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Milk Oriented Microbiota (MOM)

Primary Purpose

Microbial Colonization

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Bifidobacterium

About this trial

This is an interventional other trial for Microbial Colonization focused on measuring Infants, Probiotic, B. Infantis

Eligibility Criteria

21 Years - 45 Years (Adult)FemaleAccepts 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

Sites / Locations

University of California, Davis Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Exclusively breastfed

Exclusively formula fed

Mixed fed

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

Infant fecal B. infantis

The change in infant fecal B. infantis before, during and after supplementation.

Infant fecal Bifidobacterium

The change in infant fecal Bifidobacterium before, during, and after supplementation.

Infant fecal total bacteria

The change in infant fecal total bacteria before, during and after supplementation.

Infant fecal microbiome

The change in infant fecal microbiome before, during and after supplementation.

Infant gastrointestinal symptoms

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

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 Outcome Measures

Maternal secretor status

Determine the relationship between human milk oligosaccharides in breast milk and infant fecal microbiome.

Infant fecal sialic acid concentrations

The change in infant fecal sialic acid and fucose concentrations before, during and after supplementation in infant stool samples.

Infant fecal microbiome and lifestyle

Determine the relationship between the following factors determined by self-report questionnaires: parity, maternal and infant antibiotic intake and maternal use of antimicrobials, infant intake of formula; and the change infant fecal microbiome.

Infant weight

Determine the relationship between infant weight and change in fecal microbiome.

Infant fecal short chain fatty acids

Determine the relationship between fecal short chain fatty acids and fecal microbiome.

Infant gastrointestinal function

Determine the relationship between GI function (fecal inflammatory, GI barrier mediators, LPS) and fecal microbiome.

Full Information

NCT ID

NCT03222804

First Posted

July 7, 2017

Last Updated

March 9, 2018

Sponsor

University of California, Davis

Collaborators

Evolve BioSystems, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03222804

Brief Title

Milk Oriented Microbiota

Acronym

MOM

Official Title

Establishing a Milk Oriented Microbiota in Healthy Term Infants

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Withdrawn

Why Stopped

Withdrawn due to loss of funding

Study Start Date

May 2017 (Anticipated)

Primary Completion Date

March 6, 2018 (Actual)

Study Completion Date

March 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, Davis

Collaborators

Evolve BioSystems, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Microbial Colonization

Keywords

Infants, Probiotic, B. Infantis

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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.

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Exclusively breastfed

Arm Type

Active Comparator

Arm Description

Arm Title

Exclusively formula fed

Arm Type

Active Comparator

Arm Description

Arm Title

Mixed fed

Arm Type

Active Comparator

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

Bifidobacterium

Other Intervention Name(s)

B. infantis

Intervention Description

Each B. infantis (strain: BIEVC001) dose will be provided in one 625 mg sachet delivering 156 mg of live bacteria at a dose of 9x10^9 CFU plus 469 mg of pharmaceutical-grade lactose as the excipient and dispensed to participants by the study personnel.

Primary Outcome Measure Information:

Title

Infant fecal B. infantis

Description

The change in infant fecal B. infantis before, during and after supplementation.

Time Frame

Change from baseline to day 280

Title

Infant fecal Bifidobacterium

Description

The change in infant fecal Bifidobacterium before, during, and after supplementation.

Time Frame

Change from baseline to day 280

Title

Infant fecal total bacteria

Description

The change in infant fecal total bacteria before, during and after supplementation.

Time Frame

Change from baseline to day 280

Title

Infant fecal microbiome

Description

The change in infant fecal microbiome before, during and after supplementation.

Time Frame

Change from baseline to day 280

Title

Infant gastrointestinal symptoms

Description

Time Frame

Change from baseline to day 50

Title

Infant health status

Description

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

Change from baseline to day 280

Secondary Outcome Measure Information:

Title

Maternal secretor status

Description

Determine the relationship between human milk oligosaccharides in breast milk and infant fecal microbiome.

Time Frame

Change from baseline to day 280

Title

Infant fecal sialic acid concentrations

Description

The change in infant fecal sialic acid and fucose concentrations before, during and after supplementation in infant stool samples.

Time Frame

Change from baseline to day 280

Title

Infant fecal microbiome and lifestyle

Description

Time Frame

Change from baseline to day 280

Title

Infant weight

Description

Determine the relationship between infant weight and change in fecal microbiome.

Time Frame

Change from baseline to day 280

Title

Infant fecal short chain fatty acids

Description

Determine the relationship between fecal short chain fatty acids and fecal microbiome.

Time Frame

Change from baseline to day 280

Title

Infant gastrointestinal function

Description

Determine the relationship between GI function (fecal inflammatory, GI barrier mediators, LPS) and fecal microbiome.

Time Frame

Change from baseline to day 280

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jennifer Smilowitz, PhD

Organizational Affiliation

University of California, Davis

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Mark Underwood, MD

Organizational Affiliation

University of California, Davis

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of California, Davis Medical Center

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

12. IPD Sharing Statement

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Milk Oriented Microbiota

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