NCT01940068
Completed
Not Applicable
A Double-blind Randomized Controlled Trial of a Thickened Amino-acid-based Formula in Children Allergic to Cow's Milk and to Protein Hydrolysates
ConditionsCow Milk Allergy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cow Milk Allergy
- Sponsor
- United Pharmaceuticals
- Enrollment
- 86
- Locations
- 1
- Primary Endpoint
- Number of withdrawal for intolerance
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the impact of a new Amino-acid based formula on allergic symptoms and growth of infants with cow's milk protein allergy and intolerant to extensively hydrolysed formulas;
Investigators
Eligibility Criteria
Inclusion Criteria
- •less than 18 months old
- •with a proven cow's milk protein allergy by a double blind placebo controlled food challenge or a positive Skin prick test (\>=6mm) or specific immunoglobulin E \>= 5 kilo-unit/L or combination
- •still symptomatic while fed an extensively hydrolysed formula
Exclusion Criteria
- •Exclusively breast fed infants
- •non allergic digestive enteropathy
Outcomes
Primary Outcomes
Number of withdrawal for intolerance
Time Frame: 1 month
Study Sites (1)
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