Study Evaluating Growth and Tolerance of Infant Formula Containing HMOs
Study Evaluating Growth and Tolerance of Infant Formula Containing HMOs
The primary objective of this clinical study is to investigate the suitability of an infant
 formula containing five different human milk oligosaccharides to support normal physical
 growth (evaluated per weight gain), in comparison with infant formula without human milk
 oligosaccharides, when the formula is fed as the sole source of nutrition.
The main goal of the study is to investigate the suitability of an infant formula containing
 five different human milk oligosaccharides to support normal physical growth of term infants
 (evaluated per weight gain, body length and head circumference), in comparison with infant
 formula without human milk oligosaccharides, when the formula is fed exclusivly in the first
 four month of life. Additionally, a comparison of the two formula fed groups against a
 reference group with breastfed infants as well as the WHO growth standard reference tables
 will be performed. An assessment of safety and tolerability will be performed as well.

 As a secondary out come of the study, we will examine the effect of the formula on the infant
 microbiome, as well as the HMO status of the mother's milk towards the microbial composition
 of the infant microbiome.
Inclusion Criteria:

 -  Singleton birth

 -  Full-term infant (37 - 42 weeks of gestational age)

 -  APGAR score of 9 or 10

 -  Birth weight 2500 - 4500 g

 Exclusion Criteria:

 -  clinically significant condition/ disorder

 -  Adverse maternal of fetal medical history that may influence growth/development of the
 subject or tolerance of the infant formula

 -  readmission to hospital (except for hyperbilirubinemia)

 -  allergy to cow's milk

 -  participation in another study