Effects of Cranberry-Containing Products in Women With Recurrent Urinary Tract Infections (UTIs)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00100061
First received: December 22, 2004
Last updated: March 11, 2013
Last verified: March 2013
  Purpose

The purpose of this study is to determine the role of cranberry-containing products in preventing urinary tract infections (UTIs).


Condition Intervention Phase
Urinary Tract Infection
Drug: Cranberry juice
Dietary Supplement: Cranberry Juice
Dietary Supplement: Placebo cranberry juice
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Dose Response to Cranberry of Women With Recurrent UTIs

Resource links provided by NLM:


Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:
  • Minimum dose of cranberry-containing product necessary to achieve a 30% prophylaxis of UTIs in women with recurrent UTIs [ Time Frame: end of study ] [ Designated as safety issue: No ]
    recurrence of UTI

  • Whether the degree of UTI prophylaxis is related to the dose of cranberry-containing product (dose response curve) [ Time Frame: end of study ] [ Designated as safety issue: No ]
    comparison of UTI occurrence

  • Whether proanthocyanidin concentration in the urine correlates with UTI prophylaxis [ Time Frame: end of study ] [ Designated as safety issue: No ]
    recurrence of UTI and lab results


Estimated Enrollment: 350
Study Start Date: May 2007
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cranberry Juice
Cranberry Juice provided by Ocean Spray
Drug: Cranberry juice
liquid juice taken daily
Dietary Supplement: Cranberry Juice
Taken orally
Placebo Comparator: Placebo cranberry juice
Taken orally
Dietary Supplement: Placebo cranberry juice
Placebo comparitor

Detailed Description:

Although cranberry-containing products are commonly taken to prevent UTIs and other urinary symptoms, an optimally effective dose has not been established, and the chemicals responsible for the UTI-preventing properties in cranberry-containing products have yet to be determined. This study will determine the minimum dose of cranberry-containing product necessary to prevent UTIs, the effectiveness of cranberry-containing products in fighting different strains of E. coli, and the long-term effects of cranberry-containing product consumption. This study will also determine whether plant pigments called proanthocyanidins influence the UTI-preventing properties of cranberry-containing products.

This study will last 2 years. Participants will be randomly assigned to receive varying doses of either cranberry-containing products or placebo for 1 year. Some participants will receive cranberry or placebo supplement tablets; others will receive cranberry juice or a placebo beverage. Clinic visits will occur every 2 months; urine collection will occur at each visit. Some participants will be asked to collect 24-hour urine samples every 8 weeks and provide urine samples on Days 1, 3, 5 and 7.

Laboratory tests will be used to assess participants during the study. A 3-day course of antibiotics will be provided to participants developing a UTI during the course of the study. Telephone interview follow-up at 6 and 12 months after the study will determine whether cranberry-containing product use has continued and whether UTIs have recurred.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • At least two UTIs in the year prior to study entry
  • Willing to use acceptable methods of contraception
  • Willing to refrain from consuming other forms of cranberry supplementation

Exclusion Criteria:

  • Current UTI
  • Allergy to cranberry-containing products
  • Active urinary stone disease
  • Insulin-dependent diabetes
  • Immunosuppressive disease
  • Current corticosteroid use
  • Intermittent or indwelling catheterization
  • Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00100061

Locations
Canada, British Columbia
Bladder Care Centre, University of British Columbia
Vancouver, British Columbia, Canada, V6T 2B5
Sponsors and Collaborators
Investigators
Principal Investigator: Lynn Stothers, MD Bladder Care Centre, University of British Columbia
  More Information

No publications provided

Responsible Party: National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier: NCT00100061     History of Changes
Other Study ID Numbers: R01 AT002090-01
Study First Received: December 22, 2004
Last Updated: March 11, 2013
Health Authority: Canada: Health Canada
United States: Federal Government
United States: Food and Drug Administration

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
Cranberry
Vaccinium macrocarpon

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases

ClinicalTrials.gov processed this record on April 23, 2014