Status:
COMPLETED
Oral Immunotherapy for Childhood Egg Allergy
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Consortium of Food Allergy Research
Conditions:
Hypersensitivity
Immediate Hypersensitivity
Eligibility:
All Genders
5-18 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine if oral immunotherapy (OIT) will desensitize a child with an allergy to egg and eventually lead to the development of tolerance to egg.
Detailed Description
In the United States, as many as 6% to 8% of children are affected by food allergy. In young children, allergic reactions to egg can range from mild rash to systemic anaphylaxis. The usual standard of...
Eligibility Criteria
Inclusion
- Convincing clinical history of egg allergy
- Age 6 to 18 years, with a serum IgE \[UniCAP\] to egg \> 5 kUA/L OR
- Age 5 to 6 years, with a serum IgE \[UniCAP\] to egg ≥ 12kUA/L
- Parent/guardian willing to provide informed consent
- Willing to use acceptable forms of contraception
Exclusion
- History of severe anaphylaxis to egg. More information on this criterion can be found in the protocol.
- Known allergy to corn
- Chronic disease requiring therapy (e.g., heart disease, diabetes). Participants who have asthma, atopic dermatitis, or rhinitis are not excluded.
- Participation in any interventional study for the treatment of food allergy in the 6 months prior to study entry
- Participant is on "build-up phase" of immunotherapy and has not reached maintenance dosing. Participants tolerating maintenance allergen immunotherapy are not excluded.
- Severe asthma, uncontrolled mild or moderate asthma. More information on this criterion can be found in the protocol.
- Inability to discontinue antihistamines for the initial day of escalation, skin testing, and OFC
- Omalizumab or other nontraditional forms of oral or sublingual allergen immunotherapy, immunomodulator therapy, or biologic therapy in the 12 months prior to study entry. Participants who have taken corticosteroids are not excluded.
- Investigational drugs 90 days prior to study entry or planned use of an investigational drug during the study period
- Pregnancy or breastfeeding
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00461097
Start Date
May 1 2007
End Date
December 1 2013
Last Update
December 13 2017
Active Locations (5)
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1
University of Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, United States, 72202
2
National Jewish Medical and Research Center
Denver, Colorado, United States, 80206
3
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21205
4
Mount Sinai School of Medicine
New York, New York, United States, 10029