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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: University of North Carolina, Chapel Hill

Current Primary Outcome: 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.


Original Primary Outcome: Subjects on egg OIT will have a negative double-blind, placebo-controlled food challenge (DBPCFC) to egg when the IgE is < 2 kU/l. [ Time Frame: End of the study ]

Current Secondary Outcome:

  • 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.
  • 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


Original Secondary Outcome: 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 ]

Information By: University of North Carolina, Chapel Hill

Dates:
Date Received: January 6, 2008
Date Started: February 2003
Date Completion:
Last Updated: January 21, 2017
Last Verified: January 2017