A Randomized Double Blinded Study of Probiotic Bladder Instillation for Prevention of Catheter Associated UTIs in Chronically Catheterized Patients
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 发起方
- Lahey Clinic
- 主要终点
- Bladder colonization with Lactobacillus
研究概览
简要总结
The proposed study is a randomized, placebo-controlled clinical trial to test the efficacy of an oral Lactobacillus product dissolved in sterile saline and instilled into the urinary bladder in an attempt to colonize the urinary bladder as well as prevent UTIs.
详细描述
Patients who use a chronic indwelling urinary catheter to drain their bladder will be randomized to receive intravesical instillations of a Lactobacillus solution or sterile saline at the time of a scheduled monthly catheter exchange. Bacterial colonization and frequency of urinary tract infections will be compared between the two groups.
The Lactobacillus solution will be derived from the combination of Lactobacillus rhamnosus (GR-1®) and reuteri (RC-14®) species, which is offered as an over the counter probiotic capsule sold under the brand name of Femdophilus and manufactured by CHR-Hansen of Denmark (phone: +45 45747474; email: info@chr-hansen.com). The contents of the capsules will be dissolved in 50 mL of normal saline at room temperature within one hour prior to administration and left indwelling in the patient's urinary bladder for 30 minutes.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥ 18 years of age
- •Chronic indwelling urethral catheter or supra-pubic tube for >6 months
- •Prior symptomatic UTI while catheter in place
排除标准
- •Immunosuppressed (HIV, transplant immunosuppression, uncontrolled diabetes)
- •Active infection (may be considered after treatment of active infection)
- •Prior urosepsis requiring ICU admission
- •Significant gross hematuria resulting from catheter exchanges
- •Supravesical urinary diversion
- •Upper urinary tract anatomical abnormality
- •Obstructing urolithiasis
- •Ongoing antibiotic therapy for non-urological infection
- •Indwelling nephrostomy tube or ureteral stent
- •Radiation cystitis
结局指标
主要结局
Bladder colonization with Lactobacillus
时间窗: 6 months
Percent of patients with urine cultures positive for lactobacilli species after 6 months.
次要结局
未报告次要终点