NCT00100061

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

Dose Response to Cranberry of Women With Recurrent UTIs

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: National Center for Complementary and Integrative Health (NCCIH) · NIH
• Sex: Female
• Age: 19 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Cranberry juice	liquid juice taken daily
DIETARY_SUPPLEMENT	Cranberry Juice	Taken orally
DIETARY_SUPPLEMENT	Placebo cranberry juice	Placebo comparitor

Timeline

• Start date: 2007-05-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2004-12-23
• Last updated: 2013-03-12

Locations

1 site across 1 country: Canada