NCT00331994

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2006

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 31, 2006

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

July 20, 2009

Status Verified

July 1, 2009

Enrollment Period

2.3 years

First QC Date

May 30, 2006

Last Update Submit

July 17, 2009

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

  • eradication rate of the small intestinal bacterial overgrowth

    30 days after the end of the treatment.

Secondary Outcomes (1)

  • avoiding recurrence of the small intestinal bacterial overgrowth

    90 days after the end of the treatment.

Study Arms (2)

1

EXPERIMENTAL
Drug: Bacillus clausii

2

ACTIVE COMPARATOR
Drug: Metronidazole

Interventions

Bacillus clausiiDRUG

3 bacillus clausii vials/day for one month

1
MetronidazoleDRUG

3 Metronidazole tablets/day for one week

2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis Administrative Office

Milan, Italy

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

clausin peptide, Bacillus clausiiMetronidazole

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

NitroimidazolesNitro CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Georges Paizis, MD

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 30, 2006

First Posted

May 31, 2006

Study Start

April 1, 2006

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

July 20, 2009

Record last verified: 2009-07

Locations

IT(1)