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

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ClinicalTrials.gov Identifier: NCT00100061
Recruitment Status : Unknown
Verified March 2013 by National Center for Complementary and Integrative Health (NCCIH).
Recruitment status was:  Active, not recruiting
First Posted : December 23, 2004
Last Update Posted : March 12, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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

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

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Dose Response to Cranberry of Women With Recurrent UTIs
Study Start Date : May 2007
Estimated Primary Completion Date : July 2013
Estimated Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Minimum dose of cranberry-containing product necessary to achieve a 30% prophylaxis of UTIs in women with recurrent UTIs [ Time Frame: end of study ]
    recurrence of UTI

  2. Whether the degree of UTI prophylaxis is related to the dose of cranberry-containing product (dose response curve) [ Time Frame: end of study ]
    comparison of UTI occurrence

  3. Whether proanthocyanidin concentration in the urine correlates with UTI prophylaxis [ Time Frame: end of study ]
    recurrence of UTI and lab results


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00100061


Locations
Canada, British Columbia
Bladder Care Centre, University of British Columbia
Vancouver, British Columbia, Canada, V6T 2B5
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Office of Dietary Supplements (ODS)
Investigators
Principal Investigator: Lynn Stothers, MD Bladder Care Centre, University of British Columbia
More Information

Responsible Party: National Center for Complementary and Integrative Health (NCCIH)
ClinicalTrials.gov Identifier: NCT00100061     History of Changes
Other Study ID Numbers: R01AT002090-01 ( U.S. NIH Grant/Contract )
First Posted: December 23, 2004    Key Record Dates
Last Update Posted: March 12, 2013
Last Verified: March 2013

Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
Cranberry
Vaccinium macrocarpon

Additional relevant MeSH terms:
Infection
Urinary Tract Infections
Urologic Diseases