Establishing a Milk Oriented Microbiota in Healthy Term Infants
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Locations
- 1
- Primary Endpoint
- Infant fecal B. infantis
Study Overview
Brief Summary
The purpose of this study is to determine if supplementing healthy term infants delivered vaginally who consume breast milk, formula, or both with a probiotic for 21 consecutive days increases levels of bacteria in infants' stool.
Detailed Description
The purpose of phase 1 of this two phase clinical trial is to determine: 1) the effect of decreasing levels of human milk oligosaccharides on fecal B.infantis during and after 21 days of supplementation with Evolve activated B.infantis using exclusively breastfed, mixed-fed and exclusively formula-fed infants; 2) determine the effect of Evolve activated B.infantis on fecal B.infantis levels in exclusively breastfed infants compared to pre-supplementation levels.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Women with infants age 8 to 12 weeks
- •Term infants born >37 weeks gestation
- •Mother-infant pairs who live within a 20-mile radius from UC Davis campus in Davis, CA or within a 20-mile UCDMC
- •Women and infants who live in one location
- •Infants born vaginally
- •Infants who are either exclusively formula-fed, exclusively breastfed or mixed-fed
- •Women who are mixed and formula feeding their infants who are willing to switch infant formulas and use the study's infant formula (Earth's Best Organic Infant Formula With Iron, Earth's Best) throughout the first two months of the study
- •Women who are breastfeeding but introduce infant formula to their infants during the first two months of the study who are willing to use the study's infant formula (Earth's Best Organic Infant Formula With Iron, Earth's Best) for the first two months of the study
Exclusion Criteria
- •Women who have lived in the United States or other developed nation for less than 10 consecutive years
- •Multiple infants born to one mother
- •Plan to feed infants solid foods before infants turn 5 months of age
- •Family history of cow milk or soy allergy and/or infants allergic to cow milk protein or soy
- •Infants born by C-section
- •Infants born with medical complications such as: respiratory distress syndrome, birth defects, and infection
- •Infants who have taken antibiotics 4 weeks before enrollment and more than one course of antibiotics since birth
- •Infants who have taken probiotics since birth
- •Plan to administer probiotics to infants or use of probiotics other than the study supplement by infants for the first two months of the study
- •Mothers who have a chronic metabolic disease or obesity
- •Mothers who currently smoke or plan to resume smoking during the study period
- •Infants who consume solid foods or other liquids other than breastmilk, infant formula or water
Arms & Interventions
Mixed fed
Mixed feeding is defined at screening as infants who consume a combination of infant formula and breast milk between day 7 of life through the end on the Lead-in period. Infants will consume B. infantis for twenty-one consecutive days.
Intervention: Bifidobacterium (Dietary Supplement)
Exclusively formula fed
Exclusive formula feeding is defined at screening as infants who consume only infant formula between day 7 of life through the end on the Lead-in period. Infants will consume B. infantis for twenty-one consecutive days.
Intervention: Bifidobacterium (Dietary Supplement)
Exclusively breastfed
Exclusive breastfeeding will be defined at screening as infants who have not consumed any infant formula after 7 days postnatal and have been exclusively breastfed without formula between day 7 of life through the end on the Lead-in period. ). Infants will consume B. infantis for twenty-one consecutive days.
Intervention: Bifidobacterium (Dietary Supplement)
Outcomes
Primary Outcomes
Infant fecal B. infantis
Time Frame: Change from baseline to day 280
The change in infant fecal B. infantis before, during and after supplementation.
Infant fecal Bifidobacterium
Time Frame: Change from baseline to day 280
The change in infant fecal Bifidobacterium before, during, and after supplementation.
Infant fecal total bacteria
Time Frame: Change from baseline to day 280
The change in infant fecal total bacteria before, during and after supplementation.
Infant fecal microbiome
Time Frame: Change from baseline to day 280
The change in infant fecal microbiome before, during and after supplementation.
Infant gastrointestinal symptoms
Time Frame: Change from baseline to day 50
Gastrointestinal symptoms and related symptoms (discomfort passing bowel movements, vomiting, constipation, colic or irritability) before, during and after supplementation will be determined and reported daily by parental self-report questionnaire.
Infant health status
Time Frame: Change from baseline to day 280
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 Outcomes
- Maternal secretor status(Change from baseline to day 280)
- Infant fecal sialic acid concentrations(Change from baseline to day 280)
- Infant fecal microbiome and lifestyle(Change from baseline to day 280)
- Infant weight(Change from baseline to day 280)
- Infant fecal short chain fatty acids(Change from baseline to day 280)
- Infant gastrointestinal function(Change from baseline to day 280)