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Infant Microbiota and Probiotic Intake Study

NCT02457338 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-12-05

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DIETARY_SUPPLEMENT

Bifidobacterium

Sponsors & Collaborators

  • Evolve BioSystems, Inc.

    collaborator INDUSTRY

  • University of California, Davis

    lead OTHER

Principal Investigators

  • Jennifer Smilowitz, PhD · University of California, Davis

  • Mark Underwood, MD · University of California, Davis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-11-01
Primary Completion
2016-07-15
Completion
2027-06-07

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02457338 on ClinicalTrials.gov