Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-03-11 @ 12:59 PM
Study NCT ID:
NCT00594594
Status:
TERMINATED
Last Update Posted:
2009-07-07
First Post:
2008-01-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adjuntive Probiotic Therapy in Treating Urinary Tract Infections in Spinal Cord Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D014552', 'term': 'Urinary Tract Infections'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Unable to recruit enough patients to continue on with the study.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-07-06', 'studyFirstSubmitDate': '2008-01-04', 'studyFirstSubmitQcDate': '2008-01-14', 'lastUpdatePostDateStruct': {'date': '2009-07-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Increase time to next UTI', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Numbers of infections of any type occurring during probiotic treatment', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['spinal cord injury', 'urinary tract infection', 'probiotics', 'Lactobacilli'], 'conditions': ['Spinal Cord Injury', 'Urinary Tract Infections']}, 'referencesModule': {'references': [{'pmid': '17324320', 'type': 'BACKGROUND', 'citation': 'Hayes KC, Bassett-Spiers K, Das R, Ethans KD, Kagan C, Kramer JL, Linsenmeyer T, Moore KN, Razvi H, Reid G, Walter JS, Wilson JW. Research priorities for urological care following spinal cord injury: recommendations of an expert panel. Can J Urol. 2007 Feb;14(1):3416-23.'}]}, 'descriptionModule': {'briefSummary': 'We hypothesize that probiotic Lactobacillus can augment antibiotic treatment of symptomatic urinary tract infection (UTI) in spinal cord injured patients, and also increase the time to the next episode of UTI.', 'detailedDescription': "Subjects will be recruited from the outpatient population and 'alumni' of the Regional SCI Rehabilitation Programs in London (Parkwood Hospital/St Joseph's Health Care) and Hamilton (Hamilton Health Sciences Centre) Ontario.\n\nCommunity living paraplegic and tetraplegic men and women (18 years and above) who present to their family physician or specialist with symptomatic UTI will be prescribed an antibiotic treatment for up to 14 days (using the drug of choice i.e. which the treating physician deems appropriate) and randomized to also receive by mouth two capsules containing placebo or probiotic Lactobacillus rhamnosus GR-1 and L. reuteri RC-14 daily."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Spinal cord injury\n* UTI\n* \\> 18years\n* Male and females\n* Prescribed antibiotics\n\nExclusion Criteria:\n\n* Patients who are participating in another clinical study involving pharmaceutical products.\n* Patients who are participating in other urology clinical study.\n* Patients taking yogurt containing probiotic lactobacilli during the period of the study.\n* Females who are pregnant and/or planning to get pregnant during the study period'}, 'identificationModule': {'nctId': 'NCT00594594', 'briefTitle': 'Adjuntive Probiotic Therapy in Treating Urinary Tract Infections in Spinal Cord Injury', 'organization': {'class': 'OTHER', 'fullName': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}, 'officialTitle': 'A Multi-Centered, Randomized, Double-Blind, Placebo-Controlled Trial for Efficacy in the Use of Adjuntive Probiotic Therapy in Reducing Urinary Tract Infections in Those Individual With Spinal Cord Injury', 'orgStudyIdInfo': {'id': 'R-06-213'}, 'secondaryIdInfos': [{'id': 'HSREB 12845'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Probiotic Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14', 'interventionNames': ['Other: Probiotic Lactobacillus GR-1 and RC-14']}], 'interventions': [{'name': 'Probiotic Lactobacillus GR-1 and RC-14', 'type': 'OTHER', 'description': 'Two capsules of Lactobacillus GR-1 and RC-14 daily for 12 months', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6A 4V2', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Joseph's Health Care", 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'overallOfficials': [{'name': 'Patrick J Potter, MD FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Joseph's Health Care Centre, Parkwood Hospital, Lawson Health Research Institute"}, {'name': 'Gregor Reid, PhD, MBA', 'role': 'STUDY_DIRECTOR', 'affiliation': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}, {'name': 'Keith Hayes, PhD', 'role': 'STUDY_CHAIR', 'affiliation': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}, {'name': 'Kingsley C Anukam, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lawson Health Research Institute, kanukam@uwo.ca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's", 'class': 'OTHER'}, 'collaborators': [{'name': 'Ontario Neurotrauma Foundation', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Dr. Gregor Reid', 'oldOrganization': 'Lawson Health Research Institute'}}}}