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Clinical Trial: Cranberry Juice for the Prevention of Recurrent Urinary Tract Infections
This study is currently recruiting patients.
Verified by National Center for Complementary and Alternative Medicine (NCCAM) August 2005
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Urinary Tract Infections | Drug: Cranberry juice cocktail | Phase II |
MedlinePlus related topics: Urinary Tract Infections
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Cranberry and Prevention of UTI A Comprehensive Approach
Secondary Outcomes: Colonization of vaginal and rectal flora; vaginal and rectal colonization with E. coli
Expected Total Enrollment: 350
Study start: August 2005
UTIs are a common problem among young women, resulting in considerable morbidity and health care costs. Increasing resistance to antibiotics is making treatment of these infections even more problematic. Therefore, safe and effective nonantimicrobial prevention strategies are needed. One approach that appears to be effective is the use of cranberry products. However, data on the safety and effectiveness of cranberry products are limited. This study will determine whether cranberry juice can reduce UTIs in women.
Participants will be randomly assigned to receive either cranberry juice or a placebo drink daily for 6 months. Study visits will occur every month for the 6-month treatment phase of the study. At study entry and at each study visit, urine collection will occur and vaginal swabs will be taken. A rectal swab will be taken at study entry and at the Month 2 and 4 visits. Participants will be asked about medication usage, any side effects they may be experiencing, and diet at each study visit. If participants develop a UTI at any time during the study, they will be asked to visit the study site within 24 hours.
Eligibility
Inclusion Criteria:
- At least one UTI within 12 months prior to study entry
- Premenopausal
- Agree to avoid all foods that contain plants from the genus Vaccinium (related to cranberries) for the duration of the study
Exclusion Criteria:
- Anatomic abnormalities of the urinary tract
- History of kidney stones
- Bacteria in the urine (bacteriuria)
- Use of prophylactic antibiotics within 7 days prior to study entry
- Use of investigational drugs within 30 days prior to study entry
- Current use of warfarin
- Diabetes
- Cancer. Participants with skin cancer are not excluded.
- Allergy or intolerance of cranberry products
- Symptomatic vaginitis
- Pregnant or breastfeeding
Location and Contact Information
Connecticut
Yale New Haven Hospital, New Haven, Connecticut, 06520, United States; Recruiting
Washington
University of Washington, Seattle, Washington, 02195, United States; Recruiting
Kalpana Gupta, MD, MPH, Principal Investigator, Yale University
More Information
Last Updated: August 8, 2005
Record first received: August 5, 2005
ClinicalTrials.gov Identifier: NCT00128128
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-23

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