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

Not Applicable

Completed

• Conditions: Milk Hypersensitivity; Protein Allergy; Food Sensitivity
• Interventions: Dietary Supplement: extensively hydrolyzed rice protein formula

• Registration Number: NCT01998074
• Lead Sponsor: United Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-11
• Primary Completion: 2013-11
• Study First Submitted: 2013-11-22
• Study First Submitted QC: 2013-11-27
• Last Update Submitted: 2013-11-27
• Study First Posted: 2013-11-28
• Last Update Posted: 2013-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study formula	extensively hydrolyzed rice protein formula	-

Primary Outcome Measures

Name	Time	Method
Clinical improvement of symptoms of cow's milk protein allergy, through the use of a validated score	at 4 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Universitair Ziekenhuis; 🇧🇪 Brussel, Belgium