Tolerability and Safety of An Infant Formula
Not Applicable
Completed
- Conditions
- Milk Hypersensitivity
- Interventions
- Other: Nutramigen Lipil (Infant formula)
- Registration Number
- NCT00938483
- Lead Sponsor
- Perrigo Nutritionals
- Brief Summary
The purpose of this study is to evaluate an extensively hydrolyzed formula in infants with cow's milk allergy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 108
Inclusion Criteria
- clinically diagnosed CMA
- </= 12 weeks at time of study entry
- full-term infant
- must be willing to use provided formula as sole source of nutrition
- other than CMA, infant must be otherwise healthy
Exclusion Criteria
- underlying or confounding gastrointestinal abnormalities
- infants born from an addictive situation, HIV positive
- if parent/guardian is considered likely to be non-compliant with the protocol requirements
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Extensively hydrolyzed infant formula Nutramigen Lipil (Infant formula) New extensively hydrolyzed formula, NPS-202 Infant formula - Extensively hydrolyzed Nutramigen Lipil Nutramigen Lipil (Infant formula) Currently marketed extensively hydrolyzed formula (Nutramigen Lipil)
- Primary Outcome Measures
Name Time Method Infant reactivity to an extensively hydrolyzed infant formula 29 days
- Secondary Outcome Measures
Name Time Method