Infant Supplementation With Probiotic Bifidobacterium Longum Subsp. Infantis Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Healthy
- Sponsor
- University of California, Davis
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Incidence of Adverse Events and Treatments
- Status
- Active, not recruiting
- Last Updated
- 4 months ago
Overview
Brief 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.
Detailed 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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
Incidence of Adverse Events and Treatments
Time Frame: Months 4, 6, 8, 10, 12, 18 and 24
Gastrointestinal symptoms and related symptoms (diarrhea, vomiting, constipation, colic, irritability) after B. infantis supplementation will be determined and reported parental self-report questionnaire. General health status of the infant such as occurrence of any illness, health care visits for sickness, fever, antibiotic and medication use and parental assessments of infant's overall health.
Infant fecal B. infantis
Time Frame: baseline, days 10, 14, 17, 21, 25, 29, 32, 40, 50, 60
Measure the change from baseline, during supplementation, and post supplementation
Infant fecal microbiota
Time Frame: baseline, days 10, 14, 17, 21, 25, 29, 32, 40, 50, 60
Measure the change from baseline, during supplementation, and post supplementation
Infant fecal Bifidobacterium
Time Frame: baseline, days 10, 14, 17, 21, 25, 29, 32, 40, 50, 60
Measure the change from baseline, during supplementation, and post supplementation
Infant fecal total bacteria
Time Frame: baseline, days 10, 14, 17, 21, 25, 29, 32, 40, 50, 60
Measure the change from baseline, during supplementation, and post supplementation
Secondary Outcomes
- Fecal B. infantis-Follow-up(Months 4, 6, 8, 10, 12)
- Fecal Bifidobacterium-Follow-up(Months 4, 6, 8, 10, 12)
- Fecal short-chain fatty acids(Baseline-days 60)
- Infant weight(birth, hospital discharge, days 15, 33, 61)
- Fecal inflammatory mediators(Baseline-days 60)
- Infant fecal bacteria oligosaccharide consumption(days 7, 14, 21, 32, 60)
- Fecal gut barrier function barrier markers(Baseline-days 60)
- Infant fecal sialic acid concentrations(baseline, days 10, 14, 17, 21, 25, 29, 32, 40, 50, 60)
- Maternal fecal B. infantis, Bifidobacterium, total bacteria, and microbiota composition(baseline, day 60)
- Fecal lipopolysaccharide(Baseline-days 60)
- Fecal microbiome-Follow-up(Months 4, 6, 8, 10, 12)