Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-31 @ 2:09 AM
Study NCT ID:
NCT00265369
Status:
COMPLETED
Last Update Posted:
2011-01-11
First Post:
2005-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TEDDY: Spores of Bacillus Clausii in Acute Diarrhoea in Children
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
Comparative Efficacy and Safety of a Bacillus Clausii Probiotic Strain Versus Placebo in the Treatment of Acute Diarrhoea in Children
Status:
COMPLETED
Status Verified Date:
2011-01
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:
None
Brief Summary:
Primary objective:
* To demonstrate the efficacy of a Bacillus clausii probiotic strain compared to placebo in children suffering from acute diarrhoea and treated for 7 days.
Secondary objective:
* To evaluate the clinical safety of the Bacillus clausii probiotic strain versus placebo.
* To demonstrate the efficacy of a Bacillus clausii probiotic strain compared to placebo in children suffering from acute diarrhoea and treated for 7 days.
Secondary objective:
* To evaluate the clinical safety of the Bacillus clausii probiotic strain versus placebo.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: