EFESO - EFficacy Enterogermina Small Intestinal Bacterial... | NCT00331994

Studies
EFESO - EFficacy Enterogermina Small Intestinal Bacterial Overgrowth

NCT00331994

Sponsor

Sanofi

Status

Completed

Last Update Posted

Jul 20, 2009Estimated

Enrollment

250Actual

Phase

Phase 4

Conditions

Irritable Bowel Syndrome

Interventions

Bacillus clausii
Metronidazole

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EudraCT # : 2005-004934-42

Status Module

Record Verification Date

Jul 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2006

Primary Completion Date

Jul 2008Actual

Completion Date

Jul 2008Actual

First Submitted Date

May 30, 2006

First Submission Date that Met QC Criteria

May 30, 2006

First Posted Date

May 31, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 17, 2009

Last Update Posted Date

Jul 20, 2009Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

250Actual

Label	Type	Description	Intervention Names
1	Experimental		Drug: Bacillus clausii
2	Active Comparator		Drug: Metronidazole

Name	Type	Description	Arm Group Labels	Other Names
Bacillus clausii	Drug	3 bacillus clausii vials/day for one month	1

Measure	Description	Time Frame
eradication rate of the small intestinal bacterial overgrowth		30 days after the end of the treatment.

Measure	Description	Time Frame
avoiding recurrence of the small intestinal bacterial overgrowth		90 days after the end of the treatment.

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D003109	Colonic Diseases, Functional
D003108	Colonic Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases

ID	Term
C545326	clausin peptide, Bacillus clausii
D008795	Metronidazole

ID	Term
D009593	Nitroimidazoles
D009574	Nitro Compounds
D009930	Organic Chemicals
D007093	Imidazoles