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

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.

Study Overview

• Status: Completed
• Conditions: Food Hypersensitivity
• Intervention / Treatment: Drug: Egg white protein

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • University of Arkansas
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: University of Arkansas
• Investigators: Principal Investigator: Wesley Burks, MD, University of North Carolina, Chapel Hill

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2003
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: January 6, 2008
• First Submitted That Met QC Criteria: January 15, 2008
• First Posted (Estimate): January 18, 2008

Study Record Updates

• Last Update Posted (Actual): March 26, 2018
• Last Update Submitted That Met QC Criteria: February 27, 2018
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Egg allergy
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Egg Hypersensitivity; Food Hypersensitivity
• Other Study ID Numbers: 11-2299

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO