Healthy
Conditions
Keywords
C-section, Infants, Probiotic, B. infantis, Microbiota, Gut, Breast milk, Vaginal
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.
Interventions
DIETARY_SUPPLEMENTBifidobacterium
Sponsors
Evolve BioSystems, Inc.
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infant fecal B. infantis | 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 | 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 | 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 | baseline, days 10, 14, 17, 21, 25, 29, 32, 40, 50, 60 | Measure the change from baseline, during supplementation, and post supplementation |
| Incidence of Adverse Events and Treatments | Baseline-days 60 | Gastrointestinal symptoms and related symptoms (discomfort passing bowel movements, vomiting, constipation, colic or irritability) before, during and after B. infantis supplementation will be determined and reported daily by 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fecal gut barrier function barrier markers | Baseline-days 60 | Compare GI function between infants in the B. infantis and control groups through the measurement of GI barrier function markers. |
| Fecal lipopolysaccharide | Baseline-days 60 | Compare GI function between infants in the B. infantis and control groups through the measurement of fecal lipopolysaccharide binding. |
| Fecal short-chain fatty acids | Baseline-days 60 | Determine the relationship between fecal microbiota composition and fecal short chain fatty acids |
| Infant fecal bacteria oligosaccharide consumption | days 7, 14, 21, 32, 60 | Compare the oligosaccharides in human milk against the oligosaccharides in infant feces before, during, and after B. infantis supplementation by using liquid chromatography Chip-TOP mass spectrometry. |
| Fecal B. infantis-Follow-up | Months 4, 6, 8, 10, 12 | Q Polymerase Chain Reaction (PCR) |
| Fecal Bifidobacterium-Follow-up | Months 4, 6, 8, 10, 12 | Q PCR |
| Fecal microbiome-Follow-up | Months 4, 6, 8, 10, 12 | next generation sequencing |
| Infant fecal sialic acid concentrations | baseline, days 10, 14, 17, 21, 25, 29, 32, 40, 50, 60 | Measure the change in infant fecal sialic acid concentrations before, during, and after B. infantis supplementation in infant stool samples using enzymatic assay. |
| Maternal fecal B. infantis, Bifidobacterium, total bacteria, and microbiota composition | baseline, day 60 | Compare the maternal fecal B. infantis, bifidobacterium, total bacteria, and microbiota composition with changes in infant fecal microbiota |
| Infant weight | birth, hospital discharge, days 15, 33, 61 | Determine the change in weight across the study duration using a digital infant scale and change in gut microbiota |
| Fecal inflammatory mediators | Baseline-days 60 | Compare GI function between infants in the B. infantis and control groups through the measurement of fecal inflammatory mediators. |
Countries
United States
Outcome results
None listed