Cranberry Juice for the Prevention of Recurrent Urinary Tract Infections

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00128128
First received: August 5, 2005
Last updated: March 11, 2013
Last verified: March 2013
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Cranberry and Prevention of UTI A Comprehensive Approach

Resource links provided by NLM:


Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:
  • Rate of UTIs [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compliance [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • vaginal and rectal colonization with E. coli [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 176
Study Start Date: August 2005
Study Completion Date: June 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
4 ounces
Drug: Cranberry juice cocktail
4 or 8 ounces of CJC vs placebo
Other Names:
  • CJC
  • cranberry
Active Comparator: 2
8 ounces
Drug: Cranberry juice cocktail
4 or 8 ounces of CJC vs placebo
Other Names:
  • CJC
  • cranberry
Placebo Comparator: 3
4 ounces
Drug: Cranberry juice cocktail
4 or 8 ounces of CJC vs placebo
Other Names:
  • CJC
  • cranberry
Placebo Comparator: 4
8 ounces
Drug: Cranberry juice cocktail
4 or 8 ounces of CJC vs placebo
Other Names:
  • CJC
  • cranberry

Detailed Description:

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 to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00128128

Locations
United States, Connecticut
Yale New Haven Hospital
New Haven, Connecticut, United States, 06520
United States, Washington
University of Washington
Seattle, Washington, United States, 02195
Sponsors and Collaborators
Investigators
Principal Investigator: Kalpana Gupta, MD, MPH Boston University
  More Information

No publications provided by National Center for Complementary and Alternative Medicine (NCCAM)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier: NCT00128128     History of Changes
Other Study ID Numbers: R01 AT002105-01
Study First Received: August 5, 2005
Last Updated: March 11, 2013
Health Authority: United States: Food and Drug Administration
United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
Vaccinium macrocarpon
Cranberry
Complementary Therapies

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases

ClinicalTrials.gov processed this record on July 24, 2014