A Double-blind Randomized Controlled Trial of a Thickened Amino-acid-based Formula in Children Allergic to Cow's Milk and to Protein Hydrolysates
Information source: United Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cow Milk Allergy
Intervention: Amino acid based formula (Dietary Supplement)
Phase: N/A
Status: Completed
Sponsored by: United Pharmaceuticals
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;
Clinical Details
Official title: A Double-blind Randomized Controlled Trial of a Thickened Amino-acid-based Formula in Children Allergic to Cow's Milk and to Protein Hydrolysates
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Number of withdrawal for intolerance
Eligibility
Minimum age: N/A.
Maximum age: 18 Months.
Gender(s): Both.
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
Locations and Contacts
Necker Children's Hospital, Paris, France
Additional Information
Starting date: March 2011
Last updated: March 20, 2015
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