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Trial record 4 of 45 for:    Completed Studies | cranberry

Cranberry Juice for the Prevention of Recurrent Urinary Tract Infections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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)

Tracking Information
First Submitted Date  ICMJE August 5, 2005
First Posted Date  ICMJE August 9, 2005
Last Update Posted Date June 4, 2015
Study Start Date  ICMJE August 2005
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2008)
Rate of UTIs [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 5, 2005)
Rate of UTIs
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2008)
  • Compliance [ Time Frame: 6 months ]
  • vaginal and rectal colonization with E. coli [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 5, 2005)
  • Colonization of vaginal and rectal flora
  • vaginal and rectal colonization with E. coli
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cranberry Juice for the Prevention of Recurrent Urinary Tract Infections
Official Title  ICMJE Cranberry and Prevention of UTI A Comprehensive Approach
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Urinary Tract Infections
Intervention  ICMJE 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
Study Arms  ICMJE
  • Active Comparator: Arm 1
    Cranberry Juice Cocktail- 4 ounces
    Intervention: Drug: Cranberry juice cocktail
  • Active Comparator: Arm 2
    Cranberry Juice Cocktail-8 ounces
    Intervention: Drug: Cranberry juice cocktail
  • Placebo Comparator: Arm 3
    Placebo- 4 ounces
    Intervention: Drug: Cranberry juice cocktail
  • Placebo Comparator: Arm 4
    Placebo- 8 ounces
    Intervention: Drug: Cranberry juice cocktail
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 11, 2013)
176
Original Enrollment  ICMJE
 (submitted: August 5, 2005)
350
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00128128
Other Study ID Numbers  ICMJE R01AT002105-01( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Center for Complementary and Integrative Health (NCCIH)
Study Sponsor  ICMJE National Center for Complementary and Integrative Health (NCCIH)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kalpana Gupta, MD, MPH Boston University
PRS Account National Center for Complementary and Integrative Health (NCCIH)
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP