Ignite Creation Date:
2024-05-06 @ 2:22 AM
Last Modification Date:
2024-10-26 @ 11:17 AM
Study NCT ID:
NCT02031003
Status:
COMPLETED
Last Update Posted:
2014-01-09
First Post:
2013-12-23
Brief Title:
Effect of Infant Formulas Containing a New Fat Blend or the New Fat Blend Plus Fiber in Healthy Term Infants
Sponsor:
Société des Produits Nestlé SPN
Organization:
Société des Produits Nestlé SPN
Study Overview
Official Title:
Effect of an Infant Formula With High 2-Palmitic Vegetable Oil or an Identical Formula Supplemented With Oligofructose on Stool Composition and Stool Characteristics in Healthy Term Infants in Taiwan
Status:
COMPLETED
Status Verified Date:
2014-01
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:
9055A1-2000
Brief Summary:
The primary objective of the study was to compare stool composition stool soap and non-soap fatty acids total fatty acids minerals and other stool constituents of infants randomized to receive either standard formula or 1 of 2 innovative formulas containing a new fat blend or the new fat blend plus fiber
The secondary objectives were to evaluate among the feeding groups stool characteristics stool consistency and frequency GI tolerance assessed by the Infant Gastrointestinal Symptom Questionnaire IGSQ and urinary markers F2-isoprostanes and 8-hydroxy-2-deoxyguanosine 8-OHdG and urine osmolality and specific gravity
The primary safety objective was to describe the frequency of adverse events AEs among the formula-fed FF groups
The secondary safety objective was to describe anthropometric measures weight length and head circumference among the feeding groups
The secondary objectives were to evaluate among the feeding groups stool characteristics stool consistency and frequency GI tolerance assessed by the Infant Gastrointestinal Symptom Questionnaire IGSQ and urinary markers F2-isoprostanes and 8-hydroxy-2-deoxyguanosine 8-OHdG and urine osmolality and specific gravity
The primary safety objective was to describe the frequency of adverse events AEs among the formula-fed FF groups
The secondary safety objective was to describe anthropometric measures weight length and head circumference among the feeding groups
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None