This study is in progress, not accepting new patients

Infant Microbiota and Probiotic Intake Study

Summary

Eligibility
for females ages 21-45 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at Sacramento, California
Dates
study started
study ends around
Principal Investigator
by Jennifer Smilowitz, PhDMark Underwood, MD

Description

Summary

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.

Official Title

Infant Supplementation With Probiotic Bifidobacterium Longum Subsp. Infantis Study

Details

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.

Keywords

Healthy, C-section, Infants, Probiotic, B. infantis, Microbiota, Gut, Breast milk, Vaginal, Bifidobacterium

Eligibility

You can join if…

Open to females ages 21-45

  • 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

You CAN'T join if...

  • 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

Location

  • University of California, Davis Medical Center
    Sacramento California 95817 United States

Lead Scientists at UC Davis

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Davis
ID
NCT02457338
Study Type
Interventional
Participants
Expecting 120 study participants
Last Updated