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
|Condition or disease||Intervention/treatment||Phase|
|Urinary Tract Infection||Drug: Cranberry juice Dietary Supplement: Cranberry Juice Dietary Supplement: Placebo cranberry juice||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||350 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
Active Comparator: Cranberry Juice
Cranberry Juice provided by Ocean Spray
Drug: Cranberry juice
liquid juice taken daily
Dietary Supplement: Cranberry Juice
Placebo Comparator: Placebo cranberry juice
Dietary Supplement: Placebo cranberry juice
- 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
- 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
- Whether proanthocyanidin concentration in the urine correlates with UTI prophylaxis [ Time Frame: end of study ]recurrence of UTI and lab results
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
|Canada, British Columbia|
|Bladder Care Centre, University of British Columbia|
|Vancouver, British Columbia, Canada, V6T 2B5|
|Principal Investigator:||Lynn Stothers, MD||Bladder Care Centre, University of British Columbia|