AW. Individualized IgE-based dosing of egg oral immunotherapy and the development of tolerance. Ann Allergy Asthma Immunol. 2010 Dec;105(6):444-50. doi: 10.1016/j.anai.2010.09.030.