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Treatment of Egg Allergy in Children Through Oral Desensitization (EGG OIT) (EggOIT)

Primary Purpose

Food Hypersensitivity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Egg white protein
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Food Hypersensitivity focused on measuring Egg allergy

Eligibility Criteria

1 Year - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Between 1 to 16 years of age
  • Diagnosed egg allergy by CAP FEIA to egg of 5 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
  • All females of child bearing age must be using appropriate birth control

Exclusion Criteria:

  • History of anaphylaxis to egg
  • Medical history that would prevent a DBPCFC (double-blind placebo-controlled food challenge) to egg. The medical history that would prevent the DBPCFC to egg would be a prior history of an open egg challenge in which the patient experienced hypotension which required fluid resuscitation, respiratory compromise which necessitated ventilatory support, or poorly controlled asthma as evidenced by an FEV1 < 80% of predicted, or FEV1/FVC <75%, with or without controller medications
  • Unable to cooperate with challenge procedures or unable to be reached by telephone for follow-up
  • Diagnosed corn allergy

Sites / Locations

  • University of Arkansas
  • UNC Chapel Hill

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Egg white protein

Arm Description

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

Outcomes

Primary Outcome Measures

Double-blind, Placebo-controlled Food Challenge (DBPCFC) to Egg
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.

Secondary Outcome Measures

Egg Protein Skin Prick Test After Egg OIT
Wheal size on egg protein skin prick test at the end of egg OIT treatment compared with at baseline.
Serum CAP-FEIA to Egg
Measure of serum CAP-FEIA to egg from subjects on egg OIT after completion of treatment compared to baseline

Full Information

First Posted
January 6, 2008
Last Updated
February 27, 2018
Sponsor
University of North Carolina, Chapel Hill
Collaborators
University of Arkansas
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1. Study Identification

Unique Protocol Identification Number
NCT00597558
Brief Title
Treatment of Egg Allergy in Children Through Oral Desensitization (EGG OIT)
Acronym
EggOIT
Official Title
Treatment of Egg Allergy in Children Through Oral Desensitization (EGG OIT)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
University of Arkansas

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Hypersensitivity
Keywords
Egg allergy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Egg white protein
Arm Type
Experimental
Arm Description
Subjects, who are egg allergic, are given egg white protein for desensitization with the hypothesis they will develop tolerance.
Intervention Type
Drug
Intervention Name(s)
Egg white protein
Other Intervention Name(s)
Egg OIT
Intervention Description
Egg white protein powder
Primary Outcome Measure Information:
Title
Double-blind, Placebo-controlled Food Challenge (DBPCFC) to Egg
Description
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.
Time Frame
24-60 months
Secondary Outcome Measure Information:
Title
Egg Protein Skin Prick Test After Egg OIT
Description
Wheal size on egg protein skin prick test at the end of egg OIT treatment compared with at baseline.
Time Frame
24-60 months
Title
Serum CAP-FEIA to Egg
Description
Measure of serum CAP-FEIA to egg from subjects on egg OIT after completion of treatment compared to baseline
Time Frame
24-60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Between 1 to 16 years of age Diagnosed egg allergy by CAP FEIA to egg of 5 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 All females of child bearing age must be using appropriate birth control Exclusion Criteria: History of anaphylaxis to egg Medical history that would prevent a DBPCFC (double-blind placebo-controlled food challenge) to egg. The medical history that would prevent the DBPCFC to egg would be a prior history of an open egg challenge in which the patient experienced hypotension which required fluid resuscitation, respiratory compromise which necessitated ventilatory support, or poorly controlled asthma as evidenced by an FEV1 < 80% of predicted, or FEV1/FVC <75%, with or without controller medications Unable to cooperate with challenge procedures or unable to be reached by telephone for follow-up Diagnosed corn allergy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wesley Burks, MD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
UNC Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17208602
Citation
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. doi: 10.1016/j.jaci.2006.09.016. Epub 2006 Oct 27.
Results Reference
result
PubMed Identifier
21130382
Citation
Vickery BP, Pons L, Kulis M, Steele P, Jones SM, Burks AW. Individualized IgE-based dosing of egg oral immunotherapy and the development of tolerance. Ann Allergy Asthma Immunol. 2010 Dec;105(6):444-50. doi: 10.1016/j.anai.2010.09.030.
Results Reference
result

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

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