Effectiveness of Prophylaxis of Urinary Tract Infections in Children With a Probiotic Containing Lactobacillus Rhamnosus PL1 and Lactobacillus Plantarum PM1, a Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- frequencies of recurrence of UTI
研究概览
简要总结
The investigators aim to assess the effectiveness of prophylaxis of urinary tract infections in children with a probiotic containing Lactobacillus rhamnosus PL1 and Lactobacillus plantarum PM1. It is formulated a hypothesis that a 3-months course of probiotic prophylasis is more effective than placebo.
详细描述
In previously published European and global guidelines, there has been no consensus among experts regarding the prophylaxis of recurrence urinary tract infections. Depending on the recommendation, the prevention of recurrence UTI should be used, not justified, or should be used in special cases. However, preparations that will be effective in preventing UTI and will not cause bacterial resistance are still sought.
106 patients aged 3 to 18 years with recurrence UTIs (defined as: ≥2 infections in the upper urinary tract or 1 UTI in the upper urinary tract and ≥1 in the lower urinary tract or ≥3 or more UTI in the lower urinary tract in one year) or children with ≥1 infection in the upper urinary tract and ≥1 of recurrent UTIs risk factors (congenital anomalies of the kidney and urinary tract, constipation, bladder dysfunction, myelomeningocele, sexual activity in girls) will be randomly assigned to receive a 90-days prophylaxsis arm (probiotic UroLact containing Lactobacillus Rhamnosus PL1 and Lactobacillus Plantarum PM1) or a 90-days placebo arms.
The primary outcome measure will be frequencies of recurrence of UTI during the 6 months after the intervention.
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
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •recurrent UTIs (defined as: ≥2 infections in the upper urinary tract or 1 UTI in the upper urinary tract and ≥1 in the lower urinary tract or ≥3 or more UTI in the lower urinary tract in one year) OR 1 infection in the upper urinary tract and ≥1 of recurrent UTIs risk factors: congenital anomalies of the kidney and urinary tract, constipation, bladder dysfunction, myelomeningocele, sexual activity in girls
- •≥1 episode of urinary tract infection in the last 6 months
排除标准
- •intake of probiotic preparations for ≥1 month in the last 3 months
- •known allergy to the study products
- •immunosuppression therapy
- •disease with immune deficiency
- •children with other coexisting infection, e.g. meningitis, sepsis, pneumonia, otitis
研究组 & 干预措施
Placebo supply for 90 days
Patients will receive placebo (in blinded sachets)
干预措施: Placebo control group (Other)
Probiotic supply for 90 days
Patients will receive probiotics containing Lactobacillus rhamnosus PL1 and Lactobacillus plantarum PM1 (in blinded sachets).
干预措施: Probiotic experimental group (Dietary Supplement)
结局指标
主要结局
frequencies of recurrence of UTI
时间窗: 6 months after intervention
New onset of symptomatic UTI within the 6 months follow-up period.
次要结局
- frequencies of hospitalization due to UTI(6 months after intervention)
- the number of days of antibiotic therapy due to UTI(6 months after intervention)