At a glance
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A Study of the Efficacy of Milk Oral Immunotherapy in Children
In Brief
A Early Phase 1 clinical trial evaluating Milk Oral Immunotherapy, Milk Protein Powder, and 1 other intervention for Milk Hypersensitivity. Completed, enrolled 25 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Subjects will participate in a desensitization protocol over the course of 13 weeks to reach a goal maintenance dose of 8 ounces of cow's milk. Once reaching maintenance, subjects will continue on this dose for 12 additional weeks.
Milk protein powder will be administered in incremental doses during the desensitization protocol.