NCT01489553

Completed

Egg Oral Immunotherapy

Children's Hospital of Philadelphia Source

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Other study identifiers

Sponsor study identifier

IRB 11-008294

Study Type

observational

Actual enrollment (reported)

9

Locations

0 countries

Sites

N/A

Timeline

Study Start

January 2012

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

September 2013

Actual (reported)

Study Completion

October 2013

Actual (reported)

Brief Summary

For patients with Immunoglobulin E (IgE)-mediated food allergy, the current management includes identification of the causative food and avoidance. Egg allergy is among the most common causes of IgE-mediated food allergy in children, affecting approximately 1.6% of children (its prevalence is higher in children with atopic dermatitis or other food allergies). Given the prevalence of egg and the difficulty to avoid it in the diet, we aim to investigate the safety and efficacy of baked egg oral immunotherapy.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 9 participants
Study completion date: October 2013
Actual (reported)
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
December 8, 2011
Actual (reported)
First Posted
December 9, 2011
Actual (reported)
Study Start
January 2012
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
September 2013
Actual (reported)
Study Completion
October 2013
Actual (reported)

Last Updated: October 22, 2013
Status Verified: October 2012
Last Update Submitted: October 21, 2013

Conditions

Egg Hypersensitivity

Keywords

Egg hypersensitivityegg allergyegg protein allergy

Outcome Measures

Primary Outcomes (1)

Percentage of children completing desensitization
Evaluate proportion of subjects who successfully complete the food challenge to native egg upon completion of the desensitization protocol to baked egg.
Baseline & 12 months

Secondary Outcomes (3)

Change in Egg specific IgE values at the beginning and end of desensitization
Baseline & 12 months
Change in quality of life variables
Baseline & 12 months
Number of participants with adverse events
Baseline & 12 months

Eligibility Criteria

Age6 Years - 17 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

Sampling MethodNon-Probability Sample

Study Population

outpatient Allergy patients followed at The Children's Hospital of Philadelphia

You may qualify if:

Subjects must be age six to 17 years and have a history of egg allergy. Subjects shall maintain strict avoidance of consumption of all egg protein containing foods.

Sponsors & Collaborators

Children's Hospital of Philadelphia
Otherlead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Immunocap testing (bloodwork) will be performed prior to and upon completion of the desensitization protocol. This testing is considered standard of care in the management of food allergies.

MeSH Terms

Conditions

Egg Hypersensitivity

Condition Hierarchy (Ancestors)

Food HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

Jonathan M. Spergel, MD, PhD
Children's Hospital of Philadelphia
PRINCIPAL INVESTIGATOR
Rushani W. Saltzman, MD
Children's Hospital of Philadelphia
STUDY DIRECTOR

Enrollment

9 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: CASE ONLY
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 8, 2011

First Posted

December 9, 2011

Study Start

January 2012

Date type not reported

This date has not been verified as actual or estimated.

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Subjects will have a history (within the past six months) of a positive skin prick test to egg extract or an immunocap IgE level greater than 0.35 kU/L, and a positive allergic reaction history to egg within the past 12 months.

a. Subjects will be accepted to the study if they have had a positive food challenge conducted at CHOP in the three months prior to the start of the study.

Subjects must be in good health, as determined by medical history and physical examination performed by a study physician.

Females of childbearing potential must be using an effective method of contraception, including abstinence, and agree to continue to practice an acceptable method of contraception for the duration of their participation in the study.

If a positive pregnancy test was obtained during the study, the subject will be asked to withdraw from the study.

Informed consent of parent or legal guardian is required.

You may not qualify if:

Subjects will be excluded from the study if they meet any one of the following criteria:
Ability to tolerate baked goods containing egg or the ability to tolerate a serving size of egg (6.3 grams of egg protein.)
Pregnancy.
A history of food protein induced enterocolitis syndrome to egg.
A history of eosinophilic esophagitis, where egg has been identified as a causative food.
A history of anaphylaxis requiring overnight hospitalization.
A history of intubation related to asthma and/or a history of an intensive care unit admission for asthma management.
A current diagnosis of severe persistent asthma \[FEV1 (forced expiratory volume in 1 second) \< 60% of predicted, as defined by NHLBI (National Heart, Lung, and Blood Institute) guidelines, despite current therapy\].
A current diagnosis of severe atopic dermatitis.
A serious chronic medical condition, including neurologic, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease.
Use of oral or injection steroids within one month of protocol initial visit.
a. Should it become necessary for a subject to be on systemic corticosteroids while on the study, the subject will either be withdrawn from the study or the use of corticosteroids during the study will be taken into account during data analysis. The PI and lead investigators will make that decision based on the individual case.
An acute illness within one week prior to the first dose of oral immunotherapy.
Use of antihistamines within three days prior to Double blind placebo-controlled food challenge (DBPCFC).
Use of chronic immunomodulatory therapy.
+4 more criteria

Contact the study team to confirm eligibility.

Primary Completion

September 2013

Actual (reported)

Study Completion

October 2013

Actual (reported)

Last Updated

October 22, 2013

Record last verified: 2012-10

Source record

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Registry identifier: NCT01489553
Data provider: ClinicalTrials.gov
Source updated: 2013-10-22
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:40:06 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record