EFESO - EFficacy Enterogermina Small Intestinal Bacterial Overgrowth

July 17, 2009 updated by: Sanofi

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy
        • Sanofi-Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Bacillus clausii
3 bacillus clausii vials/day for one month
Active Comparator: 2
Drug: Metronidazole
3 Metronidazole tablets/day for one week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
eradication rate of the small intestinal bacterial overgrowth
Time Frame: 30 days after the end of the treatment.
30 days after the end of the treatment.

Secondary Outcome Measures

Outcome Measure
Time Frame
avoiding recurrence of the small intestinal bacterial overgrowth
Time Frame: 90 days after the end of the treatment.
90 days after the end of the treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Director: Georges Paizis, MD, Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

May 30, 2006

First Submitted That Met QC Criteria

May 30, 2006

First Posted (Estimate)

May 31, 2006

Study Record Updates

Last Update Posted (Estimate)

July 20, 2009

Last Update Submitted That Met QC Criteria

July 17, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PM_L_0161
  • EudraCT # : 2005-004934-42

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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