Safety and Efficacy of Infant Formulas Supplemented With Pre- and Probiotic(s)

Inclusion Criteria:

1. Evidence of personally signed and dated informed consent document indicating thatthe infant's parent(s)/ legally accepted representatives LAR have been informed ofall pertinent aspects of the study.

2. Infants whose parent(s)/LAR have reached the legal age of majority in the countrieswhere the study is conducted.

3. Infants whose parent(s)/LAR are willing and able to comply with scheduled visits,and the requirements of the study protocol.

4. Infants whose parent(s)/LAR are able to be contacted directly by telephonethroughout the study.

5. Infants must meet all of the following inclusion criteria to be eligible forenrollment into the study:

6. Healthy term infant (≥37 weeks of gestation)

7. At enrollment visit, post-natal age ≤14 days/0.5 months

8. Birth weight ≥ 2500g and ≤ 4500g.

9. For formula-fed groups, infants must be exclusively consuming and tolerating acow's milk infant formula at time of enrollment and their parent(s)/LAR musthave independently elected, before enrollment, not to breastfeed.

10. For the breastfed group, infants must have been exclusively consuming breastmilk since birth, and their parent(s)/LAR must have made the decision tocontinue exclusively breastfeeding until at least 4 months of age.

Exclusion Criteria:

1. Infants with conditions requiring infant feedings other than those specified in theprotocol.

2. Infants who have a medical condition or history that could increase the riskassociated with study participation or interfere with the interpretation of studyresults, including:

3. Evidence of major congenital malformations (e.g., cleft palate, extremitymalformation)

4. Suspected or documented systemic or congenital infections (e.g., humanimmunodeficiency virus, cytomegalovirus, syphilis)

5. Previous or ongoing severe medical or laboratory abnormality (acute or chronic)which, in the judgment of the investigator, would make the infant inappropriatefor entry into the study. Of note, children who are normally healthy but at thetime of enrollment suffering from acute illness in a minor condition which arecommon in childhood and do not require some of the exclusionary medicationmentioned below can be enrolled.

6. Infants who are presently receiving or have received prior to enrollment any of thefollowing: medication(s) or supplement(s) which are known or suspected to affect thefollowing: fat digestion, absorption, and/or metabolism (e.g., pancreatic enzymes);stool microbiota and characteristics (e.g., oral or systemic antibiotics, glycerinsuppositories, bismuth-containing medications, docusate, Maltsupex, or lactulose);growth (e.g. insulin or growth hormone); gastric acid secretion.

7. Currently participating or having participated in another clinical trial sincebirth.

8. Subjects or subjects' parent(s) or legal representative who are not willing and notable to comply with scheduled visits and the requirements of the study protocol