Urinary Tract Infection
Conditions
Keywords
Cranberry, Vaccinium macrocarpon
Brief summary
The purpose of this study is to determine the role of cranberry-containing products in preventing urinary tract infections (UTIs).
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.
Interventions
DRUGCranberry juice
liquid juice taken daily
DIETARY_SUPPLEMENTCranberry Juice
Taken orally
DIETARY_SUPPLEMENTPlacebo cranberry juice
Placebo comparitor
Sponsors
Office of Dietary Supplements (ODS)
National Center for Complementary and Integrative Health (NCCIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Minimum dose of cranberry-containing product necessary to achieve a 30% prophylaxis of UTIs in women with recurrent UTIs | end of study | recurrence of UTI |
| Whether the degree of UTI prophylaxis is related to the dose of cranberry-containing product (dose response curve) | end of study | comparison of UTI occurrence |
| Whether proanthocyanidin concentration in the urine correlates with UTI prophylaxis | end of study | recurrence of UTI and lab results |
Countries
Canada
Outcome results
None listed