Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:48 PM
Study NCT ID:
NCT01370967
Status:
COMPLETED
Last Update Posted:
2013-12-24
First Post:
2011-06-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Gastrointestinal Tolerance And General Health Status Of Healthy Term Infants Fed A New Infant Formula
Sponsor:
Société des Produits Nestlé (SPN)
Organization:
Study Overview
Official Title:
Gastrointestinal Tolerance And General Health Status Of Healthy Term Infants Fed A New Infant Formula: A Prospective, Observational Cohort Study In China
Status:
COMPLETED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: