Milk Oriented Microbiota (MOM)

December 6, 2024 updated by: University of California, Davis

Establishing a Milk Oriented Microbiota in Healthy Term Infants

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • University of California, Davis Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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.
Dietary supplement: Bifidobacterium
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.
Other Names:
  • B. infantis
Active Comparator: 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.
Dietary supplement: Bifidobacterium
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.
Other Names:
  • B. infantis
Active Comparator: 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.
Dietary supplement: Bifidobacterium
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.
Other Names:
  • B. infantis

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Infant fecal B. infantis
Time Frame: Change from baseline to day 280
The change in infant fecal B. infantis before, during and after supplementation.
Change from baseline to day 280
Infant fecal Bifidobacterium
Time Frame: Change from baseline to day 280
The change in infant fecal Bifidobacterium before, during, and after supplementation.
Change from baseline to day 280
Infant fecal total bacteria
Time Frame: Change from baseline to day 280
The change in infant fecal total bacteria before, during and after supplementation.
Change from baseline to day 280
Infant fecal microbiome
Time Frame: Change from baseline to day 280
The change in infant fecal microbiome before, during and after supplementation.
Change from baseline to day 280
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.
Change from baseline to day 50
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.
Change from baseline to day 280

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maternal secretor status
Time Frame: Change from baseline to day 280
Determine the relationship between human milk oligosaccharides in breast milk and infant fecal microbiome.
Change from baseline to day 280
Infant fecal sialic acid concentrations
Time Frame: Change from baseline to day 280
The change in infant fecal sialic acid and fucose concentrations before, during and after supplementation in infant stool samples.
Change from baseline to day 280
Infant fecal microbiome and lifestyle
Time Frame: Change from baseline to day 280
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.
Change from baseline to day 280
Infant weight
Time Frame: Change from baseline to day 280
Determine the relationship between infant weight and change in fecal microbiome.
Change from baseline to day 280
Infant fecal short chain fatty acids
Time Frame: Change from baseline to day 280
Determine the relationship between fecal short chain fatty acids and fecal microbiome.
Change from baseline to day 280
Infant gastrointestinal function
Time Frame: Change from baseline to day 280
Determine the relationship between GI function (fecal inflammatory, GI barrier mediators, LPS) and fecal microbiome.
Change from baseline to day 280

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, Davis

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Evolve BioSystems, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jennifer Smilowitz, PhD, University of California, Davis
  • Principal Investigator: Mark Underwood, MD, University of California, Davis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 15, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 16, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 16, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 7, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 19, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 11, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 738191

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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