Urinary Tract Infection Clinical Trial
Official title:
Dose Response to Cranberry of Women With Recurrent UTIs
The purpose of this study is to determine the role of cranberry-containing products in preventing urinary tract infections (UTIs).
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
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