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
Primary Investigator(s)
Todd Green, MD
Contact Information
To get started, please contact:
Judy Fulton, RD, LDN
1-877-296-9026
