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

Condition	Treatment or Intervention	Phase
Urinary Tract Infection	Drug: Cranberry juice cocktail  Drug: Cranberry tablets	Phase II

Further Study Details: 

Primary Outcomes: Minimum dose of cranberry-containing product necessary to achieve a 30% prophylaxis of UTIs in women with recurrent UTIs; Whether the degree of UTI prophylaxis is related to the dose of cranberry-containing product (dose response curve); Whether proanthocyanidin concentration in the urine correlates with UTI prophylaxis
Expected Total Enrollment:  350

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.

Ages Eligible for Study:  19 Years and above,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

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

Faith Gagnon, HBSc      604-536-2996    faith.gagnon@telus.net
Lynn Stothers, MD      604-822-7616    lynns@interchange.ubc.ca

Canada, British Columbia
      Bladder Care Centre, University of British Columbia, Vancouver,  British Columbia,  V6T 2B5,  Canada

Study chairs or principal investigators

Lynn Stothers, MD,  Principal Investigator,  Bladder Care Centre, University of British Columbia   

Study ID Numbers:  1-R01-AT002090-01
Record last reviewed:  December 2004
Last Updated:  December 22, 2004
Record first received:  December 22, 2004
ClinicalTrials.gov Identifier:  NCT00100061
Health Authority: Canada: Health Canada (Awaiting confirmation); United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08