NCT01162473

Milk Oral Immunotherapy in Children to Treat Food Allergy

A Study of the Efficacy of Milk Oral Immunotherapy in Children

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Children's Hospital of Philadelphia · Academic / Other
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Milk Hypersensitivity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Milk Oral Immunotherapy	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.
DRUG	Milk Protein Powder	Milk protein powder will be administered in incremental doses during the desensitization protocol.
OTHER	Food Challenge

Timeline

• Start date: 2010-06-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2010-07-14
• Last updated: 2015-05-13
• Results posted: 2015-05-13

Locations

1 site across 1 country: United States