Randomized Controlled Trial of the Effect of Cranberry-lingonberry Juice on the Occurrence of Urinary Tract Infections, the Gut Microbiota, and the Uropathogenic Escherichia Coli
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- Change of the intestinal and urinary microbiome
研究概览
简要总结
Cranberry and cranberry-lingonberry juice prevented urinary tract infections in children and in adults in our earlier clinical trials. The preventive effect was, however, observed late in the follow-up and the next recurrence was not prevented in children. The investigators hypothesize that cranberry-lingonberry juice should be started already during the antimicrobial treatment of acute urinary tract infection in order to maximize the preventive efficacy of the juice. In addition, the investigators aim to find the explanation for the efficacy of cranberry-lingonberry juice by analyzing the concomitant changes in the chemical composition of urine and feces as well as the changes of gut microbiota.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recent confirmed urinary tract infection, diagnosed in Oulu University Hospital or Oulu Health Care Center
- •Age 1-16 years
排除标准
- •Continuous antimicrobial prophylaxis
- •Age < 12 months or > 16 years
- •Severe congenital kidney or other urinary tract anomaly in ultrasound
结局指标
主要结局
Change of the intestinal and urinary microbiome
时间窗: 3 months to 12 months
次要结局
- Time to the first recurrence(6 months)
- The occurrence of urinary tract infections (infection episodes/person years at risk)(12 months)
研究者
Terhi Tapiainen
Senior consultant in pediatric infectious diseases
University of Oulu