Cow Milk Allergy: Evaluation of the Efficacy of a New Thickened Extensively Hydrolyzed Formula in Infants With Confirmed Cow Milk Allergy

Phase 3

Completed

• Conditions: Cow Milk Allergy
• Interventions: Dietary Supplement: Extensively Hydrolyzed formula

• Registration Number: NCT02351531
• Lead Sponsor: United Pharmaceuticals

Brief Summary

The aim of the study is to assess the hypoallergenicity of a new thickened extensively hydrolyzed formula.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Primary Completion: 2014-12
• Status Verified: 2015-01
• Study First Submitted: 2015-01-21
• Study First Submitted QC: 2015-01-27
• Last Update Submitted: 2015-01-27
• Study First Posted: 2015-01-30
• Last Update Posted: 2015-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• between 1 and 12 months old
• having a cow milk allergy confirmed by a positive double-blind food challenge performed in the last 3 months,
• whose parent(s) signed the informed consent form

Exclusion Criteria

• Infants mainly or exclusively breastfed,
• Infants having a weight at inclusion < 2500g,
• Infants who refused to drink an extensively hydrolyzed formula anytime prior to inclusion,
• Infants fed an amino acid based formula
• Infants who had an anaphylactic reaction in the past,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
New Thickened Extensively Hydrolyzed formula	Extensively Hydrolyzed formula	-

Primary Outcome Measures

Name	Time	Method
Number of patients dropped out for intolerance	2 weeks

Secondary Outcome Measures

Name	Time	Method
Cow's milk protein hypersensitivity score	2 weeks
Growth (weight, height, head circumference)	4 months

Trial Locations

Locations (3)

Necker Children's Hospital; 🇫🇷 Paris, France

University of Naples Federico II; 🇮🇹 Naples, Italy

Centre Hospitalier Régional; 🇧🇪 Namur, Belgium