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Sponsors and Collaborators: |
National Center for Complementary and Alternative Medicine (NCCAM) Office of Dietary Supplements (ODS) |
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Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
ClinicalTrials.gov Identifier: | NCT00100061 |
The purpose of this study is to determine the role of cranberry-containing products in preventing urinary tract infections (UTIs).
Condition | Intervention | Phase |
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Urinary Tract Infection |
Drug: Cranberry juice cocktail Drug: Cranberry tablets |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Dose Response to Cranberry of Women With Recurrent UTIs |
Estimated Enrollment: | 350 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | July 2008 |
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 older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kenna Sleigh, HBSc | kenna@interchange.ubc.ca | |
Contact: Lynn Stothers, MD | 604-822-7616 | lynns@interchange.ubc.ca |
Canada, British Columbia | |
Bladder Care Centre, University of British Columbia | Recruiting |
Vancouver, British Columbia, Canada, V6T 2B5 | |
Contact: Kenna Sleigh 604-822-7616 kenna@interchange.ubc.ca | |
Contact: Lynn Stothers, MD 604-822-7616 lynns@interchange.ubc.ca | |
Principal Investigator: Lynn Stothers, MD, MPH |
Principal Investigator: | Lynn Stothers, MD | Bladder Care Centre, University of British Columbia |
Study ID Numbers: | R01 AT002090-01 |
Study First Received: | December 22, 2004 |
Last Updated: | April 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00100061 |
Health Authority: | Canada: Health Canada; United States: Federal Government; United States: Food and Drug Administration |
Cranberry Vaccinium macrocarpon |
Urologic Diseases Urinary Tract Infections Recurrence |
Communicable Diseases Infection |