Oral Immunotherapy for Childhood Egg Allergy

Completed · Phase 2 · Has a placebo group

Conditions studied: Hypersensitivity, Immediate Hypersensitivity, Food Hypersensitivity

In brief

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.

Key facts

Study ID

NCT00461097

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

55

Starts

2007-05-01

Expected to finish

2013-12-01

Last updated by the study team

2017-12-13

Who can join

Age: 5 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Arkansas Children's Hospital Research Institute — Little Rock, Arkansas, United States
• National Jewish Medical and Research Center — Denver, Colorado, United States
• Johns Hopkins University School of Medicine — Baltimore, Maryland, United States
• Mount Sinai School of Medicine — New York, New York, United States
• University of North Carolina — Chapel Hills, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.