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OpenTrials
Completed

NCT Number: NCT00331994

EFESO - EFficacy Enterogermina Small Intestinal Bacterial Overgrowth

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.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis Administrative Office

Milan, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bacillus clausii

Drug

3 bacillus clausii vials/day for one month

Metronidazole

Drug

3 Metronidazole tablets/day for one week

Primary outcomes

  1. eradication rate of the small intestinal bacterial overgrowth

    Time frame: 30 days after the end of the treatment.

Secondary outcomes

  1. avoiding recurrence of the small intestinal bacterial overgrowth

    Time frame: 90 days after the end of the treatment.

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
May 31, 2006
Registry last updated
Jul 20, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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