CAMEL.
Recruiting
- Registration Number
- NL-OMON28739
- Lead Sponsor
- Friesland Foods
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
1. Under 6 months of age;
2. Documented cow's milk allergy, judged by an elimination-challenge test (open) and re-elimination, in conformity with the guidelines of ESPGHAN (European Society for Pediatric Gastroenterology, Hepatology and Nutrition);
Exclusion Criteria
1. Breast-feeding during the study;
2. Age > 6 months;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Development of tolerance for cow's milk, observed by a challenge test (double blind) after 12 months of treatment.
- Secondary Outcome Measures
Name Time Method 1. The severity of cow milk allergy related features, namely variables onf physical inspection, as well as observed features by the parents in a questionnaire/diary;<br /><br>2. Assessment of skin features will be performed by the objective SCORAD, as a measure for the severity of atopic dermatitis;<br /><br>3. Need for medication;<br /><br>4. Quality of life, as judged by the parents and noted in a questionnaire/diary;<br /><br>5. Weight and height;<br /><br>6. Effects on immuno(dys)regulation; on sensibilisation, namely allergen-specific IgE and epitope-specific IgE, T-lymfocyte subsets, as measured by membrane markers, signal-transduction proteins related to immunomodulation, In-vitro allergen–stimulated T-lymphocyte activity with specific cytokine detection.