Infant Microbiota and Probiotic Intake Study



Status:Active, not recruiting
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:21 - 45
Updated:9/8/2018
Start Date:November 2014
End Date:June 2027

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Infant Supplementation With Probiotic Bifidobacterium Longum Subsp. Infantis Study

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.

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.

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
We found this trial at
1
site
2315 Stockton Blvd.
Sacramento, California 95817
(916) 734-2011
Principal Investigator: Jennifer Smilowitz, PhD
Phone: 530-752-1057
University of California, Davis Medical Center UC Davis Medical Center serves a 65,000-square-mile area that...
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mi
from
Sacramento, CA
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