Expired Study
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Sacramento, California 95817


Purpose:

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.


Study summary:

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.


Criteria:

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 UCDMC or a 20-mile radius from UC Davis Campus in Davis, CA - 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


NCT ID:

NCT02457338


Primary Contact:

Principal Investigator
Jennifer Smilowitz, PhD
University of California, Davis


Backup Contact:

N/A


Location Contact:

Sacramento, California 95817
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 19, 2017

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