EFESO - EFficacy Enterogermina Small Intestinal Bacterial Overgrowth
Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Irritable Bowel Syndrome
Intervention: Bacillus clausii (Drug); Metronidazole (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Sanofi-Aventis Official(s) and/or principal investigator(s):
Georges Paizis, MD, Study Director, Affiliation: Sanofi-Aventis
Overall contact:
Public Registry GMA, Email: publicregistrygma@sanofi-aventis.com
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.
Clinical Details
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 design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: eradication rate of the small intestinal bacterial overgrowth
Secondary outcome: avoiding recurrence of the small intestinal bacterial overgrowth
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Public Registry GMA, Email: publicregistrygma@sanofi-aventis.com
Sanofi-aventis, Milan, Italy; Recruiting
Additional Information
Starting date: April 2006
Last updated: April 17, 2008
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