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

This study has been completed.
Sponsor:
Collaborator:
University of Arkansas
Information provided by (Responsible Party):
Wesley Burks, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00597558
First received: January 6, 2008
Last updated: April 8, 2016
Last verified: April 2016
  Purpose
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 Intervention
Food Hypersensitivity
Drug: Egg white protein

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Egg Allergy in Children Through Oral Desensitization (EGG OIT)

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Negative Double-blind, Placebo-controlled Food Challenge (DBPCFC) to Egg After Egg OIT Treatment [ Time Frame: End of the study ] [ Designated as safety issue: No ]
    Subjects on egg OIT will have a negative double-blind, placebo-controlled food challenge (DBPCFC) to egg when the IgE to egg is < 7 kU/L or 90% of entry level IgE or SPT <= 5mm.


Secondary Outcome Measures:
  • Subjects on OIT Will Have a Decrease in Wheal Size of an Egg Protein Skin Prick Test Placed at the End of the Study on OIT Compared With Wheal Size of Egg Protein Skin Test at Entry. [ Time Frame: End of the study ] [ Designated as safety issue: No ]
  • Subjects on OIT Will Have a Decrease in Serum CAP-FEIA to Egg Over the Course of the Study. [ Time Frame: End of the study ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: February 2003
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   1 Year to 16 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00597558

Locations
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
Investigators
Principal Investigator: Wesley Burks, MD University of North Carolina, Chapel Hill
  More Information

Publications:
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 
Study First Received: January 6, 2008
Results First Received: April 7, 2016
Last Updated: April 8, 2016
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No

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

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

ClinicalTrials.gov processed this record on December 08, 2016