Milk Hypersensitivity Clinical Trial
Official title:
A Study of the Efficacy of Milk Oral Immunotherapy in Children
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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