NCT01370967

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

Gastrointestinal Tolerance And General Health Status Of Healthy Term Infants Fed A New Infant Formula: A Prospective, Observational Cohort Study In China

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 460 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 35 Days – 49 Days
• Healthy volunteers: Accepted

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.

Detailed description

Parents / legally acceptable representatives of eligible infants will be invited to volunteer.

Conditions

• Healthy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-07-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2011-06-10
• Last updated: 2013-12-24

Locations

24 sites across 1 country: China