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EFESO - EFficacy Enterogermina Small Intestinal Bacterial Overgrowth

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00331994
Recruitment Status : Completed
First Posted : May 31, 2006
Last Update Posted : July 20, 2009
Sponsor:
Information provided by:
Sanofi

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.


Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Drug: Bacillus clausii Drug: Metronidazole Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : April 2006
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. eradication rate of the small intestinal bacterial overgrowth [ Time Frame: 30 days after the end of the treatment. ]

Secondary Outcome Measures :
  1. avoiding recurrence of the small intestinal bacterial overgrowth [ Time Frame: 90 days after the end of the treatment. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00331994


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

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Responsible Party: Medical Affairs Medical Director, Sanofi-aventis aministrative office
ClinicalTrials.gov Identifier: NCT00331994    
Other Study ID Numbers: PM_L_0161
EudraCT # : 2005-004934-42
First Posted: May 31, 2006    Key Record Dates
Last Update Posted: July 20, 2009
Last Verified: July 2009
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metronidazole
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents