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临床试验/NCT00100061
NCT00100061Unknown2 期

Dose Response to Cranberry of Women With Recurrent UTIs

National Center for Complementary and Integrative Health (NCCIH)1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2007年5月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

Cranberry Juice provided by Ocean Spray

干预措施: Cranberry Juice (Dietary Supplement)

Placebo cranberry juice

Placebo Comparator

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

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (1)

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