Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00331994
Status:
COMPLETED
Last Update Posted:
2009-07-20
First Post:
2006-05-30
Brief Title:
EFESO - EFficacy Enterogermina Small Intestinal Bacterial Overgrowth
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Efficacy Evaluation of Enterogermina 2 Billion Bacillus Clausii Spores on Eradication of Small Intestinal Bacterial Overgrowth a Randomised Parallel-group Open Study
Status:
COMPLETED
Status Verified Date:
2009-07
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:
None
Brief Summary:
Primary objective to assess the efficacy of Bacillus clausii versus metronidazole in the eradication of the small intestinal bacterial overgrowth 30 days after the end of treatment
Secondary objective to assess the efficacy of Bacillus clausii versus metronidazole in avoiding recurrence of the small intestinal bacterial overgrowth 90 days after the end of the treatment to assess the efficacy of Bacillus clausiiversus metronidazole in improving irritable bowel syndrome -related symptoms to assess the efficacy of Bacillus clausii versus metronidazole in the satisfactory relief of overall irritable bowel syndrome symptoms and of abdominal discomfort or pain to assess the efficacy of Bacillus clausii versus metronidazole in improving irritable bowel syndrome quality of life
Secondary objective to assess the efficacy of Bacillus clausii versus metronidazole in avoiding recurrence of the small intestinal bacterial overgrowth 90 days after the end of the treatment to assess the efficacy of Bacillus clausiiversus metronidazole in improving irritable bowel syndrome -related symptoms to assess the efficacy of Bacillus clausii versus metronidazole in the satisfactory relief of overall irritable bowel syndrome symptoms and of abdominal discomfort or pain to assess the efficacy of Bacillus clausii versus metronidazole in improving irritable bowel syndrome quality of life
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EudraCT 2005-004934-42 | None | None | None |