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The Safety and Efficacy of Sublingual/Oral Immunotherapy for the Treatment of Milk Protein Allergy

NCT00732654 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-05-15

Study results available
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Summary

The purpose of this study is to determine if small oral and sublingual doses of milk protein are safe and effective in decreasing sensitivity to cow's milk in allergic children.

Conditions

  • Milk Allergy

Interventions

DRUG

Milk Protein Extract Immunotherapy goal of 4mg/day

Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.

DRUG

Milk Protein Extract Immunotherapy goal of 7mg/day

Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years.

DRUG

Milk Powder Immunotherapy goal dose 2000 mg/day

Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years.

DRUG

Milk Powder Immunotherapy goal dose 1000mg/day

Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years.

Sponsors & Collaborators

Principal Investigators

  • Robert Wood, MD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2010-06-30
Completion
2012-06-30

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT00732654 on ClinicalTrials.gov