Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 11:56 PM
Study NCT ID:
NCT00331994
Status:
COMPLETED
Last Update Posted:
2009-07-20
First Post:
2006-05-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
EFESO - EFficacy Enterogermina Small Intestinal Bacterial Overgrowth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}], 'ancestors': [{'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C545326', 'term': 'clausin peptide, Bacillus clausii'}, {'id': 'D008795', 'term': 'Metronidazole'}], 'ancestors': [{'id': 'D009593', 'term': 'Nitroimidazoles'}, {'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-07-17', 'studyFirstSubmitDate': '2006-05-30', 'studyFirstSubmitQcDate': '2006-05-30', 'lastUpdatePostDateStruct': {'date': '2009-07-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-05-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'eradication rate of the small intestinal bacterial overgrowth', 'timeFrame': '30 days after the end of the treatment.'}], 'secondaryOutcomes': [{'measure': 'avoiding recurrence of the small intestinal bacterial overgrowth', 'timeFrame': '90 days after the end of the treatment.'}]}, 'conditionsModule': {'conditions': ['Irritable Bowel Syndrome']}, 'descriptionModule': {'briefSummary': '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.\n\nSecondary 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Irritable bowel syndrome patients with small intestinal bacterial overgrowth (based on positive lactulose or glucose hydrogen breath test)\n* Patients able to maintain their usual diet and lifestyle during the course of the study.\n\nExclusion criteria:\n\n* Pregnancy or breast-feeding\n* Major concomitant diseases (including tumours and hepatic and/or renal insufficiency)\n* Inflammatory bowel diseases\n* History of intestinal surgery (except cholecystectomy and appendectomy)\n* Use of antibiotic, laxative, antidiarrheic drugs or probiotics (medications or dietetic supplements) in the last month prior to study entry\n* Hypersensibility to the investigational product and reference drug\n* 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\n* 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\n* Participation to a trial in the previous three months\n* Drug or alcohol abuse\n* Subjects with unstable personality or not able to be compliant with the study procedures\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT00331994', 'briefTitle': 'EFESO - EFficacy Enterogermina Small Intestinal Bacterial Overgrowth', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Efficacy Evaluation of Enterogermina, 2 Billion Bacillus Clausii Spores, on Eradication of Small Intestinal Bacterial Overgrowth: a Randomised, Parallel-group, Open Study.', 'orgStudyIdInfo': {'id': 'PM_L_0161'}, 'secondaryIdInfos': [{'id': 'EudraCT # : 2005-004934-42'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Bacillus clausii']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Metronidazole']}], 'interventions': [{'name': 'Bacillus clausii', 'type': 'DRUG', 'description': '3 bacillus clausii vials/day for one month', 'armGroupLabels': ['1']}, {'name': 'Metronidazole', 'type': 'DRUG', 'description': '3 Metronidazole tablets/day for one week', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Milan', 'country': 'Italy', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'overallOfficials': [{'name': 'Georges Paizis, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Medical Affairs Medical Director', 'oldOrganization': 'Sanofi-aventis aministrative office'}}}}