Clinical Trial: Milk Oral Immunotherapy in Children to Treat Food Allergy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Study of the Efficacy of Milk Oral Immunotherapy in Children

Brief Summary:

Background and Rationale

For patients with Immunoglobulin E (IgE)-mediated food allergy, the current management includes identification of the causative food and avoidance. Specifically, among young children, cow's milk allergy is the most common food allergy, occurring in as many as 2-3%. Given the prevalence of milk and the difficulty to avoid it in the diet, the investigators aim to investigate the safety and efficacy of oral immunotherapy for cow's milk allergy.

Main Objective

The primary objective is to study the efficacy of milk oral immunotherapy.

Target Population

Children aged six to 17 years with a history of cow's milk allergy will be recruited from The Children's Hospital of Philadelphia Allergy clinical offices for the investigators study.


Detailed Summary:

Primary Study Interventions

Prior to and after the desensitization, we will conduct double-blind placebo controlled food challenges to cow's milk protein. During the desensitization phase, we will give increasing doses of cow's milk protein by mouth on a weekly basis, as tolerated. The desensitization protocol starts with dilutional doses of milk and build up to a goal of 8 ounces of cow's milk.

Main Study Outcome Measure

The percentage of children completing the desensitization protocol in each study group will be the primary outcome measure.


Sponsor: Children's Hospital of Philadelphia

Current Primary Outcome: Number of Subjects Who Completed Desensitization Protocol [ Time Frame: 1 year ]

Subjects who withdrew prior to completing the desensitization protocol and those who experienced anaphylaxis during the desensitization protocol (i.e., were unable to complete the protocol) were considered to be "treatment failures". Subjects who completed the desensitization protocol were considered to be "treatment successes".


Original Primary Outcome: The percentage of children completing desensitization in each study group will be the primary outcome measure. [ Time Frame: 1 year ]

Current Secondary Outcome:

Original Secondary Outcome:

  • A secondary outcome measure is the comparison of specific IgE values for milk between the beginning and end of the desensitization protocol. [ Time Frame: 1 year ]
  • Another secondary outcome measure includes the comparison of quality of life before and after desensitization. [ Time Frame: 1 year ]
  • Another secondary outcome measure includes the comparison of skin prick test for milk extract size before and after desensitization [ Time Frame: 1 year ]
  • Another secondary outcome measure includes the percent change in invariant NKT cells and their cytokine expression between the immediate and delayed desensitization groups. [ Time Frame: 1 year ]


Information By: Children's Hospital of Philadelphia

Dates:
Date Received: July 13, 2010
Date Started: June 2010
Date Completion:
Last Updated: May 11, 2015
Last Verified: May 2015