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

United Pharmaceuticals

Status: Completed

Conditions: Milk Hypersensitivity; Protein Allergy; Food Sensitivity

Treatments: Dietary Supplement: extensively hydrolyzed rice protein formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT01998074

UP2010-Paradice

BUN 143201010095 (Other Identifier)

Details and patient eligibility

About

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.

Sex: All

Ages: 2 weeks to 6 months old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 1 patient group

Study formula

Experimental group

Treatment:

Dietary Supplement: extensively hydrolyzed rice protein formula