Ignite Creation Date:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2025-12-27 @ 9:41 PM
Study NCT ID:
NCT01219595
Status:
COMPLETED
Last Update Posted:
2016-01-29
First Post:
2010-10-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cranberry Proanthocyanidins for Modification of Intestinal E. Coli Flora and Prevention of Urinary Tract Infections in UTI-Susceptible Women
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-28', 'studyFirstSubmitDate': '2010-10-08', 'studyFirstSubmitQcDate': '2010-10-08', 'lastUpdatePostDateStruct': {'date': '2016-01-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pre-treatment heterogeneity or prevalence', 'timeFrame': 'Day 1 - prior to start of study treatment', 'description': '1\\) Prevalence or heterogeneity of E. coli strains in UTI susceptible women pre-treatment'}, {'measure': 'Post-treatment heterogeneity', 'timeFrame': '2 weeks, 1 month, or 3 months', 'description': '2\\) a change in the heterogeneity of strains post treatment'}, {'measure': 'Patient acceptance of study regimen', 'timeFrame': '2 weeks, 1 month, or 3 months', 'description': '3\\) patient acceptance of the study regimen'}, {'measure': 'Maintenance of heterogeneity in the intestinal flora', 'timeFrame': 'Approximately 3 months', 'description': 'To determine whether a shift towards strain heterogeneity in the intestinal flora can be maintained over a three month period.'}, {'measure': 'Measure Effects of sweetened, dried cranberries on E. coli clonotypes over three two-week exposures', 'timeFrame': 'Approximately 3 months', 'description': 'Measure effects of sweetened, dried cranberries on E. coli clonotypes over three two-week exposures'}, {'measure': 'Measure effects of sweetened, dried cranberries on E. coli clonotypes over one 4-week exposure', 'timeFrame': '2 weeks, 1 month, or 3 months', 'description': 'Measure effects of sweetened, dried cranberries on E. coli clonotypes over one 4-week exposure'}, {'measure': 'Measure the UTI recurrence', 'timeFrame': '2 weeks, 1 month, or 3 months', 'description': 'Measure the UTI recurrence after 6 months from the beginning of the study.'}, {'measure': 'Comparison of sweetened dried cranberries to a placebo group', 'timeFrame': '2 weeks, 1 month, or 3 months', 'description': 'Comparison of sweetened dried cranberries to a placebo group (strawberry fruit pieces)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Urinary Tract Infection', 'UTI'], 'conditions': ['Urinary Tract Infection']}, 'descriptionModule': {'briefSummary': 'The purpose of the research is to determine if eating sweetened, dried cranberries or strawberry fruit pieces will increase the types of different E. coli bacteria in the intestines which may reduce the likelihood of a major, or highly harmful urinary type of bacteria which cause urinary tract infections in susceptible women.', 'detailedDescription': 'This is a research study about the number and types of bacteria that cause urinary tract infections (E. coli strains) that are present in the intestine. The bacteria will be collected and analyzed before and after eating either sweetened, dried cranberries or strawberry fruit pieces. This study will help us learn more about whether or not the components of consumed sweetened, dried cranberries or strawberry fruit pieces reduce the numbers of harmful E. coli bacteria in the vaginal and intestinal tracts, thereby reducing the number of urinary tract infections among women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Women, ages 18-65\n* History of recurrent urinary tract infections defined as three in the past year, or two in the last six months\n* Subjects must be willing to follow the study protocol that includes consuming the mandatory daily dose of cranberries or strawberry fruit pieces and traveling to the UWHC Urology clinic for scheduled rectal and vaginal swab procedures.\n\nThe non-UTI-susceptible group will include women ages 18-65 with no history of recurrent UTI's as defined above.\n\nExclusion Criteria:\n\nWomen who:\n\n* Are pregnant\n* Have an immune compromising disease\n* Have diabetes\n* Have kidney stones\n* Have chronic bowel inflammatory disease\n* Have known allergies to cranberries, strawberries, elderberries, or wheat fiber\n\nNon-UTI-susceptible group will include women ages 18-65 with no history of recurrent UTI's as defined above."}, 'identificationModule': {'nctId': 'NCT01219595', 'briefTitle': 'Cranberry Proanthocyanidins for Modification of Intestinal E. Coli Flora and Prevention of Urinary Tract Infections in UTI-Susceptible Women', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Cranberry Proanthocyanidins for Modification of Intestinal E. Coli Flora and Prevention of Urinary Tract Infections in UTI-Susceptible Women', 'orgStudyIdInfo': {'id': 'H-2010-0107'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Part 1', 'description': '1 serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for two weeks.', 'interventionNames': ['Other: Sweetened, dried cranberries']}, {'type': 'OTHER', 'label': 'No treatment', 'description': '20 non-UTI susceptible women will be enrolled to collect data on the types of E. coli flora present in non-UTI women.', 'interventionNames': ['Other: Observation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Part 2A', 'description': '1 serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for three separate, two-week periods. Each two week period will be separated by a two-week interval.', 'interventionNames': ['Other: Sweetened, dried cranberries']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part 2B', 'description': '1 serving (1/3 cup; 42 g) of strawberry fruit pieces each day for three separate, two-week periods. Each two week period will be separated by a two-week interval.', 'interventionNames': ['Other: Strawberry Fruit Pieces']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Part 3A', 'description': '1 serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for one 4-week period.', 'interventionNames': ['Other: Sweetened, dried cranberries']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part 3B', 'description': '1 serving (1/3 cup; 42 g) of strawberry fruit pieces each day for one 4-week period.', 'interventionNames': ['Other: Strawberry Fruit Pieces']}], 'interventions': [{'name': 'Sweetened, dried cranberries', 'type': 'OTHER', 'description': 'Women in Arm 1 will consume one serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for two weeks.', 'armGroupLabels': ['Part 1', 'Part 2A', 'Part 3A']}, {'name': 'Strawberry Fruit Pieces', 'type': 'OTHER', 'description': '1 serving (1/3 cup; 42 g) of strawberry fruit pieces each day for three separate, two-week periods. Each two week period will be separated by a two-week interval.', 'armGroupLabels': ['Part 2B', 'Part 3B']}, {'name': 'Sweetened, dried cranberries', 'type': 'OTHER', 'description': '1 serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for three separate, two-week periods. Each two week period will be separated by a two-week interval.', 'armGroupLabels': ['Part 1', 'Part 2A', 'Part 3A']}, {'name': 'Sweetened, dried cranberries', 'type': 'OTHER', 'description': '1 serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for one 4-week period.', 'armGroupLabels': ['Part 1', 'Part 2A', 'Part 3A']}, {'name': 'Strawberry Fruit Pieces', 'type': 'OTHER', 'description': '1 serving (1/3 cup; 42 g) of strawberry fruit pieces each day for one 4-week period.', 'armGroupLabels': ['Part 2B', 'Part 3B']}, {'name': 'Observation', 'type': 'OTHER', 'description': 'Subjects in the non-UTI susceptible group will have one visit where one vaginal and one rectal swab will be collected.', 'armGroupLabels': ['No treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin-Madison', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Walter Hopkins, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ocean Spray Cranberries, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}