Preventing Urinary Tract Infections in Infants and Young Children With Probiotic E. Coli Nissle:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 530
- 试验地点
- 5
- 主要终点
- Recurrence of urinary tract infections
研究概览
简要总结
Urinary tract infections (UTIs) account for 5-14% of pediatric emergency department visits annually. At the moment, up to one third of children suffering of acute (UTI) will have a new infection and there is a lack of effective methods for preventing secondary UTIs in young children. Majority of UTIs in children are caused by intestinal bacteria of the patient, mainly E. coli that colonizes gut of the patient. E. coli Nissle is a probiotic strain that has been used successfully for treating acute gastrointestinal infections in children. The strain has also been proved to be safe for infants and young children. E. coli Nissle could be a potential solution for preventing recurrent urinary tract infections in children as it competes with pathogenic bacteria that usually cause UTIs in children.
The aim of this study is to evaluate efficacy of E. coli Nissle strain in secondary prevention of urinary tract infections in young children.
详细描述
In order to asses efficacy of E. coli Nissle strain in prevention of recurrent UTIs in children, we aim to conduct randomized, placebo controlled and double blinded clinical trial. We are going to recruit children who are suffering the first urinary tract infection of their life. The UTI will be treated by normal clinical recommendations decided by treating physician. Intervention will start on the day following the last day of the antimicrobial course.
The intervention will last for 15 days and the study participants will receive either intervention drug or placebo. Intervention drug contains 10 E8 CFU/ml of E. coli Nissle strain and will be administered as dose of 1 ml of oral suspension once daily for children aged under one year and twice daily for children aged more than one year.
The study patients will be monitored by monthly electronic surveys for six months after the intervention in order to measure proportion of the children who will have a new UTI during the follow up. We are also going to record possible adverse effects in both study groups. Also use of antimicrobial medication due to any reason will be recorded.
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)
盲法说明
The intervention drug or placebo will be given to participants in closed boxes without any labels. Appearance and dosing of the products will be similar. Investigators will not handle the boxes or study products.
入排标准
- 年龄范围
- — 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children who suffer of the first urinary tract infection of their life defined as pyuria, presence of symptoms (fever or focal symptom), no other explanation for infection, bacterial culture positive or culture result pending
- •Written informed consent
排除标准
- •Preterm birth, gestational age less than 35 weeks
- •Signs of life-threatening infection (such as meningitis)
- •Detected anomaly in urinary tract
- •Primary immunodeficiency
- •Detected anomaly of GE tract
- •Ongoing antimicrobial prophylaxis
- •Hospital-acquired infection
研究组 & 干预措施
Nissle group
Intervention will start on the day following the ending of the antimicrobial treatment of the UTI. Patients will receive 1 ml of oral suspension containing 10 E8 CFU/ml of E coli Nissle. Patients under one year of age will receive one daily dose and patients aged more than one year will receive a dose twice daily. Intervention will last for 30 days
干预措施: E. coli Nissle (Drug)
Control group
Intervention will start on the day following the ending of the antimicrobial treatment of the UTI. Patients will receive 1 ml of oral syrup consisting of Saccharum 630 mg/g and Aqua purificata 370 mg/g. Patients under one year of age will receive one daily dose and patients aged more than one year will receive a dose twice daily. Intervention will last for 30 days
干预措施: Placebo control (Other)
结局指标
主要结局
Recurrence of urinary tract infections
时间窗: Six months from study entry
Proportion of the study patient who will have at least one bacterial culture confirmed urinary tract infection
次要结局
- Stomach pain(Six months from study entry)
- Hospitalization day due to bacterial culture confirmed urinary tract infection(Six months from study entry)
- Number of urinary tract infections(Six months from study entry)
- Diarrhea(Six months from study entry)
- Antimicrobial treatment days for any indication(Six months, starting after the initial treatment at study entry has ended)
- Antimicrobial treatment days for suspected or confirmed urinary tract infection(Six months, starting after the initial treatment at study entry has ended)
研究者
Terhi Tapiainen
Adjunct Professor of Pediatrics
University of Oulu