Ignite Creation Date:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2025-12-26 @ 7:57 AM
Study NCT ID:
NCT00100061
Status:
UNKNOWN
Last Update Posted:
2013-03-12
First Post:
2004-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Cranberry-Containing Products in Women With Recurrent Urinary Tract Infections (UTIs)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014552', 'term': 'Urinary Tract 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2013-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-03-11', 'studyFirstSubmitDate': '2004-12-22', 'studyFirstSubmitQcDate': '2004-12-22', 'lastUpdatePostDateStruct': {'date': '2013-03-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Minimum dose of cranberry-containing product necessary to achieve a 30% prophylaxis of UTIs in women with recurrent UTIs', 'timeFrame': 'end of study', 'description': 'recurrence of UTI'}, {'measure': 'Whether the degree of UTI prophylaxis is related to the dose of cranberry-containing product (dose response curve)', 'timeFrame': 'end of study', 'description': 'comparison of UTI occurrence'}, {'measure': 'Whether proanthocyanidin concentration in the urine correlates with UTI prophylaxis', 'timeFrame': 'end of study', 'description': 'recurrence of UTI and lab results'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cranberry', 'Vaccinium macrocarpon'], 'conditions': ['Urinary Tract Infection']}, 'referencesModule': {'references': [{'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': 'The purpose of this study is to determine the role of cranberry-containing products in preventing urinary tract infections (UTIs).', 'detailedDescription': 'Although cranberry-containing products are commonly taken to prevent UTIs and other urinary symptoms, an optimally effective dose has not been established, and the chemicals responsible for the UTI-preventing properties in cranberry-containing products have yet to be determined. This study will determine the minimum dose of cranberry-containing product necessary to prevent UTIs, the effectiveness of cranberry-containing products in fighting different strains of E. coli, and the long-term effects of cranberry-containing product consumption. This study will also determine whether plant pigments called proanthocyanidins influence the UTI-preventing properties of cranberry-containing products.\n\nThis study will last 2 years. Participants will be randomly assigned to receive varying doses of either cranberry-containing products or placebo for 1 year. Some participants will receive cranberry or placebo supplement tablets; others will receive cranberry juice or a placebo beverage. Clinic visits will occur every 2 months; urine collection will occur at each visit. Some participants will be asked to collect 24-hour urine samples every 8 weeks and provide urine samples on Days 1, 3, 5 and 7.\n\nLaboratory tests will be used to assess participants during the study. A 3-day course of antibiotics will be provided to participants developing a UTI during the course of the study. Telephone interview follow-up at 6 and 12 months after the study will determine whether cranberry-containing product use has continued and whether UTIs have recurred.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least two UTIs in the year prior to study entry\n* Willing to use acceptable methods of contraception\n* Willing to refrain from consuming other forms of cranberry supplementation\n\nExclusion Criteria:\n\n* Current UTI\n* Allergy to cranberry-containing products\n* Active urinary stone disease\n* Insulin-dependent diabetes\n* Immunosuppressive disease\n* Current corticosteroid use\n* Intermittent or indwelling catheterization\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT00100061', 'briefTitle': 'Effects of Cranberry-Containing Products in Women With Recurrent Urinary Tract Infections (UTIs)', 'organization': {'class': 'NIH', 'fullName': 'National Center for Complementary and Integrative Health (NCCIH)'}, 'officialTitle': 'Dose Response to Cranberry of Women With Recurrent UTIs', 'orgStudyIdInfo': {'id': 'R01AT002090-01', 'link': 'https://reporter.nih.gov/quickSearch/R01AT002090-01', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cranberry Juice', 'description': 'Cranberry Juice provided by Ocean Spray', 'interventionNames': ['Drug: Cranberry juice', 'Dietary Supplement: Cranberry Juice']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo cranberry juice', 'description': 'Taken orally', 'interventionNames': ['Dietary Supplement: Placebo cranberry juice']}], 'interventions': [{'name': 'Cranberry juice', 'type': 'DRUG', 'description': 'liquid juice taken daily', 'armGroupLabels': ['Cranberry Juice']}, {'name': 'Cranberry Juice', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Taken orally', 'armGroupLabels': ['Cranberry Juice']}, {'name': 'Placebo cranberry juice', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo comparitor', 'armGroupLabels': ['Placebo cranberry juice']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V6T 2B5', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Bladder Care Centre, University of British Columbia', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Lynn Stothers, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bladder Care Centre, University of British Columbia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}, 'collaborators': [{'name': 'Office of Dietary Supplements (ODS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}