Food Sensitivity, Milk Hypersensitivity, Protein Allergy
Conditions
Keywords
Cow's Milk protein Allergy
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.
Interventions
DIETARY_SUPPLEMENTextensively hydrolyzed rice protein formula
Sponsors
United Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
2 Weeks to 6 Months
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical improvement of symptoms of cow's milk protein allergy, through the use of a validated score | at 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Belgium
Outcome results
None listed