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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
176
Kinderartsenpraktijk
Hasselt, Belgium
Dipartimento Materno Infantile
Palermo, Italy
Growth
child growth (body weight) from enrollment to 4 months of age
Time frame: 4 months of life
Growth
Time frame: 6 and 12 months of age
Digestive tolerance (stool charecteristics, bowel movements,behavior patterns)
Parents are asked to complete a diary on digistive tolerance of their child
Time frame: every month during 6 months
Product compliance (quantity of formula in ml consumed on the 3 days before visit)
Parents are asked to complete a diary on the product compliance
Time frame: every month for 6 months
Morbidity
Time frame: ongoing for 1 year
Stool microbiota
Time frame: 3 and 12 months of age
Gene expression
Time frame: 3 and 12 months of age
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