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

NCT ID: NCT00100061

Last Updated: 2013-03-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2013-07-31

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.

Conditions

Urinary Tract Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Cranberry Juice

Cranberry Juice provided by Ocean Spray

Group Type: ACTIVE_COMPARATOR

Cranberry juice

Intervention Type: DRUG

liquid juice taken daily

Cranberry Juice

Intervention Type: DIETARY_SUPPLEMENT

Taken orally

Placebo cranberry juice

Taken orally

Group Type: PLACEBO_COMPARATOR

Placebo cranberry juice

Intervention Type: DIETARY_SUPPLEMENT

Placebo comparitor

Interventions

Cranberry juice

liquid juice taken daily

Intervention Type: DRUG

Cranberry Juice

Taken orally

Intervention Type: DIETARY_SUPPLEMENT

Placebo cranberry juice

Placebo comparitor

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Office of Dietary Supplements (ODS)

NIH

Sponsor Role: collaborator

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lynn Stothers, MD

Role: PRINCIPAL_INVESTIGATOR

Bladder Care Centre, University of British Columbia

Locations

Bladder Care Centre, University of British Columbia

Vancouver, British Columbia, Canada

Countries

Canada

References

Williams G, Stothart CI, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Nov 10;11(11):CD001321. doi: 10.1002/14651858.CD001321.pub7.

Reference Type: DERIVED

PMID: 37947276 (View on PubMed)

Williams G, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Apr 17;4(4):CD001321. doi: 10.1002/14651858.CD001321.pub6.

Reference Type: DERIVED

PMID: 37068952 (View on PubMed)

Other Identifiers

R01AT002090-01

Identifier Type: NIH

Identifier Source: org_study_id

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