Gut Health,Feces Characteristics and Growth of Infants Fed With a New Infant Organic Formula

The goal of this clinical trial is to evauate the gut health, feces characteristics and growth of infants fed with a new study organic formula (investigational formula).75 eligible infants of 30 days old will be enrolled at one center and randomized to feed the investigational formula, control formula, and breast milk for 3 months.Researchers will compare the three groups to evaluate the gut health, feces characteristics and growth of infants by the end of the study.

Inclusion Criteria:30 days of age at randomization and enrollment, inclusive (day of birth is considered day 0)Plan to exclusively formula feed (formula groups) OR exclusively feed human milk (breastfeeding group)Singleton birthGestational age of 37-42 completed weeks (37 weeks 0 days through 42 weeks 6 days)Birth weight of 2490g to 4200gSigned informed consent obtained for infant's and mother's participation in the studyExclusion Criteria:History of underlying metabolic or chronic disease; congenital malformation; or any other condition which, in the opinion of the Investigator, is likely to interfere with: the ability of the infant to ingest food, the normal growth and development of the infant, or the evaluation of the infantEvidence of feeding difficulties or formula intolerance, such as vomiting or poor intake, at time of randomization (at investigator discretion)Infants with a known allergy to cow's milk protein or a well-documented family history of allergy to cow's milk proteinWeight at randomization is <90% of birth weight [(weight at Visit 1÷birth weight) x 100 <90%]Infant is immunocompromised (according to a doctor's diagnosis of immunodeficiency such as Combined Immunodeficiencies, DiGeorge Syndrome, Wiskott-Aldrich Syndrome, Severe Congenital Neutropenia and Secondary Immunodeficiencies linked to HIV infection, Down Syndrome or others)Known head/brain disease/injury such as microcephaly, macrocephaly or others.Enrollment in another interventional clinical research study while participating in this study