Improved Immunology Outcomes Associated With Lactoferrin Fortified With HMO in Infant Formula

Inclusion Criteria:

• Newborn baby, study entry before weaning (within 28 days of birth)

• Exclusively formula fed for at least 3 days prior to study entry and plan to beexclusively formula fed during the study (formula groups) OR plan to be exclusivelyfed with human milk during the study (breastfeeding group).

• Gestational age of 37-42 weeks (36 weeks and six days is considered 36 weeksgestational age).

• Birth weight of 2500g (5 lbs. 8 oz.) to 4200g (9 lbs. 4 oz.).

• Signed informed consent obtained for infant's participation in the study.

• Parent or guardian of the infant agrees to not enroll the infant in anotherinterventional clinical research study while participating in this study.

Exclusion Criteria:

• History of underlying metabolic or chronic disease; congenital malformation; or anyother condition which, in the opinion of the Investigator, is likely to interferewith: the ability of the infant to ingest food, the normal growth and development ofthe infant, or the evaluation of the infant.

• Evidence of feeding difficulties or formula intolerance, such as vomiting or poorintake, at time of randomization (at investigator discretion).

• Evidence of growth problems or concern for growth.

• Infant was born large for gestational age (LGA) (defined as birth weight-for-ageexceeding 90th percentile as plotted on the growth chart provided by Feihe) frommother who was diabetic at childbirth.

• Participant is immunocompromised (according to a doctor's diagnosis ofimmunodeficiency such as Combined Immunodeficiencies, DiGeorge Syndrome,Wiskott-Aldrich Syndrome, Severe Congenital Neutropenia and SecondaryImmunodeficiencies linked to HIV infection, Down Syndrome or others) and childrenwith known head/brain disease/injury.

• Use of probiotics/prebiotics before the study.