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

National Institutes of Health (NIH)

Status and phase: Unknown; Phase 2

Conditions: Urinary Tract Infection

Treatments: Drug: Cranberry juice; Dietary Supplement: Placebo cranberry juice; Dietary Supplement: Cranberry Juice

Study type: Interventional

Funder types: NIH

Identifiers

NCT00100061

R01AT002090-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 350 estimated patients

Sex: Female

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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350 participants in 2 patient groups, including a placebo group

Cranberry Juice

Active Comparator group

Description:

Cranberry Juice provided by Ocean Spray

Treatment:

Dietary Supplement: Cranberry Juice

Drug: Cranberry juice

Placebo cranberry juice

Placebo Comparator group

Description:

Taken orally

Treatment:

Dietary Supplement: Placebo cranberry juice