About this trial
The main purpose of this study is to assess the efficacy of a partially hydrolyzed formula with synbiotics in halting one of the first steps of the allergic march (atopic dermatitis) in infants at risk of allergy. Other efficacy and safety parameters will be assessed as well.
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
Infant postnatal age ≤ 14 days (date of birth = day 0) at enrollment
Disqualifiers
Infectious, metabolic, congenital, genetic, gastrointestinal illness or any other condition (e.g., gastrointestinal surgery) that could impact oral feeding, growth or study outcomes.
Infants with special dietary needs other than standard infant formula (e.g., extensively hydrolyzed formula, amino acid formula, special formula for metabolic diseases) or requiring tube feeding.
Infant has already been diagnosed with allergy by a physician, including AD and/or cow's milk allergy.
Infant is currently participating or has previously participated in another clinical trial prior to enrollment.
Trial design
Treatments tested in this trial
- Test formula
- Control formula