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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
  Purpose

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.


Condition Intervention Phase
Irritable Bowel Syndrome
 Drug: Bacillus clausii
Drug: Metronidazole
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy Evaluation of Enterogermina, 2 Billion Bacillus Clausii Spores, on Eradication of Small Intestinal Bacterial Overgrowth: a Randomised, Parallel-group, Open Study.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

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

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

Enrollment: 250
Study Start Date: April 2006
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00331994

Locations
Italy
Sanofi-Aventis Administrative Office
Milan, Italy
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Georges Paizis, MD Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Medical Director, Sanofi-aventis aministrative office
ClinicalTrials.gov Identifier: NCT00331994     History of Changes
Other Study ID Numbers: PM_L_0161, EudraCT # : 2005-004934-42
Study First Received: May 30, 2006
Last Updated: July 17, 2009
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metronidazole
 Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on May 22, 2013