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Cranberry Juice for the Prevention of Recurrent Urinary Tract Infections

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ClinicalTrials.gov Identifier: NCT00128128
Recruitment Status : Completed
First Posted : August 9, 2005
Last Update Posted : June 4, 2015
Sponsor:
Information provided by (Responsible Party):
National Center for Complementary and Integrative Health (NCCIH)

Brief Summary:
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 or disease Intervention/treatment Phase
Urinary Tract Infections Drug: Cranberry juice cocktail Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Cranberry and Prevention of UTI A Comprehensive Approach
Study Start Date : August 2005
Actual Primary Completion Date : December 2008
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Arm 1
Cranberry Juice Cocktail- 4 ounces
Drug: Cranberry juice cocktail
Participants will consume 4 or 8 ounces of Cranberry Juice Cocktail or Placebo daily for 6 months.
Other Names:
  • CJC
  • cranberry
Active Comparator: Arm 2
Cranberry Juice Cocktail-8 ounces
Drug: Cranberry juice cocktail
Participants will consume 4 or 8 ounces of Cranberry Juice Cocktail or Placebo daily for 6 months.
Other Names:
  • CJC
  • cranberry
Placebo Comparator: Arm 3
Placebo- 4 ounces
Drug: Cranberry juice cocktail
Participants will consume 4 or 8 ounces of Cranberry Juice Cocktail or Placebo daily for 6 months.
Other Names:
  • CJC
  • cranberry
Placebo Comparator: Arm 4
Placebo- 8 ounces
Drug: Cranberry juice cocktail
Participants will consume 4 or 8 ounces of Cranberry Juice Cocktail or Placebo daily for 6 months.
Other Names:
  • CJC
  • cranberry



Primary Outcome Measures :
  1. Rate of UTIs [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Compliance [ Time Frame: 6 months ]
  2. vaginal and rectal colonization with E. coli [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Kalpana Gupta, MD, MPH Boston University

Publications of Results:
Responsible Party: National Center for Complementary and Integrative Health (NCCIH)
ClinicalTrials.gov Identifier: NCT00128128     History of Changes
Other Study ID Numbers: R01AT002105-01 ( U.S. NIH Grant/Contract )
First Posted: August 9, 2005    Key Record Dates
Last Update Posted: June 4, 2015
Last Verified: May 2015

Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
Vaccinium macrocarpon
Cranberry
Complementary Therapies

Additional relevant MeSH terms:
Infection
Urinary Tract Infections
Urologic Diseases