Pilot Study: Dosing Study of Cranberry Capsules for the Prevention of Bacteriuria in Nursing Home Residents
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 14
- 主要终点
- E.Coli Bacteriuria Plus Pyuria
研究概览
简要总结
This study will investigate whether there is a particular dose of cranberry capsules that is effective in preventing the occurrence of urinary tract infections in females at least 65 years of age or older who live in a nursing home and who have a history of urinary tract infections. The Yale research team will be enrolling 80 subjects in total over several nursing home locations within Connecticut.
详细描述
Each subject was enrolled after providing a baseline urine specimen. Cranberry/placebo capsules were consumed for 30 days. Urine specimens were obtained weekly for 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female nursing home residents 65 years of age or older with history of urinary tract infection within the past year.
排除标准
- •residents that are not expected to be in the nursing home for at least one month (i.e., short term rehabilitation, pending discharge, terminal [life expectancy < 1 month]);
- •residents who are on chronic suppressive antibiotic or anti-infective (i.e., mandelamine) therapy for recurrent UTI;
- •residents with end stage renal disease on dialysis (they do not regularly produce urine);
- •residents unable to produce a baseline clean catch urine specimen for collection;
- •residents on warfarin therapy because of a potential interaction of warfarin and cranberry juice;
- •residents with a history of nephrolithiasis because cranberry may increase the risk of nephrolithiasis.
研究组 & 干预措施
3 cranberry capsules
3 active cranberry capsules qd
干预措施: Cranberry Capsule (Dietary Supplement)
3 placebo capsules
3 placebo capsules qd
干预措施: Placebo (Dietary Supplement)
1 cranberry capsule & 2 placebo capsules
1 active cranberry capsule and 2 placebo capsules qd
干预措施: Placebo (Dietary Supplement)
1 cranberry capsule & 2 placebo capsules
1 active cranberry capsule and 2 placebo capsules qd
干预措施: Cranberry Capsule (Dietary Supplement)
2 cranberry capsules & 1 placebo capsule
2 active cranberry capsules and 1 placebo capsules qd
干预措施: Placebo (Dietary Supplement)
2 cranberry capsules & 1 placebo capsule
2 active cranberry capsules and 1 placebo capsules qd
干预措施: Cranberry Capsule (Dietary Supplement)
结局指标
主要结局
E.Coli Bacteriuria Plus Pyuria
时间窗: One month
The number of urine cultures and urinalyses (obtained weekly) found with \>100,000 CFU/ml growth of E.coli and \>10 WBC.
次要结局
- Other Bacteriuria Plus Pyuria(one month)
- Not Growth(one month)