Infant Microbiota and Probiotic Intake Study (IMPRINT)

December 3, 2025 updated by: University of California, Davis

Infant Supplementation With Probiotic Bifidobacterium Longum Subsp. Infantis Study

The purpose of this study is to determine if supplementing healthy term infants delivered by C-section or vaginal delivery who only consume breastmilk 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.
Active, not recruiting

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 this clinical trial is to determine the effects of supplementing the probiotic Bifidobacterium longum subsp. infantis for the first 21 days of life in healthy term breastfed infants delivered via C-section or vaginal delivery on gut bacteria composition during, 1 week, and 1 month after supplementation compared with matched-control term infants receiving standard care. The investigators' specific aim is to compare the fecal microbiota (total B. infantis, total Bifidobacterium, total bacteria and composition of microbiota) between the supplement and control groups.

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

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

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:

  • Healthy, non-smoking women and their infants
  • Who are pregnant in their third trimester OR have delivered by C-section or vaginal birth within the past 7 days
  • Patients who live within a 20-mile radius from University of California Davis Medical Center (UCDMC) or a 20-mile radius from UC Davis Campus in Davis, California.
  • Plan to exclusively breastfeed their infants for at least 3 months
  • Infants: 0-7 days old, delivered by C-section or vaginal delivery, born >37 weeks gestation, without medical complications that would preclude breastfeeding or alter gut microbiota

Exclusion Criteria:

  • Infants born with medical complications such as: respiratory distress syndrome, birth defects, and infection
  • Infants who have taken antibiotics for more than 72 hours of life
  • Infants who have consume formula feedings after day 7 of life
  • Mothers and their infants who are not discharged from the hospital by day 4 of life due to complications
  • Plan to administer probiotics to infants or use of probiotics other than the study supplement by infants anytime throughout the study duration
  • Women who have had any breast surgery or injury within the past 5 years that would reduce the chance of successful exclusive breastfeeding
  • Mothers who have a chronic metabolic disease or obesity

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: Treatment
  • Allocation: 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.
Experimental: Supplement Group
This group will receive probiotic B. infantis supplementation, plus standard care and lactation consultation.
Dietary supplement: Bifidobacterium
Other Names:
  • B. infantis
No Intervention: Control Group
This group will receive standard care plus lactation consultation only.

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: baseline, days 10, 14, 17, 21, 25, 29, 32, 40, 50, 60
Measure the change from baseline, during supplementation, and post supplementation
baseline, days 10, 14, 17, 21, 25, 29, 32, 40, 50, 60
Infant fecal Bifidobacterium
Time Frame: baseline, days 10, 14, 17, 21, 25, 29, 32, 40, 50, 60
Measure the change from baseline, during supplementation, and post supplementation
baseline, days 10, 14, 17, 21, 25, 29, 32, 40, 50, 60
Infant fecal total bacteria
Time Frame: baseline, days 10, 14, 17, 21, 25, 29, 32, 40, 50, 60
Measure the change from baseline, during supplementation, and post supplementation
baseline, days 10, 14, 17, 21, 25, 29, 32, 40, 50, 60
Infant fecal microbiota
Time Frame: baseline, days 10, 14, 17, 21, 25, 29, 32, 40, 50, 60
Measure the change from baseline, during supplementation, and post supplementation
baseline, days 10, 14, 17, 21, 25, 29, 32, 40, 50, 60
Incidence of Adverse Events and Treatments
Time Frame: Baseline-days 60
Gastrointestinal symptoms and related symptoms (discomfort passing bowel movements, vomiting, constipation, colic or irritability) before, during and after B. infantis supplementation will be determined and reported daily by parental self-report questionnaire. 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.
Baseline-days 60
Incidence of Adverse Events and Treatments
Time Frame: Months 4, 6, 8, 10, 12, 18 and 24
Gastrointestinal symptoms and related symptoms (diarrhea, vomiting, constipation, colic, irritability) after B. infantis supplementation will be determined and reported parental self-report questionnaire. 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.
Months 4, 6, 8, 10, 12, 18 and 24

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
Infant fecal bacteria oligosaccharide consumption
Time Frame: days 7, 14, 21, 32, 60
Compare the oligosaccharides in human milk against the oligosaccharides in infant feces before, during, and after B. infantis supplementation by using liquid chromatography Chip-TOP mass spectrometry.
days 7, 14, 21, 32, 60
Infant fecal sialic acid concentrations
Time Frame: baseline, days 10, 14, 17, 21, 25, 29, 32, 40, 50, 60
Measure the change in infant fecal sialic acid concentrations before, during, and after B. infantis supplementation in infant stool samples using enzymatic assay.
baseline, days 10, 14, 17, 21, 25, 29, 32, 40, 50, 60
Maternal fecal B. infantis, Bifidobacterium, total bacteria, and microbiota composition
Time Frame: baseline, day 60
Compare the maternal fecal B. infantis, bifidobacterium, total bacteria, and microbiota composition with changes in infant fecal microbiota
baseline, day 60
Infant weight
Time Frame: birth, hospital discharge, days 15, 33, 61
Determine the change in weight across the study duration using a digital infant scale and change in gut microbiota
birth, hospital discharge, days 15, 33, 61
Fecal inflammatory mediators
Time Frame: Baseline-days 60
Compare GI function between infants in the B. infantis and control groups through the measurement of fecal inflammatory mediators.
Baseline-days 60
Fecal gut barrier function barrier markers
Time Frame: Baseline-days 60
Compare GI function between infants in the B. infantis and control groups through the measurement of GI barrier function markers.
Baseline-days 60
Fecal lipopolysaccharide
Time Frame: Baseline-days 60
Compare GI function between infants in the B. infantis and control groups through the measurement of fecal lipopolysaccharide binding.
Baseline-days 60
Fecal short-chain fatty acids
Time Frame: Baseline-days 60
Determine the relationship between fecal microbiota composition and fecal short chain fatty acids
Baseline-days 60
Fecal microbiome-Follow-up
Time Frame: Months 4, 6, 8, 10, 12
next generation sequencing
Months 4, 6, 8, 10, 12
Fecal B. infantis-Follow-up
Time Frame: Months 4, 6, 8, 10, 12
Q Polymerase Chain Reaction (PCR)
Months 4, 6, 8, 10, 12
Fecal Bifidobacterium-Follow-up
Time Frame: Months 4, 6, 8, 10, 12
Q PCR
Months 4, 6, 8, 10, 12

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

Helpful Links

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.
November 1, 2014

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.
July 15, 2016

Study Completion (Estimated)

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.
June 7, 2027

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).
May 27, 2015

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.
May 28, 2015

First Posted (Estimated)

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.
May 29, 2015

Study Record Updates

Last Update Posted (Estimated)

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 5, 2025

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 3, 2025

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, 2025

More Information

Terms related to this study

Keywords

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.
  • 631099

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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