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

Active, not recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

120

Phase

  • 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

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
Intervention / Treatment
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

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

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

University of California, Davis

Collaborators

Evolve BioSystems, Inc.

Investigators

  • 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)

November 1, 2014

Primary Completion (Actual)

July 15, 2016

Study Completion (Estimated)

June 7, 2027

Study Registration Dates

First Submitted

May 27, 2015

First Submitted That Met QC Criteria

May 28, 2015

First Posted (Estimated)

May 29, 2015

Study Record Updates

Last Update Posted (Estimated)

December 5, 2025

Last Update Submitted That Met QC Criteria

December 3, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID 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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