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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Biofortis Clinical Research
Information provided by (Responsible Party):
Ocean Spray Cranberries, Inc.
ClinicalTrials.gov Identifier:
NCT01776021
First received: January 23, 2013
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Urinary Tract Infections
Infection
Urologic Diseases
Other: cranberry juice
Other: placebo beverage

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Ocean Spray Cranberries, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 330
Study Start Date: January 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01776021

Locations
United States, Arizona
Chandler, Arizona, United States, 85224
Scottsdale, Arizona, United States, 85251
United States, California
San Diego, California, United States, 92123
Santa Rosa, California, United States, 95405
United States, Colorado
Denver, Colorado, United States, 80239
United States, Florida
Edgewater, Florida, United States, 32123
Miami, Florida, United States, 33155
Summerfield, Florida, United States, 34491
United States, Illinois
Ocean Spray Cranberries Research Sites
Addison, Illinois, United States, 60101
Evanston, Illinois, United States, 60201
United States, Minnesota
Edina, Minnesota, United States, 55435
United States, Ohio
Cincinnati, Ohio, United States, 45249
Columbus, Ohio, United States, 43212
United States, South Carolina
Anderson, South Carolina, United States, 29621
United States, Texas
Dallas, Texas, United States, 75231
United States, Utah
Pleasant Grove, Utah, United States, 84062
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
Ocean Spray Cranberries, Inc.
Biofortis Clinical Research
Investigators
Study Director: Kevin Maki, PhD Biofortis Clinical Research
  More Information

No publications provided

Responsible Party: Ocean Spray Cranberries, Inc.
ClinicalTrials.gov Identifier: NCT01776021     History of Changes
Other Study ID Numbers: PRV-1201
Study First Received: January 23, 2013
Last Updated: November 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Ocean Spray Cranberries, Inc.:
Urinary tract infection
Recurrent urinary tract infection
Cranberry
Prevention
E-coli

Additional relevant MeSH terms:
Urinary Tract Infections
Urologic Diseases
Infection

ClinicalTrials.gov processed this record on August 21, 2014