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NCT Number: NCT02457338

Infant Microbiota and Probiotic Intake 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Healthy

Age range

21 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Davis Medical Center

Sacramento, California, 95817, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bifidobacterium

Dietary Supplement

Other names: B. infantis

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  6. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. Fecal short-chain fatty acids

    Time frame: Baseline-days 60

    Determine the relationship between fecal microbiota composition and fecal short chain fatty acids

  9. Fecal microbiome-Follow-up

    Time frame: Months 4, 6, 8, 10, 12

    next generation sequencing

  10. Fecal B. infantis-Follow-up

    Time frame: Months 4, 6, 8, 10, 12

    Q Polymerase Chain Reaction (PCR)

  11. Fecal Bifidobacterium-Follow-up

    Time frame: Months 4, 6, 8, 10, 12

    Q PCR

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • Evolve BioSystems, Inc.

Registry information

Official study title

Infant Supplementation With Probiotic Bifidobacterium Longum Subsp. Infantis Study

Acronym: IMPRINT

Important dates

Study start
2014
Primary completion
2016
Study completion
2027
First posted
May 29, 2015
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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