Effects of Cranberry-Containing Products in Women With Recurrent Urinary Tract Infections (UTIs)

Study Overview
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Brief Summary
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The purpose of this study is to determine the role of cranberry-containing products in preventing urinary tract infections (UTIs).

Detailed Description
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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.

Official Title
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Dose Response to Cranberry of Women With Recurrent UTIs

Conditions
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Urinary Tract Infection

Intervention / Treatment
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* Drug: Cranberry juice
* Dietary Supplement: Cranberry Juice
* Dietary Supplement: Placebo cranberry juice


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cranberry Juice<br>Cranberry Juice provided by Ocean Spray | Drug: Cranberry juice<br>* liquid juice taken daily<br>Dietary Supplement: Cranberry Juice<br>* Taken orally<br>|
| Placebo Comparator: Placebo cranberry juice<br>Taken orally | Dietary Supplement: Placebo cranberry juice<br>* Placebo comparitor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimum dose of cranberry-containing product necessary to achieve a 30% prophylaxis of UTIs in women with recurrent UTIs | recurrence of UTI | end of study | 
| Whether the degree of UTI prophylaxis is related to the dose of cranberry-containing product (dose response curve) | comparison of UTI occurrence | end of study | 
| Whether proanthocyanidin concentration in the urine correlates with UTI prophylaxis | recurrence of UTI and lab results | end of study | 

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