Ignite Creation Date:
2025-12-24 @ 12:12 PM
Ignite Modification Date:
2026-01-01 @ 2:08 PM
Study NCT ID:
NCT00447161
Status:
COMPLETED
Last Update Posted:
2008-09-05
First Post:
2007-03-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preventing Antibiotic-Associated DiarRhea Using Erceflora
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003968', 'term': 'Diarrhea, Infantile'}], 'ancestors': [{'id': 'D003967', 'term': 'Diarrhea'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 323}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'lastUpdateSubmitDate': '2008-09-04', 'studyFirstSubmitDate': '2007-03-13', 'studyFirstSubmitQcDate': '2007-03-13', 'lastUpdatePostDateStruct': {'date': '2008-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in the incidence of antibiotic-associated diarrhea (relative risk)', 'timeFrame': 'From baseline to end of treatment'}, {'measure': 'All adverse event regardless of seriousness or relationship to the study drug', 'timeFrame': 'From baseline to end of treatment'}], 'secondaryOutcomes': [{'measure': 'Reduction in the number of antibiotic-associated diarrhea events per day', 'timeFrame': 'From baseline to end of treatment'}, {'measure': 'Reduction in the severity of diarrhea events', 'timeFrame': 'From baseline to end of treatment'}, {'measure': 'Reduction in Gastrointestinal-related symptoms (nausea, vomiting, abdominal pain)over-all reduction in the number of hospitalization days beween control and treatment groups.', 'timeFrame': 'From baseline to end of treatment'}, {'measure': 'Reduction in C. dificille -associated diarrhea.', 'timeFrame': 'From baseline to end of treatment'}]}, 'conditionsModule': {'conditions': ['Diarrhea, Infantile']}, 'descriptionModule': {'briefSummary': 'To determine the effectiveness of the pre-biotic Bacillus clausii in preventing antibiotic associated diarrhea among hospitalized immunocompetent Filipino children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinically stable children with mild to moderate illness admitted for treatment of bacterial infection.\n\nExclusion Criteria:\n\n* Children with unstable medical condition\n* In any form of immunocompromized state\n* With contraindication to take medication\n* Has taken antibiotics for 3 weeks before start of trial.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT00447161', 'acronym': 'PADRE', 'briefTitle': 'Preventing Antibiotic-Associated DiarRhea Using Erceflora', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Bacillus Clausii in Preventing Antibiotic-Associated Diarrhea Among Filipino Infant and Children: A Multi-Center, Randomized, Open-Label Controlled (Treatment vs No Treatment) Clinical Trial of Efficacy and Safety', 'orgStudyIdInfo': {'id': 'ENTER_L_01125'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Bacillus Clausii Multi ATB Resist', 'interventionNames': ['Drug: Bacillus Clausii Multi ATB Resist']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Bacillus Clausii Multi ATB Resist', 'type': 'DRUG', 'description': 'Twice daily dose of 1 vial of 1x10\\^9 of Bacillus clausii spores, orally suspension in water', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matched placebo', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Manila', 'country': 'Philippines', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}], 'overallOfficials': [{'name': 'Paz Figueroa', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Medical Affairs Study Director', 'oldOrganization': 'sanofi-aventis'}}}}