|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT00331994 |
|
Date of registration:
|
30/05/2006 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
EFESO - EFficacy Enterogermina Small Intestinal Bacterial Overgrowth
|
|
Scientific title:
|
Efficacy Evaluation of Enterogermina, 2 Billion Bacillus Clausii Spores, on Eradication of Small Intestinal Bacterial Overgrowth: a Randomised, Parallel-group, Open Study. |
|
Date of first enrolment:
|
April 2006 |
|
Target sample size:
|
250 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00331994 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
Italy
| | | | | | | |
|
Contacts
|
|
Name:
|
Georges Paizis, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Sanofi |
| | |
|
Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Irritable Bowel Syndrome
|
|
Intervention(s)
|
|
Drug: Metronidazole
|
|
Drug: Bacillus clausii
|
|
Primary Outcome(s)
|
|
eradication rate of the small intestinal bacterial overgrowth
[Time Frame: 30 days after the end of the treatment.]
|
|
Secondary Outcome(s)
|
|
avoiding recurrence of the small intestinal bacterial overgrowth
[Time Frame: 90 days after the end of the treatment.]
|
|
Secondary ID(s)
|
|
PM_L_0161
|
|
EudraCT # : 2005-004934-42
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|