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

Urinary Tract Infection Clinical Trial

Official title:

Dose Response to Cranberry of Women With Recurrent UTIs

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00100061
• Other study ID #: R01AT002090-01
• Status: Active, not recruiting
• Phase: Phase 2
• First received: December 22, 2004
• Last updated: March 11, 2013
• Start date: May 2007
• Est. completion date: July 2013

Study information

• Verified date: March 2013
• Source: National Center for Complementary and Integrative Health (NCCIH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaUnited States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 350
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Urinary Tract Infection
• Urinary Tract Infections

Intervention

Drug:
• Cranberry juice
liquid juice taken daily

Dietary Supplement:
• Cranberry Juice
Taken orally
• Placebo cranberry juice
Placebo comparitor

Locations

Country	Name	City	State
Canada	Bladder Care Centre, University of British Columbia	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)	Office of Dietary Supplements (ODS)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	Whether proanthocyanidin concentration in the urine correlates with UTI prophylaxis	recurrence of UTI and lab results	end of study	No