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Nutritive Effects of Prebiotics on Early Postnatal Behavioral Measures of Tolerance

NCT02118935 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 161

Last updated 2016-06-24

No results posted yet for this study

Summary

The study is intended to measure infant comfort, behavior, and sleep when consuming study formula with prebiotics compared to infants who consume a study formula without the prebiotics.

Conditions

  • Behavioral Measures of Tolerance

Interventions

OTHER

Previously marketed cow's mlik-based infant formula

OTHER

Marketed cow's milk-based infant formula with prebiotics

Sponsors & Collaborators

  • University of Kansas Medical Center

    collaborator OTHER

  • Mead Johnson Nutrition

    lead INDUSTRY

Principal Investigators

  • Carol Lynn Berseth, MD · Mead Johnson Nutrition

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
14 Days
Max Age
35 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2016-03-31
Completion
2016-03-31

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 NCT02118935 on ClinicalTrials.gov