Clinical trial NCT03222804: Milk Oriented Microbiota
Official title: Establishing a Milk Oriented Microbiota in Healthy Term Infants
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Microbial Colonization
Keywords: Infants
Probiotic
B. Infantis
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Evolve BioSystems, Inc.
First posted: 2017-07-19
Enrollment: 0
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The feeding patterns of eighty eligible infants (8 to 12 weeks in age) will be characterized based on a 7-day diet record that will be filled out by their mothers during the 7-day lead-in period starting with Day -7 and ending with Day -1. Of the eighty infants, twenty will be exclusive breast feeders (BF), twenty will be exclusive formula feeders (FF) and forty will be mixed-feeders (MF). Infants in all three feeding groups will consume B. infantis for twenty-one consecutive days. Participants will then enter the observational phase until their infant turns 1 year old.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Infant fecal B. infantis
timeFrame: Change from baseline to day 280
measure: Infant fecal Bifidobacterium
timeFrame: Change from baseline to day 280
measure: Infant fecal total bacteria
timeFrame: Change from baseline to day 280
measure: Infant fecal microbiome
timeFrame: Change from baseline to day 280
measure: Infant gastrointestinal symptoms
timeFrame: Change from baseline to day 50
measure: Infant health status
timeFrame: Change from baseline to day 280
Secondary outcomes:
measure: Maternal secretor status
timeFrame: Change from baseline to day 280
measure: Infant fecal sialic acid concentrations
timeFrame: Change from baseline to day 280
measure: Infant fecal microbiome and lifestyle
timeFrame: Change from baseline to day 280
measure: Infant weight
timeFrame: Change from baseline to day 280
measure: Infant fecal short chain fatty acids
timeFrame: Change from baseline to day 280
measure: Infant gastrointestinal function
timeFrame: Change from baseline to day 280
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis Medical Center
state: California
Study officials:
affiliation: University of California, Davis
name: Jennifer Smilowitz, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Davis
name: Mark Underwood, MD
role: PRINCIPAL_INVESTIGATOR
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