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

Food Hypersensitivity Clinical Trial

— EggOIT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00597558
• Other study ID #: 11-2299
• Status: Completed
• Phase: N/A
• First received: January 6, 2008
• Last updated: February 27, 2018
• Start date: February 2003
• Est. completion date: August 2014

Study information

• Verified date: January 2017
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Egg Hypersensitivity
• Food Hypersensitivity
• Hypersensitivity

Intervention

Drug:
• Egg white protein
Egg white protein powder

Locations

Country	Name	City	State
United States	UNC Chapel Hill	Chapel Hill	North Carolina
United States	University of Arkansas	Little Rock	Arkansas

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	University of Arkansas

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Epub 2006 Oct 27. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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