EFESO - EFficacy Enterogermina Small Intestinal Bacterial Overgrowth - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00331994

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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:

Drug Information available for: Metronidazole hydrochloride Metronidazole phosphate Metronidazole

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

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
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Bacillus clausii 3 bacillus clausii vials/day for one month
2: Active Comparator	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
Milan, Italy

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Georges Paizis, MD

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	Sanofi-aventis aministrative office ( Medical Affairs Medical Director )
Study ID Numbers:	PM_L_0161, EudraCT # : 2005-004934-42
Study First Received:	May 30, 2006
Last Updated:	September 5, 2008
ClinicalTrials.gov Identifier:	NCT00331994 History of Changes
Health Authority:	Italy: Ministry of Health

Study placed in the following topic categories:

Metronidazole
Digestive System Diseases
Radiation-Sensitizing Agents
Gastrointestinal Diseases

Colonic Diseases
Irritable Bowel Syndrome
Intestinal Diseases
Colonic Diseases, Functional

Additional relevant MeSH terms:

Anti-Infective Agents
Metronidazole
Antiprotozoal Agents
Disease
Gastrointestinal Diseases
Colonic Diseases
Physiological Effects of Drugs
Intestinal Diseases
Pharmacologic Actions

Antiparasitic Agents
Digestive System Diseases
Pathologic Processes
Radiation-Sensitizing Agents
Therapeutic Uses
Syndrome
Irritable Bowel Syndrome
Colonic Diseases, Functional

ClinicalTrials.gov processed this record on July 02, 2009