Eligibility Details:
Inclusion Criteria:
- Women, age 21 to 45 years who have delivered a healthy single infant by vaginal
delivery and their infants, age 4 to 7.5 months;
- Infants who are developmentally ready for solids;
- Generally healthy women and infants;
- Mothers who plan to exclusively (without solids or infant formula) breastfeed (at the
breast or feed breast milk by bottle) their infants for at least 5 months of age and
plan to continue to breastfeed with solids and/or infant formula until 12 months of
age;
- Mothers who are willing to either use their own breast pump, or hand-express, or use a
manual pump provided by the study to collect milk samples;
- Mothers who are willing to refrain from feeding their infants infant formula,
non-study solid foods; probiotic or iron supplements (confounding variables of the
intestinal microbiome) before the end of the feeding intervention period;
- Term infants born >37 weeks gestation;
- Mother-infant pairs who live within a 20-mile radius from UC Davis campus in Davis, CA
(includes Woodland, Vacaville, Dixon and surrounding areas) or within a 20-mile UCDMC
(2221 Stockton Blvd, Sacramento, CA 95817).
Exclusion Criteria:
- Infants with any GI tract abnormalities;
- Infants born by cesarean section;
- Family history of immunodeficiency syndrome(s);
- Multiple infants born to one mother at the same time (no twins, triplets, etc.);
- Infants born with medical complications such as: respiratory distress syndrome, birth
defects, and infection;
- Mothers diagnosed with any metabolic or endocrine, liver, kidney disease, any
autoimmune disease, cirrhosis, hepatitis C, HIV, AIDs, cancer, obesity (pre-pregnancy
BMI >34.9), PCOS, celiac disease, Crohn's disease, heart disease, hyper- or
hypothyroidism, hyper- or hypotension (including pre-eclampsia), type 1 or type 2
diabetes.
- Mothers who smoked cigarettes less than one month before becoming pregnant, during
pregnancy, and currently or mothers who plan to initiate smoking during the study
duration;
- Infants who have taken antibiotics within the past 4 weeks;
- Infants who have taken iron supplements within the past 4 weeks;
- Infants who have consumed infant formula in the past 4 weeks;
- Infants who have consumed infant formula more than 10 days between birth and 4 weeks
prior to screening;
- Infants who have consumed any solids;
- Mothers who plan to feed infants solids before 5 months of age;
- Mothers who plan to administer any probiotics to infants throughout the feeding
intervention period (first 18 days of the study);
- Infants who have consumed probiotics containing Bifidobacterium within the past 4
weeks or other probiotics within the past 7 days;
- Mothers who live in more than one location (should only live in one house to ensure
samples are correctly collected and stored);
- Infants who have hypotonia,
- Infants who have been diagnosed with any medical or nutritional condition that would
require iron supplementation.
- Infants who on average pass less than one stool per week.
common.study.methods.has-drugs-no
common.study.methods.is-healthy-no
