Status:
COMPLETED
Study of Milk Allergy and Tolerance in Children
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Asthma and Allergic Diseases Cooperative Research Centers
Conditions:
Food Hypersensitivity
Milk Hypersensitivity
Eligibility:
All Genders
4-10 years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
Milk is among the most common food allergens in infants and children. The majority of children outgrow their milk allergies; however, the exact mechanisms by which food tolerance is achieved are unkno...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- Inability or unwillingness of a participant to give written informed consent or to comply with study protocol
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT00778258
Start Date
August 1 2008
End Date
November 1 2014
Last Update
March 30 2016
Active Locations (1)
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1
Mount Sinai School of Medicine
New York, New York, United States, 10029