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

Phase 2

• Conditions: Urinary Tract Infection
• Interventions: Dietary Supplement: Placebo cranberry juice; Dietary Supplement: Cranberry Juice

• Registration Number: NCT00100061
• Lead Sponsor: National Center for Complementary and Integrative Health (NCCIH)

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.

Study Timeline

• Study First Submitted: 2004-12-22
• Study First Submitted QC: 2004-12-22
• Study First Posted: 2004-12-23
• Study Start: 2007-05
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-11
• Last Update Posted: 2013-03-12
• Primary Completion: 2013-07
• Study Completion: 2013-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 350

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo cranberry juice	Placebo cranberry juice	Taken orally
Cranberry Juice	Cranberry Juice	Cranberry Juice provided by Ocean Spray

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Bladder Care Centre, University of British Columbia; 🇨🇦 Vancouver, British Columbia, Canada