NCT00597558

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 18, 2008

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

May 16, 2016

Completed
Last Updated

March 26, 2018

Status Verified

January 1, 2017

Enrollment Period

11.5 years

First QC Date

January 6, 2008

Results QC Date

April 7, 2016

Last Update Submit

February 27, 2018

Conditions

Food Hypersensitivity

Keywords

Egg allergy

Outcome Measures

Primary Outcomes (1)

  • 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.

    24-60 months

Secondary Outcomes (2)

  • Egg Protein Skin Prick Test After Egg OIT

    24-60 months

  • Serum CAP-FEIA to Egg

    24-60 months

Study Arms (1)

Egg white protein

EXPERIMENTAL

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

Drug: Egg white protein

Interventions

Egg white proteinDRUG

Egg white protein powder

Also known as: Egg OIT
Egg white protein

Eligibility Criteria

Age1 Year - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Arkansas

Little Rock, Arkansas, 72202, United States

Location

UNC Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (2)

  • 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.

    PMID: 17208602RESULT

  • 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.

    PMID: 21130382RESULT

MeSH Terms

Conditions

Food HypersensitivityEgg Hypersensitivity

Interventions

Egg Proteins

Condition Hierarchy (Ancestors)

Hypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

ProteinsAmino Acids, Peptides, and Proteins

Limitations and Caveats

Endpoints were based on reaching certain lab criteria and thus the time on treatment varied from 24-60 months.

Results Point of Contact

Title
Dr. Edwin Kim, Director
Organization
University of North Carolina at Chapel Hill
edwinkim@email.unc.edu
919-843-9087

Study Officials

  • Wesley Burks, MD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2008

First Posted

January 18, 2008

Study Start

February 1, 2003

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

March 26, 2018

Results First Posted

May 16, 2016

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

US(2)