Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-27 @ 11:40 PM
Study NCT ID:
NCT01275560
Status:
COMPLETED
Last Update Posted:
2015-06-03
First Post:
2011-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does the Negativation of the Glucose Hydrogen Breath Test Come Along With a Reduction of the Symptoms of Gaz Incontinence ?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004688', 'term': 'Encopresis'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019960', 'term': 'Elimination Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-02', 'studyFirstSubmitDate': '2011-01-11', 'studyFirstSubmitQcDate': '2011-01-11', 'lastUpdatePostDateStruct': {'date': '2015-06-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of gaz incontinence episodes', 'timeFrame': '3 days before randomization and treatement and 3 days after 10 days of treatment (antibiotic or conventionnal treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Anal Incontinence']}, 'descriptionModule': {'briefSummary': 'The objectives of this work are: 1/to estimate the frequency of a positive glucose breath test in favour of a small intestinal bacterial overgrowth in a population of patients consulting for gaz incontinence by comparison to a population of control subjects; 2/to estimate versus a conventional treatment the efficiency of an antibiotic treatment; in case of small intestinal bacterial overgrowth diagnosed by the glucose breath test, to improve gaz incontinence'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gaz incontinence for more than 3 months\n* Afflilied to national health security\n* Having read and sign the information letter and consent form\n\nExclusion Criteria:\n\n* Pregnancy\n* use of antibiotics, probiotics, IPP for less tha n 3 months\n* past of small intestinal bacterial overgrowth\n* ischemic, inflammatory colitis,colo-rectal cancer\n* diabetes\n* allergy to metronidazole\n* psychiatric disease\n* patients who do not speak or read french'}, 'identificationModule': {'nctId': 'NCT01275560', 'briefTitle': 'Does the Negativation of the Glucose Hydrogen Breath Test Come Along With a Reduction of the Symptoms of Gaz Incontinence ?', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Rouen'}, 'orgStudyIdInfo': {'id': '2008/073/HP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Metronidazole', 'description': '3 intakes per day during 10 days', 'interventionNames': ['Drug: Metronidazole']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Carbosylane', 'description': '3 intakes per daysduring 10 days', 'interventionNames': ['Drug: CArbosylane']}], 'interventions': [{'name': 'Metronidazole', 'type': 'DRUG', 'description': 'Metronidazole,per os,500mg, 3 per day during 10 days', 'armGroupLabels': ['Metronidazole']}, {'name': 'CArbosylane', 'type': 'DRUG', 'armGroupLabels': ['Carbosylane']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76031', 'city': 'Rouen', 'country': 'France', 'facility': 'Physiology Unit, Hopital Charles Nicolle, 1 rue de Germont', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Rouen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}