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Tolerance induction in cow's milk allergy

Completed
Conditions
Cow's milk allergy/ Cow's milk protein allergy
10001708
Registration Number
NL-OMON30721
Lead Sponsor
niversitair Medisch Centrum Utrecht
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
90
Inclusion Criteria

Child
Cow's milk allergy diagnosed by double blind, placebocontrolled randomised foodchallenge

Exclusion Criteria

immune-mediated disease

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The percentage of infants who develop tolerance at each outpatient day clinic<br /><br>visit (OPD), determined by a DBPCFC.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>The incidence and severity of asthma and allergic rhinitis.<br /><br>Serum Total IgE, IgG and IgG4 concentration.<br /><br>Newly acquired sensitizations, measured by specific IgE for the most prevalent<br /><br>food-and inhalant allergens.<br /><br>Peripheral blood derived T-cell phenotype, antigen-specific proliferation and<br /><br>cytokine production and/or expression of intracellular transcription factors<br /><br>specific for regulatory T-cells and cytokine production.<br /><br>Stool samples will be studied for identification and quantification of<br /><br>micro-organisms.</p><br>
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