About this trial
The main purpose of this study is to demonstrate that the growth of infants fed with the Test Formula is non-inferior those fed with the Control Formula. The study will also evaluate the gastrointestinal tolerance, quatliy of life and acceptability of the new rice protein-based formula in infants with cow's milk protein allergy (CMPA).
Eligibility criteria
Qualifiers
Written informed consent has been obtained from at least one parent (or legally acceptable representative [LAR]), if applicable)
Infant gestational age ≥ 37 completed weeks
Infant birth weight of ≥ 2.5 kg and ≤ 4.5 kg
Singleton birth
Disqualifiers
History of intolerance to eHF formula
Any chronic medical diseases (except atopic eczema), chromosomal or major congenital anomalies (based on medical history and/or commonly performed diagnostic criteria)
Major gastrointestinal disease / abnormalities (other than CMPA)
Known or suspected lactose intolerance or malabsorption
Trial design
Treatments tested in this trial
- Test Formula
- Control Formula