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Clinical Trials/NCT01998074
NCT01998074CompletedNot Applicable

Evaluation of the Efficacy of a New Extensively Hydrolyzed Formula in Infants With Cow's Milk Protein Allergy

United Pharmaceuticals1 site in 1 countryStarted: November 28, 2013Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Locations
1
Primary Endpoint
Clinical improvement of symptoms of cow's milk protein allergy, through the use of a validated score
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The aim of the study is to show the efficacy, tolerance and nutritional adequacy of a newly developed hydrolyzed rice formula in infants with a proven cow's milk protein allergy.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment

Eligibility Criteria

Ages
2 Weeks to 6 Months (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Infants between 2 weeks and 6 months old
  • •In whom cow's Milk Protein Allergy has been proved by a food challenge performed during the previous month

Exclusion Criteria

  • •Exclusively breast fed infants
  • •Preterm infants
  • •Infants already fed with an extensively hydrolyzed formula with no improvement of the symptoms.
  • •Infants fed an amino acid based formula
  • •Infants who had an anaphylactic reaction in the past

Arms & Interventions

Study formula

Experimental

Intervention: extensively hydrolyzed rice protein formula (Dietary Supplement)

Outcomes

Primary Outcomes

Clinical improvement of symptoms of cow's milk protein allergy, through the use of a validated score

Time Frame: at 4 weeks

Secondary Outcomes

  • Clinical improvement of symptoms of cow's milk protein allergy, through the use of a validated score(at 6 months)
  • Growth (weight, height, head circumference)(6 months)
  • Clinical improvement of symptoms of cow's milk protein allergy, through the use of a validated score(at 3 months)
  • Growth (weight, height, head circumference)(1 month)
  • Growth (weight, height, head circumference)(3 months)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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