A Double-blind Randomized Controlled Trial of a Thickened Amino-acid-based Formula in Children Allergic to Cow's Milk and to Protein Hydrolysates

Not Applicable

Completed

• Conditions: Cow Milk Allergy
• Interventions: Dietary Supplement: Amino acid based formula

• Registration Number: NCT01940068
• Lead Sponsor: United Pharmaceuticals

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;

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2013-07
• Study First Submitted: 2013-09-06
• Study First Submitted QC: 2013-09-06
• Study First Posted: 2013-09-11
• Study Completion: 2013-12
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-20
• Last Update Posted: 2015-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
New Thickened Amino acid based formula	Amino acid based formula	-
Amino acid based formula	Amino acid based formula	-

Primary Outcome Measures

Name	Time	Method
Number of withdrawal for intolerance	1 month

Trial Locations

Locations (1)

Necker Children's Hospital; 🇫🇷 Paris, France