Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-25 @ 4:23 PM
Study NCT ID:
NCT00700557
Status:
COMPLETED
Last Update Posted:
2009-08-25
First Post:
2008-05-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Probiotics at the Treatment of Antibiotic Associated Diarrhea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013213', 'term': 'Starch'}], 'ancestors': [{'id': 'D005936', 'term': 'Glucans'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011134', 'term': 'Polysaccharides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-08-24', 'studyFirstSubmitDate': '2008-05-15', 'studyFirstSubmitQcDate': '2008-06-17', 'lastUpdatePostDateStruct': {'date': '2009-08-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of discharge numbers, change the consistency of the feces and occurence of relapses.', 'timeFrame': 'After 24 hours of the intervention started'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Antibiotic Associated Diarrhea', 'probiotics', 'treatment'], 'conditions': ['Antibiotic-Associated Diarrhea']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to know the efficacy of the treatment with probiotics, Lactobacillus casei and Bifidobacterium breve, on clinical evidences and occurence of relapses on antibiotic-associated diarrhea.', 'detailedDescription': 'The Antibiotic-Associated Diarrhea (AAD)is defined as that developed after the started antibiotic therapy ou until six to eight weeks after the end of the treatment. The occurence of AAD is about 5% to 25% of the patients using antibiotics and cause watery diarrhea, fever and vomit, mainly on pseudomembranous colitis. Several studies had demonstrated the use of probiotics as therapeutic or preventive form of AAD with or without the presence of C. difficile. About the tolerance of the probiotics,there weren´t observed deleterious effects on health with the consumption of 106 - 107 UFC of Lactobacillus spp and Bifidobacterium spp during a period of one year. The realization of this study can demonstrate the efficacy of Lactobacillus casei e Bifidobacterium breve at the treatment of AAD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hospitalized patients with diarrhea using antibiotic during, at least, 24 hours or had used antibiotic 07 days prior to study entry.\n\nExclusion Criteria:\n\n* Patients with chronic diarrhea, viral diarrhea, critical patients, during or after radio or chemiotherapy treatment,\n* HIV infections,\n* Ulcerative colitis,\n* Crohn´s disease,\n* Hydroelectrolytic disturbance,\n* Small intestine syndrome,\n* Colostomized, jejunostomized\n* Lactose intolerance,\n* Rapid enteral diet infusion (\\>120mh/h),\n* Hyperosmolar enteral diet.'}, 'identificationModule': {'nctId': 'NCT00700557', 'briefTitle': 'Probiotics at the Treatment of Antibiotic Associated Diarrhea', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Uberlandia'}, 'officialTitle': 'Lactobacillus Casei e Bifidobacterium Breve as Probiotics at the Treatment of Antibiotic Associated Diarrhea: a Randomized Double Blind Study', 'orgStudyIdInfo': {'id': 'changeme-12332111'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Probiotics - Lactobacillus casei and Bifidobacterium breve', 'description': 'Yakult LB®\n\n1 sachet (1g) of Lactobacillus casei and Bifidobacterium breve - 6 x 108 UFC/g on a juice three times a day', 'interventionNames': ['Dietary Supplement: Probiotics - Lactobacillus casei and Bifidobacterium breve']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'maize starch', 'description': '725mg on juice three times a day', 'interventionNames': ['Dietary Supplement: Maize starch']}], 'interventions': [{'name': 'Probiotics - Lactobacillus casei and Bifidobacterium breve', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Experimental group:This group received enteral tube feeding or oral diet plus a juice containing 1 sachet (1g) of probiotics (Lactobacillus casei and Bifidobacterium breve - 6x 108 UFC/g) three times a day.', 'armGroupLabels': ['Probiotics - Lactobacillus casei and Bifidobacterium breve']}, {'name': 'Maize starch', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo group: This groups received enteral tube feeding or oral diet plus a juice containing,approximately, 725mg of placebo three times a day.', 'armGroupLabels': ['maize starch']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38400-902', 'city': 'Uberlândia', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'Federal University of Uberlândia', 'geoPoint': {'lat': -18.91861, 'lon': -48.27722}}], 'overallOfficials': [{'name': 'Miguel T Jorge, Medicine', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of Uberlandia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of Uberlandia', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Faculdade de Medicina (FAMED)', 'oldOrganization': 'Agnaldo Coelho da Silva'}}}}