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Exploratory/Proof of Principle Microbiota Study

NCT02500563 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2017-07-28

No results posted yet for this study

Summary

This clinical trial will evaluate the stool of infants fed one of two infant formulas, which contain different types of proteins, or breast milk to determine if different proteins have an effect on the type of bacteria that enters and lives in an infant's intestine early in life.

Conditions

  • Fecal Microbiota

Interventions

OTHER

Amino acid based infant formula

OTHER

Extensively hydrolyzed casein infant formula

OTHER

Mother's own breast milk

Sponsors & Collaborators

  • Midwest Children's Health Research Institute

    collaborator UNKNOWN

  • Mead Johnson Nutrition

    lead INDUSTRY

Principal Investigators

  • Jon Vanderhoof, M.D. · Mead Johnson and Company

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
7 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2017-07-31
Completion
2017-07-31

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 NCT02500563 on ClinicalTrials.gov