Cranberry Juice for Treatment of Urinary Tract Infections
Primary Purpose
Urinary Tract Infections
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cranberry juice
Placebo cranberry juice
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Tract Infections focused on measuring Vaccinium macrocarpon
Eligibility Criteria
Inclusion Criteria: Culture-confirmed urinary tract infection at study start Exclusion Criteria: Other chronic disease Antibiotics within 48 hours prior to study start Hospitalization for any reason within 2 weeks prior to study start Stones in urinary tract Plans to leave Ann Arbor within 6 months after study start Allergy to cranberry or cranberry compounds Pregnancy
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
Cranberry juice
Placebo juice
Outcomes
Primary Outcome Measures
Culture
Secondary Outcome Measures
Full Information
NCT ID
NCT00093054
First Posted
September 30, 2004
Last Updated
April 14, 2015
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT00093054
Brief Title
Cranberry Juice for Treatment of Urinary Tract Infections
Official Title
Cranberry Juice and Urinary Tract Infections
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether daily consumption of cranberry juice lessens the symptoms and prevents the recurrence of urinary tract infections (UTIs). This study will also determine whether drinking cranberry juice for 6 months selects for less virulent bacteria in the rectal, vaginal, and urethral areas.
Detailed Description
Participants in this study will be randomly assigned to consume either 8 ounces of cranberry juice or placebo juice twice a day for 6 months. Participants will have follow-up visits at 3 and 6 months, and whenever they experience a symptomatic episode. Urine, vaginal and rectal specimens will be taken at each visit to test for the presence of bacteria that cause urinary tract infections. Participants will complete a questionnaire at study entry, Day 3, Weeks 1 and 2, and monthly thereafter or whenever there is a recurrence of symptoms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections
Keywords
Vaccinium macrocarpon
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
319 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Cranberry juice
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo juice
Intervention Type
Drug
Intervention Name(s)
Cranberry juice
Intervention Description
TID dosage for UTI treatment
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo cranberry juice
Intervention Description
TID placebo dosage to match active comparator
Primary Outcome Measure Information:
Title
Culture
Time Frame
per visit
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Culture-confirmed urinary tract infection at study start
Exclusion Criteria:
Other chronic disease
Antibiotics within 48 hours prior to study start
Hospitalization for any reason within 2 weeks prior to study start
Stones in urinary tract
Plans to leave Ann Arbor within 6 months after study start
Allergy to cranberry or cranberry compounds
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cibele T. Barbosa-Cesnik
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Cranberry Juice for Treatment of Urinary Tract Infections
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