Urinary Tract Infections
Conditions
Keywords
Vaccinium macrocarpon, Cranberry, Complementary Therapies
Brief summary
This study will determine whether cranberry juice is effective in reducing recurrent urinary tract infections (UTIs) in women who have had a UTI within the past year.
Detailed description
UTIs are a common problem among young women, resulting in considerable morbidity and health care costs. Increasing resistance to antibiotics is making treatment of these infections even more problematic. Therefore, safe and effective nonantimicrobial prevention strategies are needed. One approach that appears to be effective is the use of cranberry products. However, data on the safety and effectiveness of cranberry products are limited. This study will determine whether cranberry juice can reduce UTIs in women. Participants will be randomly assigned to receive either cranberry juice or a placebo drink daily for 6 months. Study visits will occur every month for the 6-month treatment phase of the study. At study entry and at each study visit, urine collection will occur and vaginal swabs will be taken. A rectal swab will be taken at study entry and at the Month 2 and 4 visits. Participants will be asked about medication usage, any side effects they may be experiencing, and diet at each study visit. If participants develop a UTI at any time during the study, they will be asked to visit the study site within 24 hours.
Interventions
Participants will consume 4 or 8 ounces of Cranberry Juice Cocktail or Placebo daily for 6 months.
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* At least one UTI within 12 months prior to study entry * Premenopausal * Agree to avoid all foods that contain plants from the genus Vaccinium (related to cranberries) for the duration of the study
Exclusion criteria
* Anatomic abnormalities of the urinary tract * History of kidney stones * Bacteria in the urine (bacteriuria) * Use of prophylactic antibiotics within 7 days prior to study entry * Use of investigational drugs within 30 days prior to study entry * Current use of warfarin * Diabetes * Cancer. Participants with skin cancer are not excluded. * Allergy or intolerance of cranberry products * Symptomatic vaginitis * Pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of UTIs | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Compliance | 6 months |
| vaginal and rectal colonization with E. coli | 6 months |
Countries
United States
Outcome results
None listed