Cranberry Juice for the Prevention of Recurrent Urinary Tract Infections

May 14, 2015 updated by: National Center for Complementary and Integrative Health (NCCIH)

Cranberry and Prevention of UTI A Comprehensive Approach

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

176

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale New Haven Hospital
    • Washington
      • Seattle, Washington, United States, 02195
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of UTIs
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Compliance
Time Frame: 6 months
6 months
vaginal and rectal colonization with E. coli
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Kalpana Gupta, MD, MPH, Boston University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

August 5, 2005

First Submitted That Met QC Criteria

August 5, 2005

First Posted (Estimate)

August 9, 2005

Study Record Updates

Last Update Posted (Estimate)

June 4, 2015

Last Update Submitted That Met QC Criteria

May 14, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01AT002105-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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