Research

Formula for Infants with Cow Milk Allergy

Nutritional Safety and Hypoallergenicity of an Amino Acid-Based Formula in Infants Diagnosed with Cow Milk Allergy

Protocol Description

In this multi-center study, researchers will evaluate a new Neocate formula for effectiveness at promoting growth when used in subjects allergic to cow milk. Existing Neocate Infant formula is hypoallergenic and used by children with cow milk allergy, other food allergies and other gastrointestinal disorders. The new Neocate formula blends ingredients that more closely resemble breast milk, aiding in a child’s growth.

Eligibility Criteria

This study is accepting infants of both sexes, 8 months of age and younger, who have been recently diagnosed with a cow milk allergy.
Boys: Up to 8 months old
Girls: Up to 8 months old

Requirements
In addition to the screening visit and initial testing, participants will be randomly assigned to receive either Neocate Infant formula or the new Neocate formula. Parents will maintain a food diary for recording the child’s dietary patterns.
Visits: 7
Duration: Approximately 4 months

Status: Open for Enrollment

Source of Support
Nutricia North America

Additional Resources
Study description at National Institutes of Health