Effects of an Infant Formula and follow-on Formula Containing Bio-active Ingredients on Growth, Tolerance and Infections

Inclusion Criteria:

• Full-term infants

• Healthy birthweight: 2500 g ≤ birthweight ≤ 4200 g

• Boys and girls

• Apparently healthy at birth and screening

• Weight-for-age Z-score (WAZ) at screening within the normal range according to WHOChild Growth Standards

• Age at enrolment: ≤60 days of age

• If age at inclusion ≤1 month: infants exclusively formula fed for at least 5 daysprior to inclusion

• If 1 month < age at inclusion ≤ 2 months: infants exclusively formula fed since 1month old2

• Being available for follow up until the age of 12 months

• Written informed consent from parent(s) and/or legal guardian(s) aged ≥18 years

Exclusion Criteria:

• Severe acquired or congenital diseases, mental or physical disorders, includingcow's milk protein allergy (CMA), lactose intolerance and diagnosed medicalconditions that are known to affect study outcomes (e.g. functionalgastro-intestinal disorders (FGID))

• Incapability of parents to comply with the study protocol

• Illiterate parents (i.e. not able to read and write in local language)

• Participation in another clinical trial

• Unwillingness to accept the formula supplied by the study as the only formula fortheir child until the age of 12 months

• Infants fed a special diet other than standard cow's or goat's milk based (non-hydrolyzed) infant formula prior to inclusion