Egg Oral Immunotherapy (Egg OIT)

This study is ongoing, but not recruiting participants.

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: September 28, 2012

Last verified: September 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

January 6, 2008

Last Updated Date

September 28, 2012

Start Date ^ICMJE

February 2003

Estimated Primary Completion Date

July 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00597558 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Egg Oral Immunotherapy

Official Title ^ICMJE

Treatment of Egg Allergy in Children Through Oral Desensitization

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 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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Food Hypersensitivity

Intervention ^ICMJE

Drug: Egg white protein

Egg white protein powder

Study Arm (s)

Experimental: Egg white protein

Subjects, who are egg allergic, are given egg white protein for desensitization with the hypothesis they will develop tolerance.

Intervention: Drug: Egg white protein

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2014

Estimated Primary Completion Date

July 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

1 Year to 16 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00597558

Other Study ID Numbers ^ICMJE

5111, 5111

Has Data Monitoring Committee

Yes

Responsible Party

Wesley Burks, MD, University of North Carolina, Chapel Hill

Study Sponsor ^ICMJE

University of North Carolina, Chapel Hill

Collaborators ^ICMJE

University of Arkansas

Investigators ^ICMJE

Principal Investigator:

Wesley Burks, MD

University of North Carolina, Chapel Hill

Information Provided By

University of North Carolina, Chapel Hill

Verification Date

September 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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