Milk Oriented Microbiota (MOM)

University of California (UC) Davis

Status: Withdrawn

Conditions: Microbial Colonization

Treatments: Dietary Supplement: Bifidobacterium

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03222804

738191

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 21 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Exclusively breastfed

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Bifidobacterium

Exclusively formula fed

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Bifidobacterium

Mixed fed

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Bifidobacterium