Dose Response to Cranberry of Women With Recurrent UTIs
试验速览
- 阶段
- 2 期
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Minimum dose of cranberry-containing product necessary to achieve a 30% prophylaxis of UTIs in women with recurrent UTIs
研究概览
简要总结
The purpose of this study is to determine the role of cranberry-containing products in preventing urinary tract infections (UTIs).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Current UTI
- •Allergy to cranberry-containing products
- •Active urinary stone disease
- •Insulin-dependent diabetes
- •Immunosuppressive disease
- •Current corticosteroid use
- •Intermittent or indwelling catheterization
- •Pregnancy
研究组 & 干预措施
Cranberry Juice
Cranberry Juice provided by Ocean Spray
干预措施: Cranberry Juice (Dietary Supplement)
Placebo cranberry juice
Taken orally
干预措施: Placebo cranberry juice (Dietary Supplement)
结局指标
主要结局
Minimum dose of cranberry-containing product necessary to achieve a 30% prophylaxis of UTIs in women with recurrent UTIs
时间窗: end of study
recurrence of UTI
Whether the degree of UTI prophylaxis is related to the dose of cranberry-containing product (dose response curve)
时间窗: end of study
comparison of UTI occurrence
Whether proanthocyanidin concentration in the urine correlates with UTI prophylaxis
时间窗: end of study
recurrence of UTI and lab results
次要结局
未报告次要终点
