Clinical Safety of a New Infant Starter Formula Containing 2 Human Milk Oligosaccharides (HMOs)

Clinical Safety of a New Infant Starter Formula Containing 2 Human Milk Oligosaccharides (HMOs)

The primary objective of this clinical study is to show that infants fed a standard starter infant formula with 2 Human Milk Oligosaccharides (HMOs) have a growth in line with infants fed a standard starter infant formula without HMOs.

Inclusion Criteria:

• Healthy babies
• Full term babies (37 weeks ≤ gestation ≤ 42 weeks)
• birth weight between 2500 g- 4500g
• Having obtained the baby's legal representative's informed consent.
• FF groups:

babies aged between birth and 14 days, exclusively formula-fed at time of enrollment, whose mother independently elected, before enrollment, not to breastfeed

• BF group: babies aged 3 months (+/- 5 days), exclusively breastfed since birth.

Exclusion Criteria:

• Congenital illness or malformation that may affect growth
• Significant pre-natal and/or serious post-natal disease before enrollment (by medical decision)
• Minor parent(s)
• Newborn whose parents / caregivers cannot be expected to comply with study procedures
• Currently participating or having participated in another clinical trial since birth, except for BF group, where vaccines studies are allowed.