Cranberry Juice for the Prevention of Recurrent Urinary Tract Infections
NCT ID: NCT00128128
Last Updated: 2015-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
176 participants
INTERVENTIONAL
2005-08-31
2009-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Arm 1
Cranberry Juice Cocktail- 4 ounces
Cranberry juice cocktail
Participants will consume 4 or 8 ounces of Cranberry Juice Cocktail or Placebo daily for 6 months.
Arm 2
Cranberry Juice Cocktail-8 ounces
Cranberry juice cocktail
Participants will consume 4 or 8 ounces of Cranberry Juice Cocktail or Placebo daily for 6 months.
Arm 3
Placebo- 4 ounces
Cranberry juice cocktail
Participants will consume 4 or 8 ounces of Cranberry Juice Cocktail or Placebo daily for 6 months.
Arm 4
Placebo- 8 ounces
Cranberry juice cocktail
Participants will consume 4 or 8 ounces of Cranberry Juice Cocktail or Placebo daily for 6 months.
Interventions
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Cranberry juice cocktail
Participants will consume 4 or 8 ounces of Cranberry Juice Cocktail or Placebo daily for 6 months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Premenopausal
* Agree to avoid all foods that contain plants from the genus Vaccinium (related to cranberries) for the duration of the study
Exclusion Criteria
* 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
18 Years
45 Years
FEMALE
No
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
Responsible Party
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Principal Investigators
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Kalpana Gupta, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Boston University
Locations
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Yale New Haven Hospital
New Haven, Connecticut, United States
University of Washington
Seattle, Washington, United States
Countries
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References
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Stapleton AE, Dziura J, Hooton TM, Cox ME, Yarova-Yarovaya Y, Chen S, Gupta K. Recurrent urinary tract infection and urinary Escherichia coli in women ingesting cranberry juice daily: a randomized controlled trial. Mayo Clin Proc. 2012 Feb;87(2):143-50. doi: 10.1016/j.mayocp.2011.10.006.
Williams G, Stothart CI, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Nov 10;11(11):CD001321. doi: 10.1002/14651858.CD001321.pub7.
Williams G, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Apr 17;4(4):CD001321. doi: 10.1002/14651858.CD001321.pub6.
Other Identifiers
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