Infant Microbiota and Probiotic Intake Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Infant Supplementation With Probiotic Bifidobacterium Longum Subsp. Infantis Study

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Bifidobacterium


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supplement Group<br>This group will receive probiotic B. infantis supplementation, plus standard care and lactation consultation. | Dietary Supplement: Bifidobacterium<br> <br> * Other names: B. infantis;|
| No Intervention: Control Group<br>This group will receive standard care plus lactation consultation only. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant fecal B. infantis | Measure the change from baseline, during supplementation, and post supplementation | 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 | 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 | 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 | 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. | 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. | Months 4, 6, 8, 10, 12, 18 and 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 | baseline, day 60 | 
| Infant weight | Determine the change in weight across the study duration using a digital infant scale and change in gut microbiota | 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. | 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. | Baseline-days 60 | 
| Fecal lipopolysaccharide | Compare GI function between infants in the B. infantis and control groups through the measurement of fecal lipopolysaccharide binding. | Baseline-days 60 | 
| Fecal short-chain fatty acids | Determine the relationship between fecal microbiota composition and fecal short chain fatty acids | Baseline-days 60 | 
| Fecal microbiome-Follow-up | next generation sequencing | Months 4, 6, 8, 10, 12 | 
| Fecal B. infantis-Follow-up | Q Polymerase Chain Reaction (PCR) | Months 4, 6, 8, 10, 12 | 
| Fecal Bifidobacterium-Follow-up | Q PCR | Months 4, 6, 8, 10, 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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C-section, Infants, Probiotic, B. infantis, Microbiota, Gut, Breast milk, Vaginal