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Infant Microbiota and Probiotic Intake Study (IMPRINT)

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ClinicalTrials.gov Identifier: NCT02457338
Recruitment Status : Active, not recruiting
First Posted : May 29, 2015
Last Update Posted : April 23, 2019
Sponsor:
Collaborator:
Evolve BioSystems, Inc.
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Bifidobacterium Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Infant Supplementation With Probiotic Bifidobacterium Longum Subsp. Infantis Study
Study Start Date : November 2014
Estimated Primary Completion Date : June 2027
Estimated Study Completion Date : June 2027

Arm Intervention/treatment
Experimental: Supplement Group
This group will receive probiotic B. infantis supplementation, plus standard care and lactation consultation.
Dietary Supplement: Bifidobacterium
Other Name: B. infantis

No Intervention: Control Group
This group will receive standard care plus lactation consultation only.



Primary Outcome Measures :
  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 Outcome Measures :
  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 lipolysaccharide 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 PCR

  11. Fecal Bifidobacterium-Follow-up [ Time Frame: Months 4, 6, 8, 10, 12 ]
    Q PCR



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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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 UCDMC or a 20-mile radius from UC Davis Campus in Davis, CA
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02457338


Locations
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United States, California
University of California, Davis Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Evolve BioSystems, Inc.
Investigators
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Principal Investigator: Jennifer Smilowitz, PhD University of California, Davis
Principal Investigator: Mark Underwood, MD University of California, Davis

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT02457338     History of Changes
Other Study ID Numbers: 631099
First Posted: May 29, 2015    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019

Keywords provided by University of California, Davis:
C-section
Infants
Probiotic
B. infantis
Microbiota
Gut
Breast milk
Vaginal