Induced Asymptomatic E. Coli 83972 Bacteriuria in Patients With Recurrent Urinary Tract Infections and Bladder Dysfunction- is There a Protective Effect Against Recurrent Symptomatic Infections? A Blinded Placebo Controlled Cross-over Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Time to UTI
研究概览
简要总结
This study tests the following hypothesis: Does induced asymptomatic bacteriuria (E. coli 83972) protect against symptomatic urinary tract infections in individuals with bladder emptying dysfunctions and prone to recurrent infection episodes? The study is performed using a double-blind randomized study protocol with a cross-over, with re-inoculations being patient-blinded (phase 1). After patients have fulfilled the cross-over, those who have had bacteriuria or placebo-periods < 12 months will be subjected to additional patient blinded inoculations (phase 2). During the entire study (phase 1+2) the study-team and the patients are unaware of urine culture results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recurrent UTI
- •Bladder emptying dysfunction
- •Optimal conservative treatment incl. clean intermittent catheterization
- •Capable of "self reporting of UTI episodes"
排除标准
- •Malignant disease
- •Immunosuppression
- •Recurrent pyelonephritis
- •Abnormalities within upper urinary tract, including renal stones and poor kidney function
研究组 & 干预措施
Active arm
E. coli 83972 bacteriuria
干预措施: E. coli 83972 (Biological)
Placebo arm
Monitoring
干预措施: E. coli 83972 (Biological)
结局指标
主要结局
Time to UTI
时间窗: 12 months
Number of UTI
时间窗: During 12 months placebo or active treatment
次要结局
未报告次要终点