Infant Microbiota and Probiotic Intake Study (IMPRINT)

University of California (UC) Davis

Status

Active, not recruiting

Conditions

Healthy

Treatments

Dietary Supplement: Bifidobacterium

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02457338

631099

Details and patient eligibility

About

The purpose of this study is to determine if supplementing healthy term infants delivered by C-section or vaginal delivery who only consume breastmilk with a probiotic for 21 consecutive days increases levels of bacteria in infants' stool.

Full description

The purpose of this clinical trial is to determine the effects of supplementing the probiotic Bifidobacterium longum subsp. infantis for the first 21 days of life in healthy term breastfed infants delivered via C-section or vaginal delivery on gut bacteria composition during, 1 week, and 1 month after supplementation compared with matched-control term infants receiving standard care. The investigators' specific aim is to compare the fecal microbiota (total B. infantis, total Bifidobacterium, total bacteria and composition of microbiota) between the supplement and control groups.

Enrollment

120 estimated patients

Sex

Female

Ages

21 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy, non-smoking women and their infants
Who are pregnant in their third trimester OR have delivered by C-section or vaginal birth within the past 7 days
Patients who live within a 20-mile radius from University of California Davis Medical Center (UCDMC) or a 20-mile radius from UC Davis Campus in Davis, California.
Plan to exclusively breastfeed their infants for at least 3 months
Infants: 0-7 days old, delivered by C-section or vaginal delivery, born >37 weeks gestation, without medical complications that would preclude breastfeeding or alter gut microbiota

Exclusion criteria

Infants born with medical complications such as: respiratory distress syndrome, birth defects, and infection
Infants who have taken antibiotics for more than 72 hours of life
Infants who have consume formula feedings after day 7 of life
Mothers and their infants who are not discharged from the hospital by day 4 of life due to complications
Plan to administer probiotics to infants or use of probiotics other than the study supplement by infants anytime throughout the study duration
Women who have had any breast surgery or injury within the past 5 years that would reduce the chance of successful exclusive breastfeeding
Mothers who have a chronic metabolic disease or obesity