Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
Study NCT ID:
NCT00933556
Status:
COMPLETED
Last Update Posted:
2015-10-08
First Post:
2009-07-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Pilot Trial to Determine the Efficacy of VSL#3 for Reducing Colonization by VRE
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073893', 'term': 'Sugars'}, {'id': 'C026285', 'term': 'trichlorosucrose'}], 'ancestors': [{'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-06', 'studyFirstSubmitDate': '2009-07-02', 'studyFirstSubmitQcDate': '2009-07-06', 'lastUpdatePostDateStruct': {'date': '2015-10-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The main outcomes will be the proportion of patients colonized with VRE at 4 weeks, 8 weeks, 12 weeks and 24 weeks following start of treatment.', 'timeFrame': '24 weeks'}], 'secondaryOutcomes': [{'measure': 'Incidence of clinical infections will be assessed in the one year following enrollment into the study.', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['infection', 'probiotics'], 'conditions': ['Anti-biotic Resistance']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the feasibility, safety and efficacy of oral probiotic, VSL#3 versus oral placebo for reducing colonization by VRE.', 'detailedDescription': 'Healthcare-associated infections are an important threat to patient safety. Currently, between 5 and 10 percent of patients admitted to acute care hospitals acquire one or more infections; healthcare-associated infections affect approximately 2 million patients each year in the United States, result in 90,000 deaths, and are associated with an added cost of $4.5 to $5.7 billion per year. Seventy percent of healthcare-associated infections are caused by antimicrobial resistant bacteria, such as vancomycin-resistant enterococcus (VRE), resulting in increased antimicrobial usage, morbidity and mortality, making prevention of multiresistant bacteria essential.\n\nEradication of colonization has been shown to greatly reduce infection; however, there are no reliable means of providing sustained eradication of colonization. No effective means of eradicating VRE intestinal colonization exist.\n\nProbiotics containing strains of lactobacilli represent a novel approach to the prevention and control of antimicrobial resistance and have been studied extensively for a variety of infections. Even though various studies have shown probiotics to be effective for prevention of vaginal infections, urinary tract infections, etc no studies have examined the potential of probiotics to eradicate colonization by resistant pathogens, such as VRE.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subjects will be male or female\n* 18 years of age or older\n* may or may not be hospitalized\n* able to take oral medications\n* have been found to be colonized with VRE or at high risk of being colonized by VRE and are not taking antibiotics\n\nExclusion Criteria:\n\n* people on antibiotics will not be eligible to participate'}, 'identificationModule': {'nctId': 'NCT00933556', 'acronym': 'PROVE', 'briefTitle': 'A Pilot Trial to Determine the Efficacy of VSL#3 for Reducing Colonization by VRE', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'A Pilot Randomized Trial to Determine the Efficacy of a Probiotic, VSL#3 for Reducing Colonization by Vancomycin-resistant Enterococcus (VRE)', 'orgStudyIdInfo': {'id': 'H-2008-0023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'probiotic', 'description': 'subjects will be given a powder formulation of a probiotic VSL#3 to be taken once a day, at a dose of 6 gms', 'interventionNames': ['Dietary Supplement: VSL#3']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'sugar pill', 'description': 'placebo identical to the active product will be given', 'interventionNames': ['Dietary Supplement: sugar pill (placebo)']}], 'interventions': [{'name': 'VSL#3', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['yoplait', 'activia'], 'description': '6 gms of powder formulation to be given once a day for 4 weeks', 'armGroupLabels': ['probiotic']}, {'name': 'sugar pill (placebo)', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['splenda'], 'description': 'placebo identical to the active product will be given', 'armGroupLabels': ['sugar pill']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of wisconsin hospital', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Nasia Safdar, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin Department of Medicine (Infectious Disease)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}