Rescuing the Microbiome Effectively With Different Doses of B. Infantis in Infants

Mother-infant dyads will be enrolled when the infant is 2-4 months of age. A 1-week lead-in
period will be utilized to collect baseline microbiome samples and for the completion of
daily and weekly feeding and health logs. Subjects that meet eligibility criteria on Day 7
will be randomized into 1 of 4 treatment arms. Supplementation will begin on Day 8 and will
continue for a total of 28 consecutive days. Subjects will be followed for an additional 4
weeks after the cessation of the supplement. The total duration of the study will be
approximately 9 weeks. Infant stool and urine samples, as well as maternal breast milk
samples, will be collected on multiple occasions during the study. Mothers will be asked to
complete questionnaires and health logs during the course of the study as well.

Inclusion Criteria:

- Age of subjects: Infants: 60 to 122 days old, Mothers: 21 years old and greater

- Mother-infant dyads who live within a 40-mile radius from the clinical site

- Infants predominately breastfed with maternal intent to continue exclusive
breastfeeding for at least 9 additional weeks

- Term infants born >37 weeks gestation

- Healthy infants without medical complications

- Generally healthy women

- Mothers who are willing to refrain from feeding their infants infant formula, solid
foods, and probiotic or iron supplements (confounding variables of the intestinal
microbiome) before the end of the study

Exclusion Criteria:

- Mothers diagnosed with any metabolic, endocrine, liver, or kidney disease, any
autoimmune disease, cirrhosis, hepatitis C, HIV, AIDs, cancer, obesity (pre-pregnancy
BMI >34.9 kg/m2), Crohn's disease, heart disease, type 1 or type 2 diabetes

- Infants born in a multiple birth

- Infants born with medical complications such as: respiratory distress syndrome or
birth defects

- Infants with any GI tract abnormalities

- Infants who have taken antibiotics within 4 weeks of enrollment or during the Lead-in
Period

- Infants who have taken iron supplements within 4 weeks of enrollment or during the
Lead-in Period

- Infants who have consumed any infant formula within 4 weeks of enrollment or more than
10 times between birth and enrollment or during the Lead-in Period

- Infants whose parents plan to feed them any infant formula any time throughout the
duration of the study

- Infants who have consumed any probiotics containing B. infantis since birth

- Infants who have consumed any Bifidobacterium-containing probiotics within 4 weeks of
enrollment or during the Lead-in Period

- Infants whose parents plan to administer probiotics to them any time throughout the
duration of the study (not including the study supplement)

- Infants who have consumed any solid foods or beverages between birth and enrollment or
during the Lead-in Period (liquid medicines, supplements, and sugar water are ok)

- Infants whose parents plan to feed them solid foods or beverages any time throughout
the duration of the study

- Infants whose mothers have changed their minds about their plans to exclusively
breastfeed for at least 8 additional weeks by Day 7

- For infants born vaginally, maternal intake of probiotics containing B. infantis
during the last trimester of pregnancy

- Mother-infant dyads who live in more than one location

- Infants who have been diagnosed with any medical or nutritional condition that would
require iron supplementation

- Mothers who smoked cigarettes during pregnancy, currently smoke, or plan to initiate
smoking during the study duration

- Anyone the investigator feels isn't an applicable subject