Egg Oral Immunotherapy - Full Text View

Sponsors and Collaborators:	Duke University University of Arkansas
Information provided by:	Duke University
ClinicalTrials.gov Identifier:	NCT00597558

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	Other: Egg white protein

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Treatment of Egg Allergy in Children Through Oral Desensitization

Resource links provided by NLM:

MedlinePlus related topics: Allergy Food Allergy

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	12
Study Start Date:	February 2003
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Intervention Details:

Egg white protein powder

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
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 of 7 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

Exclusion Criteria:

History of anaphylaxis to egg
Medical history that would prevent an OFC or DBPCFC to egg
Unable to cooperate with challenge procedures or unable to be reached by telephone for follow-up

Contacts and Locations

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

Locations

United States, Arkansas
University of Arkansas
Little Rock, Arkansas, United States, 72202

Sponsors and Collaborators

Duke University

University of Arkansas

Investigators

Principal Investigator:

Wesley Burks, MD

Duke University

More Information

Publications:

Buchanan AD, Green TD, Jones SM, Scurlock AM, Christie L, Althage KA, Steele PH, Pons L, Helm RM, Lee LA, Burks AW. Egg oral immunotherapy in nonanaphylactic children with egg allergy. J Allergy Clin Immunol. 2007 Jan;119(1):199-205. Epub 2006 Oct 27.

Responsible Party:	Duke University Medical Center ( A. Wesley Burks, MD )
Study ID Numbers:	5111, 5111
Study First Received:	January 6, 2008
Last Updated:	August 25, 2008
ClinicalTrials.gov Identifier:	NCT00597558 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Duke University:

Egg allergy

Study placed in the following topic categories:

Food Hypersensitivity
Hypersensitivity
Hypersensitivity, Immediate
Egg Hypersensitivity

Additional relevant MeSH terms:

Hypersensitivity
Food Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on July 02, 2009