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.
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
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.
Parallel
Test formula
Other interventionPartially hydrolyzed formula with synbiotics
Control formula
Other interventionIntact protein formula without synbiotics
TransEpidermal Water Loss (TEWL) at 3 months
TransEpidermal water loss will be measured using a validated non-invasive technique.
Cumulative incidence of Atopic Dermatitis
Cumulative incidence of AD is based on physician diagnosis using the United Kingdom Working Party (UKWP) diagnosis criteria.
TransEpidermal Water Loss
Epidermal water loss will be measured using a validated non-invasive technique.
Skin surface (stratum corneum) hydration
Skin hydration will be measured with a corneometer device.
Extent and severity of Atopic Dermatitis
SCORAD (SCORing for Atopic Dermatitis), scores range from 0 to 103, with higher scores indicating higher atopic dermatitis severity
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