Effect of Partially Hydrolyzed Formula With Synbiotics on Skin Barrier Function

Prior treatment

• Infant is currently participating or has previously participated in another clinical trial prior to enrollment.

Other illness

• 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.

Age

• Infant's parents or LARs have not reached legal age of majority (18 years).

• 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
• Infant from singleton birth or infant from multiple births may if all birth siblings are enrolled.
• At least one biological parent or sibling has (or had) a medically diagnosed history of allergy, based on response to a simple screening questionnaire
• a. For the breastfed reference group only: infant is exclusively breastfed since birth with no intake of formula, and their parent(s) have the intention to continue exclusive breastfeeding until at least 4 months of age.
  • or b. For the randomized formula-fed groups only: infant is exclusively or predominantly formula-fed in the 24 hours prior to enrollment, with formula feeding representing at least 75% of total daily feeds. The decision to introduce formula feeding was independently made by the parents before enrollment.
• Parents/LAR must be able to provide evidence of parental authority and identity.
• Infant's parent(s)/LAR must understand the informed consent form and other study documents and are willing and able to fulfill the requirements of the study protocol.