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Baked Egg or Egg Oral Immunotherapy for Children With Egg Allergy

NCT01846208 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2019-07-26

Study results available
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Summary

The purpose of this study is to compare Baked Egg vs. Egg Oral Immunotherapy for inducing sustained unresponsiveness to egg exposure in children.

Conditions

Interventions

DRUG

Egg Oral Immunotherapy

Commercially available egg white solid dispensed by the central manufacturer. Study product will be dispensed in vials for low doses, capsules for mid-range doses, and bulk powder with dosing scoops for the higher doses.

DRUG

Baked Egg

Predetermined food substances with known amounts of Baked Egg (egg protein) with standardized dosing/consumption instructions.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Consortium of Food Allergy Research

    collaborator OTHER

  • Hugh A Sampson, MD

    lead OTHER

Principal Investigators

  • Hugh A Sampson, MD · Icahn School of Medicine at Mount Sinai

  • Robert Wood, MD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2017-09-28
Completion
2018-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01846208 on ClinicalTrials.gov