Clinical trial NCT00128128: Cranberry Juice for the Prevention of Recurrent Urinary Tract Infections
Official title: Cranberry and Prevention of UTI A Comprehensive Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Urinary Tract Infections
Keywords: Vaccinium macrocarpon
Cranberry
Complementary Therapies
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2005-08-09
Enrollment: 176
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of UTIs
timeFrame: 6 months
Secondary outcomes:
measure: Compliance
timeFrame: 6 months
measure: vaginal and rectal colonization with E. coli
timeFrame: 6 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Boston University
name: Kalpana Gupta, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stapleton AE, Dziura J, Hooton TM, Cox ME, Yarova-Yarovaya Y, Chen S, Gupta K. Recurrent urinary tract infection and urinary Escherichia coli in women ingesting cranberry juice daily: a randomized controlled trial. Mayo Clin Proc. 2012 Feb;87(2):143-50. doi: 10.1016/j.mayocp.2011.10.006.