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EFESO - EFficacy Enterogermina Small Intestinal Bacterial Overgrowth

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Bacillus clausii
Metronidazole
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

eradication rate of the small intestinal bacterial overgrowth

Secondary Outcome Measures

avoiding recurrence of the small intestinal bacterial overgrowth

Full Information

First Posted
May 30, 2006
Last Updated
July 17, 2009
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00331994
Brief Title
EFESO - EFficacy Enterogermina Small Intestinal Bacterial Overgrowth
Official Title
Efficacy Evaluation of Enterogermina, 2 Billion Bacillus Clausii Spores, on Eradication of Small Intestinal Bacterial Overgrowth: a Randomised, Parallel-group, Open Study.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Bacillus clausii
Intervention Description
3 bacillus clausii vials/day for one month
Intervention Type
Drug
Intervention Name(s)
Metronidazole
Intervention Description
3 Metronidazole tablets/day for one week
Primary Outcome Measure Information:
Title
eradication rate of the small intestinal bacterial overgrowth
Time Frame
30 days after the end of the treatment.
Secondary Outcome Measure Information:
Title
avoiding recurrence of the small intestinal bacterial overgrowth
Time Frame
90 days after the end of the treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georges Paizis, MD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Milan
Country
Italy

12. IPD Sharing Statement

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EFESO - EFficacy Enterogermina Small Intestinal Bacterial Overgrowth

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