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

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ClinicalTrials.gov Identifier: NCT00597558
Recruitment Status : Completed
First Posted : January 18, 2008
Results First Posted : May 16, 2016
Last Update Posted : March 7, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Food Hypersensitivity 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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Egg Allergy in Children Through Oral Desensitization (EGG OIT)
Study Start Date : February 2003
Primary Completion Date : August 2014
Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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 Name: Egg OIT

Outcome Measures

Primary Outcome Measures :
  1. Double-blind, Placebo-controlled Food Challenge (DBPCFC) to Egg [ Time Frame: 24-60 months ]
    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.

Secondary Outcome Measures :
  1. Egg Protein Skin Prick Test After Egg OIT [ Time Frame: 24-60 months ]
    Wheal size on egg protein skin prick test at the end of egg OIT treatment compared with at baseline.

  2. Serum CAP-FEIA to Egg [ Time Frame: 24-60 months ]
    Measure of serum CAP-FEIA to egg from subjects on egg OIT after completion of treatment compared to baseline

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00597558

United States, Arkansas
University of Arkansas
Little Rock, Arkansas, United States, 72202
United States, North Carolina
UNC Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
University of Arkansas
Principal Investigator: Wesley Burks, MD University of North Carolina, Chapel Hill
More Information

Responsible Party: Wesley Burks, MD, Chairman, Department of Pediatrics, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00597558     History of Changes
Other Study ID Numbers: 11-2299
First Posted: January 18, 2008    Key Record Dates
Results First Posted: May 16, 2016
Last Update Posted: March 7, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Wesley Burks, MD, University of North Carolina, Chapel Hill:
Egg allergy

Additional relevant MeSH terms:
Food Hypersensitivity
Egg Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate