Addition to Infant Formula of 2-fucosyllactose (2-FL)

METHODOLOGY/ STUDY DESIGN: This study is double blinded-randomized controlled trial with two
arms and a reference breast fed group. The experimental variable is the composition of infant
formula fed to healthy term infants for a period of 16 weeks upon entering the study as their
sole source of nutrition. The formulations are a commercial control (Control, NPS-E23); and
the control formula containing the human milk oligosaccharide (HMO) 2-fucosyllactose (2FL) at
1g/L (HMO, NPS-E23XA).

Infants will be enrolled on or before 14 days of age and fed a study assigned formula for 16
weeks. Weight, length and head circumference will be measured at baseline and 2, 4, 6, 8, 12
and 16 weeks of study entry. Formula volume will be recorded for a three-day period before
each visit. Fecal samples will be obtained at baseline (convenience samples) and at week 16
for all subjects and analyzed for microbial populations. Buccal cheek cells of all infants,
and mothers of breast fed infants, obtained by swab at week 16 will be genotyped for FUT2.
Information on adverse events and new/change of medications will be collected at in person
visits and by telephone interviews between in-person visits.

NUMBER OF SUBJECTS: It is estimated that approximately up to approximately 200 subjects will
be enrolled in the formula groups to obtain up to approximately 65 evaluable per protocol
subjects in each group. As non-randomized reference group of approximately 85 breastfed
infants will be enrolled to obtain approximately 65 evaluable infants.

Inclusion Criteria:

- 1. At birth:

- Healthy, term (37-42 weeks), appropriate for gestational age 2. At the time of
enrollment:

- < 14 days post-natal age at time of enrollment, either gender

- Exclusively formula fed or breastfed upon enrollment Subject must be in general
good health and free from any clinically significant disease, condition, or
illness that might interfere with the study evaluations. Prior labs must be
present to confirm good health.

- Formula group infants: Mother has determined to use infant formula exclusively
for feeding her baby through at least 16 weeks.

- Reference breastfed infants: Mother has determined to breastfeed exclusively
through at least 16 weeks Written informed consent of parent/guardian, prior to
any study related procedures being performed.

Exclusion Criteria:

- 1. Any clinically significant abnormal findings, as determined by the investigator, on
the subject's medical history or physical exam during screening.

2. Use of systemic medications by the subject that in the Investigator's opinion could
impact evaluation of the subject's assessments.

3. Discontinuation of exclusive breastfeeding by reference group (breastfed) infants.

4. Fed with baby/solid foods on average more than once per day.