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临床试验/NCT00128128
NCT00128128已完成2 期

Cranberry and Prevention of UTI A Comprehensive Approach

National Center for Complementary and Integrative Health (NCCIH)2 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2005年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
176
试验地点
2
主要终点
Rate of UTIs

研究概览

简要总结

This study will determine whether cranberry juice is effective in reducing recurrent urinary tract infections (UTIs) in women who have had a UTI within the past year.

详细描述

UTIs are a common problem among young women, resulting in considerable morbidity and health care costs. Increasing resistance to antibiotics is making treatment of these infections even more problematic. Therefore, safe and effective nonantimicrobial prevention strategies are needed. One approach that appears to be effective is the use of cranberry products. However, data on the safety and effectiveness of cranberry products are limited. This study will determine whether cranberry juice can reduce UTIs in women.

Participants will be randomly assigned to receive either cranberry juice or a placebo drink daily for 6 months. Study visits will occur every month for the 6-month treatment phase of the study. At study entry and at each study visit, urine collection will occur and vaginal swabs will be taken. A rectal swab will be taken at study entry and at the Month 2 and 4 visits. Participants will be asked about medication usage, any side effects they may be experiencing, and diet at each study visit. If participants develop a UTI at any time during the study, they will be asked to visit the study site within 24 hours.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • At least one UTI within 12 months prior to study entry
  • Premenopausal
  • Agree to avoid all foods that contain plants from the genus Vaccinium (related to cranberries) for the duration of the study

排除标准

  • Anatomic abnormalities of the urinary tract
  • History of kidney stones
  • Bacteria in the urine (bacteriuria)
  • Use of prophylactic antibiotics within 7 days prior to study entry
  • Use of investigational drugs within 30 days prior to study entry
  • Current use of warfarin
  • Cancer. Participants with skin cancer are not excluded.
  • Allergy or intolerance of cranberry products
  • Symptomatic vaginitis
  • Pregnant or breastfeeding

研究组 & 干预措施

Arm 3

Placebo Comparator

Placebo- 4 ounces

干预措施: Cranberry juice cocktail (Drug)

Arm 1

Active Comparator

Cranberry Juice Cocktail- 4 ounces

干预措施: Cranberry juice cocktail (Drug)

Arm 2

Active Comparator

Cranberry Juice Cocktail-8 ounces

干预措施: Cranberry juice cocktail (Drug)

Arm 4

Placebo Comparator

Placebo- 8 ounces

干预措施: Cranberry juice cocktail (Drug)

结局指标

主要结局

Rate of UTIs

时间窗: 6 months

次要结局

  • vaginal and rectal colonization with E. coli(6 months)
  • Compliance(6 months)

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (2)

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