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

N/ACompletedNCT01998074

United Pharmaceuticals

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Conditions

Milk Hypersensitivity Food Sensitivity Protein Allergy

Interventions

extensively hydrolyzed rice protein formulaDIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 2 WeeksMax age: 6 Months

Medical Language ↔ Plain English

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

Locations (1)

Universitair Ziekenhuis

Brussels, Belgium

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

Time frame: at 3 months

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

Time frame: at 6 months

Growth (weight, height, head circumference)

Time frame: 1 month

Growth (weight, height, head circumference)

Time frame: 3 months

Growth (weight, height, head circumference)

Time frame: 6 months

Data from ClinicalTrials.gov

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