Effects of a Cranberry Beverage on Women With Recent History of Urinary Tract Infections

April 24, 2015 updated by: Ocean Spray Cranberries, Inc.

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial to Assess the Effects of a Cranberry Beverage on Women With Recent History of Urinary Tract Infections

The purpose of this study is to compare the effects of a cranberry juice beverage on rates of Urinary tract infection (UTI) recurrence in women with a history of UTI.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Urinary tract infections (UTI) are the second most common infection of any organ system and the most common urological disease in the United States, with a total annual cost of more than $3.5 billion. Although UTIs can occur in both men and women, they are about 50 times more common in adult women than adult men. It is estimated that 25% of women diagnosed with a primary UTI will suffer a recurrence within two to three months. While no universal definition has been accepted, recurrent UTI is usually defined as three episodes in the last 12 months or two episodes in the last six months following initial infection. In an estimated 75 to 95% of cases of uncomplicated UTI, Escherichia coli (E. coli) is the underlying cause.

Cranberries have historically been associated with urinary tract health, but only recently has the biologic plausibility of cranberry use in the prevention of UTI been addressed. Current research suggests that A-type proanthocyanidins, a specific class of polyphenolic compounds found uniquely abundant in cranberries, inhibit adhesion of bacteria (including multidrug resistant E.coli) to cultured epithelial cells of the urinary tract.

This study will compare the effects of a cranberry juice beverage vs placebo on rates of UTI recurrence in women with a history of UTI.

Study Type

Interventional

Enrollment (Actual)

330

Phase

  • Not Applicable

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
    • Arizona
      • Chandler, Arizona, United States, 85224
      • Scottsdale, Arizona, United States, 85251
    • California
      • San Diego, California, United States, 92123
      • Santa Rosa, California, United States, 95405
    • Colorado
      • Denver, Colorado, United States, 80239
    • Florida
      • Edgewater, Florida, United States, 32123
      • Miami, Florida, United States, 33155
      • Summerfield, Florida, United States, 34491
    • Illinois
      • Addison, Illinois, United States, 60101
        • Ocean Spray Cranberries Research Sites
      • Evanston, Illinois, United States, 60201
    • Minnesota
      • Edina, Minnesota, United States, 55435
    • Ohio
      • Cincinnati, Ohio, United States, 45249
      • Columbus, Ohio, United States, 43212
    • South Carolina
      • Anderson, South Carolina, United States, 29621
    • Texas
      • Dallas, Texas, United States, 75231
    • Utah
      • Pleasant Grove, Utah, United States, 84062
      • Salt Lake City, Utah, United States, 84124

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

20 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Subject has had at least 2 episodes of a UTI treated by a healthcare professional in the last year and at least 1 treated UTI within the last 6 months.
  2. Subject is willing to avoid listed Vaccinium products (including cranberry juice, cranberries, craisins, blueberries, cranberry/blueberry powders, pills, or supplements, probiotics) for 2 weeks prior to enrollment and throughout intervention.
  3. Subject agrees to avoid probiotic dietary supplements for 2 weeks prior to enrollment and throughout intervention.
  4. Subject agrees to limit all probiotic-containing foods/yogurt and yogurt-containing products to no more than an 8 oz serving/d within 2 weeks prior to enrollment and throughout intervention.
  5. Subject is willing to limit all soda, pop or energy drinks (diet or regular sweetened) to < 20 oz/d within 2 weeks prior to and throughout intervention.

Exclusion Criteria:

  1. Subject has an in-dwelling catheter, polycystic disease, interstitial cystitis, previous urological surgery, stones, or anatomical abnormalities of the urinary tract, spinal cord injury, immuno-compromised conditions, severe renal impairment, or multiple sclerosis.
  2. Subject has a history of antibiotic prophylaxis use for UTI. A 2-week washout period prior to enrollment will be allowed.
  3. Subject has a body mass index (BMI) >40.0 kg/m2.
  4. Subjects with diabetes mellitus and HbA1C >8.0% prior to enrollment.
  5. Subject has diabetes mellitus treated with insulin.
  6. Subject has an active infection or sign/symptoms of an infection (i.e., including a UTI).
  7. Subject has used oral anti-coagulants within the last 4 weeks.
  8. Subject has a history or presence of cancer in the prior two years, except for nonmelanoma skin cancer.
  9. Subject is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period.

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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: cranberry juice
cranberry juice beverage at a dose of one 8 oz. beverage per day for six months
Other: cranberry juice
cranberry juice beverage at a dose of one 8 oz. beverage per day for six months
PLACEBO_COMPARATOR: Placebo
placebo beverage at a dose of one 8 oz. beverage per day for six months
Other: placebo beverage
placebo beverage at a dose of one 8 oz. beverage per day for six months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary outcome variable will be UTI incidence density, defined as the semi-annualized number of UTIs in each group, adjusted for susceptible time under observation.
Time Frame: six months
six months

Secondary Outcome Measures

Outcome Measure
Time Frame
Time from randomization to first clinical UTI. Time from randomization to first clinical UTI w/ pyuria. Time from randomization to first clinical UTI w/ microbiological verification. The fraction of subjects w/ one or more episode(s) of clinical UTI.
Time Frame: six months
six months

Collaborators and Investigators

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

Sponsor

Ocean Spray Cranberries, Inc.

Collaborators

Biofortis Clinical Research, Inc.

Investigators

  • Study Director: Kevin Maki, PhD, Biofortis Clinical Research, Inc.

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

January 1, 2013

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

April 1, 2015

Study Registration Dates

First Submitted

January 23, 2013

First Submitted That Met QC Criteria

January 24, 2013

First Posted (ESTIMATE)

January 25, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

April 27, 2015

Last Update Submitted That Met QC Criteria

April 24, 2015

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRV-1201

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.

Clinical Trials on Urologic Diseases

Clinical Trials on cranberry juice

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malta

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe