Partial hydrolyzed protein in cows milk protein allergy risk reduction.
- Conditions
- Cow's milk allergy, infants with CMA risk
- Registration Number
- NL-OMON24148
- Lead Sponsor
- aboratorios PiSa, MexicoIMSS Pachuca, Hidalgo, Mexico
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
1. Increased risk for allergy (mother, father, brother or sister with an allergic disease);
2. Full term newborn.
Exclusion Criteria
1. Severe acquired or congenital diseases;
2. Gestational age of less than 37 weeks;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Prevalence of cow's milk allergy, recorded on three-day diary allergy symptom, and confirmed by double blind challenge test;<br /><br>2. Tolerance of the formula by three-day questionaire and crying diaries on each time point;<br /><br>3. Antropometric measurements: Weight, length and head circumference, on each time point.
- Secondary Outcome Measures
Name Time Method The moment of onset of cow’s milk protein allergy during the intervention period for both of the formulae.