A Double-blinded, Randomized, Placebo-controlled, Parallel-group Study Evaluating the Effect of the Probiotic on Recurrent Urinary Tract Infection (UTI) in Adult Women Recently Treated for UTI.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- BioGaia AB
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- To Evaluate the Effect of Oral Supplementation With Lactobacillus Reuteri on the Frequency of Confirmed UTI in Adult Women With Recurrent UTI.
研究概览
简要总结
Urinary tract infections (UTIs) are the most common bacterial infections in women, with about 50% of women experiencing at least one UTI in their lifetime.
The main pharmacological treatments of cystitis usually involve the use of antibiotics, in particular quinolones (such as ciprofloxacin and levofloxacin), fosfomycin, second-generation and third-generation cephalosporins, and b-lactam antibiotics associated with b-lactamase inhibitors.
详细描述
This is a double-blinded, randomized, placebo-controlled, parallel-group study evaluating the effect of the probiotic on recurrent urinary tract infection (UTI) in adult women recently treated for UTI.
Primary objective The primary objective is to evaluate the effect of oral supplementation with probiotic on the frequency of UTI during six months from start of intervention in adult women with recurrent UTI.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Willing and able to give informed consent for participation in the study.
- •Woman aged 18-50 years old at screening.
- •BMI ≥18 at screening.
- •Currently on antibiotic treatment for UTI, at the time of screening. Antibiotic treatment must stop within three days prior to first IP dose.
- •Recurrent UTI defined as at least two UTIs during the last six months or at least three UTIs during the last 12 months, according to information given by the subject.
- •Able and willing to comply with the restrictions defined for the the study period (see Section 10.6).
- •Access to Bank ID and ability to use the e-health platform (i.e. Internet access).
- •Ability to understand and comply with the requirements of the study, as judged by the Investigator.
排除标准
- •Postmenopausal (defined as 12 months of amenorrhoea).
- •Pregnant or breastfeeding.
- •Planning to become pregnant during the study.
- •Irregular menstruations combined with perimenopausal symptoms.
- •Known hypersensitivity or allergy to any of the components of the test product, or to the comparator (placebo).
- •Use of spermicide contraceptives including spermicidal condom within three days prior to first IP dose.
- •History of complicated cystitis, urgency incontinence, recent pyelonephritis, urological and/or gynaecologist abnormalities, immunocompromised, as judged by the Investigator.
- •Unstable bowel disorder such as diarrhoea, Crohn's disease, ulcerative colitis.
结局指标
主要结局
To Evaluate the Effect of Oral Supplementation With Lactobacillus Reuteri on the Frequency of Confirmed UTI in Adult Women With Recurrent UTI.
时间窗: 6 months
Mean number (Standard Deviation) of confirmed UTIs in adult women with recurrent UTI, during six months from start of intervention, as compared to placebo.
To Evaluate the Effect of Oral Supplementation With Lactobacillus Reuteri on the Frequency of Confirmed UTI in Adult Women With Recurrent UTI.
时间窗: 6 months
Mean number (Standard Deviation) of confirmed UTIs in adult women with recurrent UTI, during six months from start of intervention, as compared to placebo.
次要结局
- To Evaluate the Effect of Oral Supplementation With Lactobacillus Reuteri on the -Frequency of Confirmed UTI -Time to First Relapse of UTI. -Relapse Rate -Assess the Tolerability(6 month)
- To Evaluate the Effect of Oral Supplementation With Lactobacillus Reuteri on the -Frequency of Confirmed UTI -Time to First Relapse of UTI. -Relapse Rate -Assess the Tolerability(6 month)