Study of Milk Allergy and Tolerance in Children

Completed · Phase 2

Conditions studied: Food Hypersensitivity, Milk Hypersensitivity

In brief

The purpose of this study is to determine if children who are allergic to milk can increase tolerance through frequent dose-escalation every 6 months versus 12 months leading to eventual tolerance of less heated milk and ultimately unheated milk.

Key facts

Study ID

NCT00778258

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

170

Starts

2008-08-01

Expected to finish

2014-11-01

Last updated by the study team

2016-03-30

Who can join

Age: 4 and older, up to 10. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• One or more of the following inclusion criteria for enrollment in the study have to be met:
• Convincing history of an allergic reaction to milk or a positive double blind placebo controlled milk challenge (DBPCMC) within the past 2 years and either detectable milk immunoglobulin E (IgE) or positive prick skin test to milk OR
• Serum milk-IgE of high predictive value >14 kUa/L or prick skin test to milk > 10mm wheal within the past 6 months regardless of past clinical history of reactions OR
• Convincing history of an allergic reaction to milk or a positive DBPCMC more than 2 years ago and either a positive serum milk-IgE < 14 kUA/L or positive prick skin test to milk < 10 mm wheal within the past 6 months (eligible only for the active arm of the study and will undergo a reversed sequence of initial baked-milk challenges)

You may not qualify if…

• Inability or unwillingness of a participant to give written informed consent or to comply with study protocol

Where it is running

• Mount Sinai School of Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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