Safety and Tolerance of a Partly Fermented Infant Formula With Prebiotic Oligosaccharides in Healthy Infants

Inclusion Criteria:

1. Healthy, singleton, term infants

2. Aged ≤14 days at randomisation/enrolment

3. Birth weight within normal range for gestational age and sex

4. Head circumference at birth within normal range for age and sex

5. Maternal age ≥18 years at birth;

6. Intervention arms: exclusively formula fed at randomisation (infants of mothers whoautonomously chose not to breastfeed for any reason before their infant is ≤14 days ofage, and who intend to exclusively formula feed until their infant is at least 17weeks of age); OR Breastfed reference arm: exclusively breastfed at enrolment (infantsof mothers who intend to exclusively breastfeed until their infant is at least 17weeks of age);

7. Written informed consent from parent(s) and/or legal guardian(s), who themselves areaged ≥18 years.

Exclusion Criteria:

1. Infants who require to be fed a special diet other than standard cow's milk basedinfant formula;

2. Infants known or suspected to have cow's milk allergy, soy allergy and/or lactoseintolerance;

3. Infants known or suspected to have current or previous illnesses/conditions orinterventions which could interfere with the study or its outcome parameters, as perthe clinical judgement of the Investigator;

4. Infants with known or suspected congenital diseases or malformations which couldinterfere with the study or its outcome parameters (including, but not limited to: GImalformations, congenital immunodeficiency), as per the clinical judgement of theInvestigator;

5. Infants with previous, current or intended participation in any other clinical studyinvolving investigational or marketed products;

6. Incapability of infants' parents/legally acceptable representatives to comply withstudy protocol or Investigator's uncertainty about the willingness or ability of theparent(s)/legally acceptable representative(s) to comply with the protocolrequirements;

7. Infants born from mothers with significant medical conditions during pregnancy thatmight interfere with the study or known to affect intra-uterine growth (e.g. placentaprevia, pre-eclampsia, eclampsia, gestational diabetes requiring insulin or oralmedication) as per Investigator's judgement. Criteria for lactating mothers of subjects in the breastfed reference arm:

8. Lactating women who are currently participating or intend to participate in any otherclinical study involving investigational products. Participation in purelyobservational studies is permitted;

9. Lactating women known to suffer from hepatitis B or human immunodeficiency virus;

10. Lactating women known to have any other significant medical condition(s) which mightinterfere with the study or its outcome parameters (breast abscess or mastitis whichcould interfere with lactation, or other clinically relevant infections, orconsumption of medication/substances which could impact the infants' growth), as perthe clinical judgement of the Investigator;

11. Lactating women who intend to feed their infants with a combination of human milk andinfant formula.