Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-31 @ 7:23 PM
Study NCT ID:
NCT01609634
Status:
COMPLETED
Last Update Posted:
2021-10-18
First Post:
2012-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
New Infant Formula Trial in Healthy Term Subjects on Growth, Body Composition, Tolerance and Safety
Sponsor:
Danone Asia Pacific Holdings Pte, Ltd.
Organization:
Study Overview
Official Title:
A Randomised, Controlled, Double-blind Trial to Investigate the Effects of a New Infant Formula in Healthy Term Subjects on Growth, Body Composition, Tolerance and Safety.
Status:
COMPLETED
Status Verified Date:
2021-10
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:
Venus
Brief Summary:
This study is initiated to investigate the effect of a new infant formula in healthy term subjects on growth, body composition, tolerance and safety.
Detailed Description:
This is a "best after breast design" to measure the effect of this new infant formula in healthy term subjects on growth, body composition, tolerance and safety including immune status, gut microbiota, and early indicators (markers) of disease. These markers will be explored if they could predict the risk of eczema and other allergic disease, and to evaluate if these markers are influenced by early nutrition.
Study Oversight
Has Oversight DMC:
True
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?: