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Clinical Trials/NCT02351531
NCT02351531
Completed
Phase 3

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

United Pharmaceuticals3 sites in 3 countries32 target enrollmentNovember 2013
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ConditionsCow Milk Allergy

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Cow Milk Allergy
Sponsor
United Pharmaceuticals
Enrollment
32
Locations
3
Primary Endpoint
Number of patients dropped out for intolerance
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
November 2013
End Date
December 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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,

Outcomes

Primary Outcomes

Number of patients dropped out for intolerance

Time Frame: 2 weeks

Secondary Outcomes

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

Study Sites (3)

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