Hypoallergenicity of a Hydrolyzed Rice Protein-based Formula in Infants and Young Children With Cow's Milk Protein Allergy

Exclusion Criteria

• •1. Child is exclusively breastfed
• •2. Any chronic medical diseases (except atopic eczema), chromosomal or major congenital anomalies
• •3. Congenital heart disease or treatment by B-blockers
• •4. Major gastrointestinal disease / abnormalities (other than CMPA)
• •5. Known or suspected soy allergy
• •6. Glucose-galactose malabsorption
• •7. Immunodeficiency
• •8. Children who are unable to discontinue antihistamine use (excluding eye drops) within 7 days prior to a food challenge and oral steroid use within 14 days prior to enrollment
• •9. Persistent wheeze or chronic respiratory disease
• •10. Severe uncontrolled eczema or urticaria
• •11. Rice protein allergy or intolerance (e.g., rice protein-induced enterocolitis syndrome), or allergy to any ingredient in the formulas
• •12. Child's parent has other medical or psychiatric condition that, in the judgement of the Investigator, would make the child inappropriate for entry into the study
• •13. Currently participating or having participated in another interventional clinical study within 4 weeks prior to enrollment
• •14. Child's parents have not reached legal age of majority (18 years).