Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
Study NCT ID:
NCT00596635
Status:
COMPLETED
Last Update Posted:
2013-03-29
First Post:
2008-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cranberry for UTI Prevention in Residents of Long Term Care Facilities
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014552', 'term': 'Urinary Tract Infections'}, {'id': 'D004927', 'term': 'Escherichia coli Infections'}], 'ancestors': [{'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'}, {'id': 'D004756', 'term': 'Enterobacteriaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'manisha.juthanimehta@yale.edu', 'phone': '(203)785-4140', 'title': 'Manisha Juthani-Mehta, MD', 'organization': 'Yale University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The inability to follow all participants for the full six months reflects the vulnerability of the population.'}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'No Cranberry Capsules', 'description': 'Control Group No Cranberry Capsule', 'otherNumAtRisk': 17, 'otherNumAffected': 3, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'One Cranberry Capsule', 'description': '1 650mg cranberry capsule daily', 'otherNumAtRisk': 20, 'otherNumAffected': 5, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '2 Cranberry Capsules', 'description': '1 650 mg cranberry capsule twice daily (bid)', 'otherNumAtRisk': 19, 'otherNumAffected': 3, 'seriousNumAtRisk': 19, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Number of Participants With E.Coli Isolated From Urine Culture', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'No Cranberry Capsules', 'description': 'Control Group No Cranberry Capsule'}, {'id': 'OG001', 'title': 'One Cranberry Capsule', 'description': '1 650mg cranberry capsule daily'}, {'id': 'OG002', 'title': '2 Cranberry Capsules', 'description': '1 650 mg cranberry capsule twice daily (bid)'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Urine cultures were obtained at baseline and monthly for six months. Any participant that had E.coli isolated at least once is listed as meeting the outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With >100,000 Colony Forming Units Per Milliliter of Any Organism Isolated From Urine Culture', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'No Cranberry Capsules', 'description': 'Control Group No Cranberry Capsule'}, {'id': 'OG001', 'title': 'One Cranberry Capsule', 'description': '1 650mg cranberry capsule daily'}, {'id': 'OG002', 'title': '2 Cranberry Capsules', 'description': '1 650 mg cranberry capsule twice daily (bid)'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Urine cultures were obtained at baseline and monthly for 6 months. If a urine culture had \\>100,000 colony forming units per milliliter of any organism on any of the urine cultures obtained, the participant is noted as meeting the outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Urine Cultures Collected Out of the Total Number Expected to be Collected.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'No Cranberry Capsules', 'description': 'Control Group No Cranberry Capsule'}, {'id': 'OG001', 'title': 'One Cranberry Capsule', 'description': '1 650mg cranberry capsule daily'}, {'id': 'OG002', 'title': '2 Cranberry Capsules', 'description': '1 650 mg cranberry capsule twice daily (bid)'}], 'classes': [{'title': 'Number of urine cultures expected', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}]}, {'title': 'Number of urine cultures collected', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Urine cultures were collected at baseline and monthly for six months. The total number of urine cultures collected out of the total number that were expected to be collected are shown.', 'unitOfMeasure': 'Urine cultures', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'No Cranberry Capsules', 'description': 'Control Group No Cranberry Capsule'}, {'id': 'FG001', 'title': 'One Cranberry Capsule', 'description': '1 650mg cranberry capsule daily'}, {'id': 'FG002', 'title': '2 Cranberry Capsules', 'description': '1 650 mg cranberry capsule twice daily (bid)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Treatment for symptomatic UTI', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Hip fracture', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Could not provide urine specimen', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Four dementia units participated in this study. Exclusion criteria included: 1)indwelling catheter, 2)residence \\<4 weeks, 3)prednisone therapy, 4)active UTI symptoms, 5)terminal, 6)end stage renal disease, 7)\\<60 years old, 8)chronic suppressive antibiotic therapy, 9)history of kidney stones, 10)unable to provide baseline urine, 11)warfarin therapy.', 'preAssignmentDetails': 'If a participant could not provide a baseline urine specimen or met an exclusion criterion prior to group assignment but after consent, he or she was not enrolled.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'No Cranberry Capsules', 'description': 'Control Group No Cranberry Capsule'}, {'id': 'BG001', 'title': 'One Cranberry Capsule', 'description': '1 650mg cranberry capsule daily'}, {'id': 'BG002', 'title': '2 Cranberry Capsules', 'description': '1 650 mg cranberry capsule twice daily (bid)'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '85.76', 'spread': '11.76', 'groupId': 'BG000'}, {'value': '88.30', 'spread': '6.16', 'groupId': 'BG001'}, {'value': '86.68', 'spread': '5.16', 'groupId': 'BG002'}, {'value': '86.82', 'spread': '7.97', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-19', 'studyFirstSubmitDate': '2008-01-08', 'resultsFirstSubmitDate': '2010-06-30', 'studyFirstSubmitQcDate': '2008-01-08', 'lastUpdatePostDateStruct': {'date': '2013-03-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-09-01', 'studyFirstPostDateStruct': {'date': '2008-01-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Urine Cultures Collected Out of the Total Number Expected to be Collected.', 'timeFrame': '6 months', 'description': 'Urine cultures were collected at baseline and monthly for six months. The total number of urine cultures collected out of the total number that were expected to be collected are shown.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With E.Coli Isolated From Urine Culture', 'timeFrame': '6 months', 'description': 'Urine cultures were obtained at baseline and monthly for six months. Any participant that had E.coli isolated at least once is listed as meeting the outcome.'}, {'measure': 'Number of Participants With >100,000 Colony Forming Units Per Milliliter of Any Organism Isolated From Urine Culture', 'timeFrame': '6 months', 'description': 'Urine cultures were obtained at baseline and monthly for 6 months. If a urine culture had \\>100,000 colony forming units per milliliter of any organism on any of the urine cultures obtained, the participant is noted as meeting the outcome.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['UTI', 'elderly', 'prevention', 'cranberry', 'E.Coli'], 'conditions': ['Urinary Tract Infection']}, 'referencesModule': {'references': [{'pmid': '20929476', 'type': 'RESULT', 'citation': 'Juthani-Mehta M, Perley L, Chen S, Dziura J, Gupta K. Feasibility of cranberry capsule administration and clean-catch urine collection in long-term care residents. J Am Geriatr Soc. 2010 Oct;58(10):2028-30. doi: 10.1111/j.1532-5415.2010.03080.x. No abstract available.'}, {'pmid': '37947276', 'type': 'DERIVED', 'citation': 'Williams G, Stothart CI, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Nov 10;11(11):CD001321. doi: 10.1002/14651858.CD001321.pub7.'}, {'pmid': '37068952', 'type': 'DERIVED', 'citation': 'Williams G, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Apr 17;4(4):CD001321. doi: 10.1002/14651858.CD001321.pub6.'}]}, 'descriptionModule': {'briefSummary': 'Urinary tract infections (UTIs) affect over 7 million men and women per year and cost the health care industry over 1 billion dollars annually. The incidence of UTI increases markedly in elderly institutionalized persons and leads to excessive antimicrobial usage, emergency room visits, hospitalization, sepsis, and death. The use of antimicrobials to prevent UTI in elderly nursing home patients is not recommended and is fraught with problems such as adverse reactions, drug interactions, and the development of drug-resistant organisms. There is no accepted method of preventing UTI in residents of nursing homes, a vulnerable and understudied population with significant morbidity from UTI.\n\nThe overall goal of this proposal is to conduct a prospective cohort pilot study that evaluates the feasibility of using cranberry to prevent UTI in nursing home residents. Each of the aims is critical for the optimal design of a larger placebo-controlled, definitive trial of cranberry for prevention of UTI in nursing home residents and will provide the essential preliminary data for future larger studies.', 'detailedDescription': 'Cranberry products represent a novel, non-antimicrobial method for prevention of UTI. There is evidence for a plausible mechanism and efficacy for UTI prevention in healthy premenopausal women. Limited clinical studies of cranberry products in elderly men and women have demonstrated reductions in bacteriuria but have not been of adequate size or quality to support the use of cranberry in this population or result in changes in patient care. Thus, a properly designed, definitive study demonstrating efficacy of cranberry in preventing UTI in this population is needed. However, before a large-scale, placebo-controlled trial can be justified, the complexities inherent to studying older nursing home residents need to be addressed. These include issues related to collecting uncontaminated urine samples, understanding the microbiology of UTI in this population, and devising an acceptable intervention regimen. The overall goal of this proposal is to conduct a prospective cohort pilot study that evaluates the feasibility of using cranberry to prevent UTI in nursing home residents. Each of the aims listed below is critical for the optimal design of a larger placebo-controlled, definitive trial of cranberry for prevention of UTI in nursing home residents and will provide the essential preliminary data for a future RO1 level grant application.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Greater than 60 years old and a resident of the nursing home or assisted living facility for greater than 30 days duration\n\nExclusion Criteria:\n\n* Having a known major anatomic abnormality of the urinary tract\n* Presence of acute UTI symptom\n* Intolerance or allergy to cranberry products\n* Current use of cranberry for prevention of UTI\n* Use of warfarin\n* History of kidney stones\n* Presence of a chronic indwelling bladder catheter\n* Dialysis dependence\n* Chronic suppressive antibiotics\n* Immunocompromised state due to hematological malignancies, HIV infection, chronic high dose (\\>10mg daily) prednisone or equivalent steroid use.'}, 'identificationModule': {'nctId': 'NCT00596635', 'acronym': 'PACS', 'briefTitle': 'Cranberry for UTI Prevention in Residents of Long Term Care Facilities', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Cranberry for UTI Prevention in Residents of Long Term Care Facilities', 'orgStudyIdInfo': {'id': '0606001581'}, 'secondaryIdInfos': [{'id': 'DF06-005'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'No cranberry capsules administered'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'One cranberry capsule', 'description': '1 650mg cranberry capsule daily', 'interventionNames': ['Dietary Supplement: Once Daily Cranberry Capsule']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Two cranberry capsules', 'description': '1 650 mg cranberry capsule twice daily (bid)', 'interventionNames': ['Dietary Supplement: Twice Daily Cranberry Capsules']}], 'interventions': [{'name': 'Once Daily Cranberry Capsule', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Theralogix: Theracran cranberry supplement, 650mg capsule'], 'description': '650mg capsule pure cranberry powder', 'armGroupLabels': ['One cranberry capsule']}, {'name': 'Twice Daily Cranberry Capsules', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Theralogix: Theracran cranberry supplement, 650mg capsule'], 'description': 'One 650mg cranberry capsule administered twice per day', 'armGroupLabels': ['Two cranberry capsules']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University School of Medicine, Internal Medicine, Section of Infectious Diseases', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Manisha Juthani-Mehta, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University School of Medicine, Assistant Professor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}