Trial | NCT02457338  Report issue

Title

Infant Microbiota and Probiotic Intake Study
Infant Supplementation With Probiotic Bifidobacterium Longum Subsp. Infantis Study

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Active, not recruiting

  • Study Participants

    120
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.
Study Started
Nov 01
2014
Primary Completion
Jul 15
2016
Study Completion
Jun 07
2027
Anticipated
Last Update
Nov 28
2023

Dietary Supplement Bifidobacterium

  • Other names: B. infantis

Supplement Group Experimental

This group will receive probiotic B. infantis supplementation, plus standard care and lactation consultation.

Control Group No Intervention

This group will receive standard care plus lactation consultation only.

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 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
No Results Posted