Hypoallergenicity of an extensively hydrolyzed whey protein infant formula in children with cow's milk allergy.
Suspended
- Conditions
- Cow's milk allergy (CMA).
- Registration Number
- NL-OMON25061
- Lead Sponsor
- Danone Research - Centre for Specialised Nutrition
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 47
Inclusion Criteria
1. Children with cow's milk allergy, diagnosed by a double-blind, placebo-controlled food challenge (DBPCFC) within 4 weeks prior to study start;
2. Aged from birth to 24 months;
Exclusion Criteria
1. Children consuming mother's milk at the time of inclusion and during the trial;
2. Intolerance for lactose or any other component of the study product(s);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase A: immediate and delayed allergic reactions to DBPCFC with the extensively hydrolyzed whey protein-based infant formula; <br />Phase B: gastro-intestinal tolerability and allergic symptoms.
- Secondary Outcome Measures
Name Time Method Phase A: none; <br />Phase B: product convenience.