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Gastrointestinal Tolerance And General Health Status Of Healthy Term Infants Fed A New Infant Formula

NCT01370967 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 460

Last updated 2013-12-24

No results posted yet for this study

Summary

The purpose of this study is to assess stool consistency, in combination with additional health-related parameters including gastrointestinal tolerance and health-related quality of life, in a large sample of Chinese infants. We will also assess the timing of, frequency, and reasons for changes in the choice of formula or method of feeding among infants in this sample, as well as incidence of common infant illness and associated healthcare usage. Anthropometric measures and the frequency and duration of physician- and parent-reported gastrointestinal and other adverse events will be evaluated.

Conditions

  • Healthy

Interventions

OTHER

Study formula feeding

Infants who are exclusively fed the new study formula at time of enrollment

OTHER

Human milk feeding

Infants who are exclusively fed human milk at time of enrollment

OTHER

Mixed feeding

Infants who are exclusively fed human milk and the new study formula at time of enrollment

Sponsors & Collaborators

  • Société des Produits Nestlé (SPN)

    lead INDUSTRY

Eligibility

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

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • China

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 NCT01370967 on ClinicalTrials.gov