Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-25 @ 8:17 PM
Study NCT ID:
NCT00265369
Status:
COMPLETED
Last Update Posted:
2011-01-11
First Post:
2005-11-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
TEDDY: Spores of Bacillus Clausii in Acute Diarrhoea in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003967', 'term': 'Diarrhea'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 420}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'lastUpdateSubmitDate': '2011-01-10', 'studyFirstSubmitDate': '2005-11-04', 'studyFirstSubmitQcDate': '2005-12-13', 'lastUpdatePostDateStruct': {'date': '2011-01-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of diarrhoea as counted from the first intake of the investigational product up to the first appearance of a loose stool followed by two-consecutive normal stools'}], 'secondaryOutcomes': [{'measure': "Number of infants/children with normal stools at D3, D4, D5, D6 and D7;Mean number of stools per day;Occurrence of vomiting episodes per day after enrolment;Parents'overall global assessment of efficacy at the end of the treatment;other safety criteria"}]}, 'conditionsModule': {'conditions': ['Diarrhea']}, 'descriptionModule': {'briefSummary': 'Primary objective:\n\n* To demonstrate the efficacy of a Bacillus clausii probiotic strain compared to placebo in children suffering from acute diarrhoea and treated for 7 days.\n\nSecondary objective:\n\n* To evaluate the clinical safety of the Bacillus clausii probiotic strain versus placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '36 Months', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\nInfants or Children\n\n* Non hospitalized infants or children\n* With acute diarrhea evident for less than 48 hours\n* Having had three or more watery stools during the preceding 24 hours\n\nExclusion criteria:\n\nInfants or Children\n\n* With blood stools\n* Having been treated with antibiotics or probiotics within the two weeks before the enrollment\n* Suffering from dehydration defined by a weight loss of at least 5% or by the presence of a skin fold\n* With an history of seizures\n* With immunosuppressive conditions\n* With a current status requiring an antibiotic treatment\n* Suffering from a chronic disease including chronic diarrhea whatever the origin\n* Having received before inclusion one of the following treatments:\n\n * Probiotics\n * Prebiotics\n * Drugs with adsorbing properties\n * Drugs that modify intestinal secretion like bismuth subsalicylate, acetorphan\n * Drugs that modify intestinal motility (opiates such as loperamide, atropine and other cholinergic agents).\n* Having participated in another clinical trial in the last 3 months prior to the start of the study'}, 'identificationModule': {'nctId': 'NCT00265369', 'briefTitle': 'TEDDY: Spores of Bacillus Clausii in Acute Diarrhoea in Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Comparative Efficacy and Safety of a Bacillus Clausii Probiotic Strain Versus Placebo in the Treatment of Acute Diarrhoea in Children', 'orgStudyIdInfo': {'id': 'C_9240'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Spores of Bacillus Clausii Probiotic Strain', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brussels', 'country': 'Belgium', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Paris', 'country': 'France', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Gilles Perdriset, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}}}}