Cranberry Juice for the Prevention of Recurrent Urinary Tract Infections

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cranberry and Prevention of UTI A Comprehensive Approach

Conditions
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Urinary Tract Infections

Intervention / Treatment
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* Drug: Cranberry juice cocktail


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br>Cranberry Juice Cocktail- 4 ounces | Drug: Cranberry juice cocktail<br>* Participants will consume 4 or 8 ounces of Cranberry Juice Cocktail or Placebo daily for 6 months.<br>* Other names: cranberry;|
| Active Comparator: Arm 2<br>Cranberry Juice Cocktail-8 ounces | Drug: Cranberry juice cocktail<br>* Participants will consume 4 or 8 ounces of Cranberry Juice Cocktail or Placebo daily for 6 months.<br>* Other names: cranberry;|
| Placebo Comparator: Arm 3<br>Placebo- 4 ounces | Drug: Cranberry juice cocktail<br>* Participants will consume 4 or 8 ounces of Cranberry Juice Cocktail or Placebo daily for 6 months.<br>* Other names: cranberry;|
| Placebo Comparator: Arm 4<br>Placebo- 8 ounces | Drug: Cranberry juice cocktail<br>* Participants will consume 4 or 8 ounces of Cranberry Juice Cocktail or Placebo daily for 6 months.<br>* Other names: cranberry;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of UTIs |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance |  | 6 months | 
| vaginal and rectal colonization with E. coli |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaccinium macrocarpon, Cranberry, Complementary Therapies