Safety, and Effectiveness of Lactobacillus Reuteri for the Treatment of Urinary Tract Infections in Women: A Pilot Randomized Clinical Trial (RCT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- clinical and bacteriological cure
研究概览
简要总结
RCT to evaluate the safety and efficacy of Lactobacillus reuteri DSM 16666 & Lactobacillus reuteri DSM 17938 to significantly modify the frequency of clinical or bacteriological cure in women with non complicated acute cystitis who receive probiotics for 12 days compared with the frequency in women who receive placebo.
详细描述
Randomized, double blind, placebo controlled, pilot trial to evaluate the safety and efficacy of L. reuteri in non menopausal women with non complicated cystitis in terms of the frequency of clinical or bacteriological cure. Secondary outcomes will be a) time to clinical/laboratory relapse in at least 70% of women with non complicated acute cystitis who receive probiotics for 12 days compared with the time in women who receive placebo; b) frequency of clinical/laboratory and bacteriologic relapse in women with non complicated acute cystitis who receive probiotics for 12 days compared with the frequency in women who receive placebo, at day 30 after treatment start and c) frequency of adverse related events in women with non complicated acute cystitis who receive probiotics for 12 days compared with the frequency in women who receive placebo. In the active product we will use 5*10^8 CFU of Lactobacillus reuteri DSM 16666 & Lactobacillus reuteri DSM 17938 + cranberry extract. The control group will recibe Cranberry extract. The products will be taken twice per day, morning and evening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Non pregnant pre menopausal women
- •Minimum age 18 years
- •Uncomplicated cystitis diagnosed by urine dipstick testing (nitrates +, leukocytes esterase
- •and/or 105 CFU/ml or nitrates +, leukocytes esterase + and/or 102 -103 CFU/ml+ clinical symptoms) and an evaluation of the presence of typical related symptoms. In particular, frequency (frequent voiding of urine), urgency (the urge to void immediately), dysuria (painful voiding), and/or suprapubic pain.
- •Verbal and Written Informed Consent for participation in the study
排除标准
- •Acute cystitis symptoms for >1week before the first visit
- •Diabetes mellitus,
- •Congenital urinary tract abnormality
- •Lactating women
- •Female who intend to become pregnant during the study or within 3 months after the completion of the study
- •Vaginal discharge + fever (>37.5oC)
- •Diagnostic of sexually transmitted diseases
- •Use of an indwelling catheter or an intermittent self-catheterisation program
- •Presence of neurogenic bladder, or
- •Use of any antibiotic 2 weeks before Day 1 in the study.
结局指标
主要结局
clinical and bacteriological cure
时间窗: 30 days
Frequency of clinical or bacteriological cure in women with non complicated acute cystitis who receive probiotics for 12 days compared with the frequency in women who receive placebo
次要结局
- clinical or bacteriological relapse(30 days)
- Adverse events(14 days)
研究者
Pedro Gutierrez Castrellon
MD, MSc, DSc
Innovacion y Desarrollo de Estrategias en Salud