Viewing Study NCT02165956


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Study NCT ID: NCT02165956
Status: COMPLETED
Last Update Posted: 2019-07-19
First Post: 2014-06-11
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Effect of a New Infant Cereal on Weight Gain
Sponsor: Laboratorios Ordesa
Organization:

Study Overview

Official Title: Effect of a New Food Product on Weight Gain During First Infancy
Status: COMPLETED
Status Verified Date: 2019-07
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: CEOBE
Brief Summary: The purpose of this study is to determine whether a new infant cereal has an effect on weight gain and intestinal microbiota compared to a standard cereal in healthy infants .
Detailed Description: This is a multicenter, controlled, randomized, prospective, parallel-group, double-blind study to evaluate the effect of a new infant cereal supplemented with prebiotics, probiotics, vegetable proteins and a special blend of starches on weight gain and intestinal microbiota in healthy infants from 6 to 12 moths of age. Patients will be randomized to receive either the new infant cereal or a standard cereal.

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?: