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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
University of California, Davis Medical Center
Sacramento, California, United States
Infant fecal B. infantis
Measure the change from baseline, during supplementation, and post supplementation
Time frame: baseline, days 10, 14, 17, 21, 25, 29, 32, 40, 50, 60
Infant fecal Bifidobacterium
Measure the change from baseline, during supplementation, and post supplementation
Time frame: baseline, days 10, 14, 17, 21, 25, 29, 32, 40, 50, 60
Infant fecal total bacteria
Measure the change from baseline, during supplementation, and post supplementation
Time frame: baseline, days 10, 14, 17, 21, 25, 29, 32, 40, 50, 60
Infant fecal microbiota
Measure the change from baseline, during supplementation, and post supplementation
Time frame: baseline, days 10, 14, 17, 21, 25, 29, 32, 40, 50, 60
Incidence of Adverse Events and Treatments
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.
Time frame: Baseline-days 60
Incidence of Adverse Events and Treatments
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Months 4, 6, 8, 10, 12, 18 and 24
Infant fecal bacteria oligosaccharide consumption
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.
Time frame: days 7, 14, 21, 32, 60
Infant fecal sialic acid concentrations
Measure the change in infant fecal sialic acid concentrations before, during, and after B. infantis supplementation in infant stool samples using enzymatic assay.
Time frame: baseline, days 10, 14, 17, 21, 25, 29, 32, 40, 50, 60
Maternal fecal B. infantis, Bifidobacterium, total bacteria, and microbiota composition
Compare the maternal fecal B. infantis, bifidobacterium, total bacteria, and microbiota composition with changes in infant fecal microbiota
Time frame: baseline, day 60
Infant weight
Determine the change in weight across the study duration using a digital infant scale and change in gut microbiota
Time frame: birth, hospital discharge, days 15, 33, 61
Fecal inflammatory mediators
Compare GI function between infants in the B. infantis and control groups through the measurement of fecal inflammatory mediators.
Time frame: Baseline-days 60
Fecal gut barrier function barrier markers
Compare GI function between infants in the B. infantis and control groups through the measurement of GI barrier function markers.
Time frame: Baseline-days 60
Fecal lipopolysaccharide
Compare GI function between infants in the B. infantis and control groups through the measurement of fecal lipopolysaccharide binding.
Time frame: Baseline-days 60
Fecal short-chain fatty acids
Determine the relationship between fecal microbiota composition and fecal short chain fatty acids
Time frame: Baseline-days 60
Fecal microbiome-Follow-up
next generation sequencing
Time frame: Months 4, 6, 8, 10, 12
Fecal B. infantis-Follow-up
Q Polymerase Chain Reaction (PCR)
Time frame: Months 4, 6, 8, 10, 12
Fecal Bifidobacterium-Follow-up
Q PCR
Time frame: Months 4, 6, 8, 10, 12