Hypoallergenicity Evaluation of a New Extensively Hydrolyzed Formula

Hypoallergenicity Evaluation of a New Extensively Hydrolyzed Formula

Infants/children with cow's milk allergy will take part in 2 double-blinded placebo-controlled food challenges (DBPCFC) of 2 extensively hydrolyzed formulas in random order. If both food challenges are passed, subjects will be asked to consume the Test formula in an at-home open challenge for 7 days.

Inclusion Criteria:

• Born at term (>36 weeks gestation)
• 2 months to <4 years of age at enrollment
• Documented CMA within 6 months prior to enrollment
• Otherwise healthy
• Having obtained his/her legal representative's informed consent

Exclusion Criteria:

• Children consuming mother's milk at the time of inclusion and during the trial
• Any chromosomal or major congenital anomalies
• Chronic medical diseases (ie seizure disorders, chronic lung disease, heart problems (heart murmurs okay))
• Immunodeficiency
• Anaphylaxis to any food
• Receiving free amino acid formula
• Subject who in the Investigator's assessment cannot be expected to adhere to the study protocol
• Currently participating in another clinical trial