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Cranberry Juice for the Prevention of Recurrent Urinary Tract Infections - Article


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Biliary Tract Diseases


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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

Sponsored by: National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by: National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier: NCT00128128

Purpose

This study will determine whether cranberry juice is effective in reducing recurrent urinary tract infections (UTIs) in women who have had a UTI within the past year.
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

Further Study Details: 
Primary Outcomes: Rate of UTIs
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

Ages Eligible for Study:  18 Years   -   45 Years,  Genders Eligible for Study:  Female
Criteria

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00128128


Connecticut
      Yale New Haven Hospital, New Haven,  Connecticut,  06520,  United States; Recruiting
Laurie Feldman, MHSA  203-764-6623    laurie.feldman@yale.edu 

Washington
      University of Washington, Seattle,  Washington,  02195,  United States; Recruiting
Niki DeShaw, MS  206-685-1048    ndeshaw@u.washington.edu 

Study chairs or principal investigators

Kalpana Gupta, MD, MPH,  Principal Investigator,  Yale University   

More Information

Study ID Numbers:  R01AT002105-01
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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November 23, 2008



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