Milk Allergy Clinical Trial
Official title:
Xolair (Omalizumab) Enhances Oral Tolerance Induction in Milk Allergic Children
This is a pilot feasibility study, using Xolair pretreatment for oral milk desensitization. The major assessment will be safety, and the investigators will evaluate for any type of reaction, including allergic reactions that occur during the course of the study.
Our hypothesis is that pretreatment with anti-IgE mAb will greatly reduce the side effects
and allergic reactions that occur during oral desensitization to foods and will enhance the
development of oral tolerance in patients with severe milk allergy. Once desensitized to
milk, children will be able to tolerate milk in a Double Blind Placebo Controlled Food
Challenge.
The study will also evaluate whether Xolair provides a robust durability of tolerance once
administration of Xolair is terminated. We will examine the specific immunological mechanisms
that mediate oral tolerance in children undergoing oral milk desensitization
The trial will be conducted in three parts: (1) pre-treatment with Xolair for 8 weeks, (2)
oral desensitization to cow's milk from weeks 9-16 and continued treatment with Xolair for 8
weeks, and (3) double blind placebo controlled food challenge to milk.
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