CMPA-GO Study: Growth and Safety Outcomes in Infants With CMPA Fed a Novel Extensively Hydrolyzed Formula

A Growth, Tolerability, and Safety Study of a Novel Extensively Hydrolyzed Formula (eHF) in Infants With Cow's Milk Protein Allergy (CMPA)

CMPA-GO Study: Growth and safety Outcomes in infants with CMPA fed a novel extensively hydrolyzed formula

Inclusion Criteria:

1. Full term infant (gestational age ≥37 weeks and ≤42 weeks).
2. Birth weight ≥2500 g and ≤4500 g.
3. Infant aged ≥29 days (>4 weeks) and <5 months (≤22 weeks).
4. Not breastfed at time of Screening Visit.
5. History of an immediate-type (IgE-mediated) allergic reaction to a cow's milk-containing food or at least 2 persistent severe symptoms suggestive of delayed-onset (non-IgE-mediated) CMPA.

Exclusion Criteria:

1. Prior use of eHF, HRF or AAF for more than 2 weeks before randomization.
2. Demonstrated chronic malabsorption not due to CMPA.
3. History of anaphylaxis to CMP.
4. Participants with a history of confirmed Food Protein-induced Enterocolitis Syndrome (FPIES) or Heiner syndrome.
5. Any contraindication to the open OFC (eg. unstable respiratory disease), or any disorder in which epinephrine is contraindicated.
6. History of any immunotherapy for CMPA.
7. Past or current disease or disorder which, in the opinion of the Investigator or the sponsor either places the participant at risk because of participating in the study or may influence the results of the study, or the subject's ability to participate in the study.