EFESO - EFficacy Enterogermina Small Intestinal Bacterial Overgrowth

This study has been completed.

Sponsor:

Information provided by:

Sanofi

ClinicalTrials.gov Identifier:

NCT00331994

First received: May 30, 2006

Last updated: July 17, 2009

Last verified: July 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

May 30, 2006

Last Updated Date

July 17, 2009

Start Date ^ICMJE

April 2006

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

eradication rate of the small intestinal bacterial overgrowth [ Time Frame: 30 days after the end of the treatment. ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

eradication rate of the small intestinal bacterial overgrowth
30 days after the end of the treatment.

Change History

Complete list of historical versions of study NCT00331994 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

avoiding recurrence of the small intestinal bacterial overgrowth [ Time Frame: 90 days after the end of the treatment. ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

avoiding recurrence of the small intestinal bacterial overgrowth 90 days after the end of the treatment.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

EFESO - EFficacy Enterogermina Small Intestinal Bacterial Overgrowth

Official Title ^ICMJE

Efficacy Evaluation of Enterogermina, 2 Billion Bacillus Clausii Spores, on Eradication of Small Intestinal Bacterial Overgrowth: a Randomised, Parallel-group, Open Study.

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Irritable Bowel Syndrome

Intervention ^ICMJE

Drug: Bacillus clausii
3 bacillus clausii vials/day for one month
Drug: Metronidazole
3 Metronidazole tablets/day for one week

Study Arm (s)

Experimental: 1
Intervention: Drug: Bacillus clausii
Active Comparator: 2
Intervention: Drug: Metronidazole

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

250

Completion Date

July 2008

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion criteria:

Irritable bowel syndrome patients with small intestinal bacterial overgrowth (based on positive lactulose or glucose hydrogen breath test)
Patients able to maintain their usual diet and lifestyle during the course of the study.

Exclusion criteria:

Pregnancy or breast-feeding
Major concomitant diseases (including tumours and hepatic and/or renal insufficiency)
Inflammatory bowel diseases
History of intestinal surgery (except cholecystectomy and appendectomy)
Use of antibiotic, laxative, antidiarrheic drugs or probiotics (medications or dietetic supplements) in the last month prior to study entry
Hypersensibility to the investigational product and reference drug
Clinical evidence of relevant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematologic, neurologic or of any disease that may interfere with the patient successfully completing the trial or the objectives of the trial
Eating disorders such as anorexia or bulimia, and/or psychosis, schizophrenia, mania or major psychiatric illness needing pharmacological treatment. Well-compensated depression does not exclude a potential patient
Participation to a trial in the previous three months
Drug or alcohol abuse
Subjects with unstable personality or not able to be compliant with the study procedures

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Italy

Administrative Information

NCT Number ^ICMJE

NCT00331994

Other Study ID Numbers ^ICMJE

PM_L_0161, EudraCT # : 2005-004934-42

Has Data Monitoring Committee

Not Provided

Responsible Party

Medical Affairs Medical Director, Sanofi-aventis aministrative office

Study Sponsor ^ICMJE

Sanofi

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Georges Paizis, MD

Sanofi

Information Provided By

Sanofi

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top