Milk Oriented Microbiota

The purpose of phase 1 of this two phase clinical trial is to determine: 1) the effect of
decreasing levels of human milk oligosaccharides on fecal B.infantis during and after 21 days
of supplementation with Evolve activated B.infantis using exclusively breastfed, mixed-fed
and exclusively formula-fed infants; 2) determine the effect of Evolve activated B.infantis
on fecal B.infantis levels in exclusively breastfed infants compared to pre-supplementation
levels.

Inclusion Criteria:

- Women with infants age 8 to 12 weeks

- Term infants born >37 weeks gestation

- Mother-infant pairs who live within a 20-mile radius from UC Davis campus in Davis, CA
or within a 20-mile UCDMC

- Women and infants who live in one location

- Infants born vaginally

- Infants who are either exclusively formula-fed, exclusively breastfed or mixed-fed

- Women who are mixed and formula feeding their infants who are willing to switch infant
formulas and use the study's infant formula (Earth's Best Organic Infant Formula With
Iron, Earth's Best) throughout the first two months of the study

- Women who are breastfeeding but introduce infant formula to their infants during the
first two months of the study who are willing to use the study's infant formula
(Earth's Best Organic Infant Formula With Iron, Earth's Best) for the first two months
of the study

Exclusion Criteria:

- Women who have lived in the United States or other developed nation for less than 10
consecutive years

- Multiple infants born to one mother

- Plan to feed infants solid foods before infants turn 5 months of age

- Family history of cow milk or soy allergy and/or infants allergic to cow milk protein
or soy

- Infants born by C-section

- Infants born with medical complications such as: respiratory distress syndrome, birth
defects, and infection

- Infants who have taken antibiotics 4 weeks before enrollment and more than one course
of antibiotics since birth

- Infants who have taken probiotics since birth

- Plan to administer probiotics to infants or use of probiotics other than the study
supplement by infants for the first two months of the study

- Mothers who have a chronic metabolic disease or obesity

- Mothers who currently smoke or plan to resume smoking during the study period

- Infants who consume solid foods or other liquids other than breastmilk, infant formula
or water