跳至主要内容
临床试验/NCT01696227
NCT01696227已完成不适用

Targeted Pathogen Replacement With Novel Probiotic Treatment for Prevention of Recurrent UTIs in Children

Nationwide Children's Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2012年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Ability of Nissle 1917 to adversely affect the growth in vitro of identified uropathogens

研究概览

简要总结

Background:

Urinary tract infections (UTIs) are a common and costly cause of doctor visits for children. Frequent UTIs trigger kidney damage that leads to serious diseases like high blood pressure, pregnancy complications, and kidney failure. Treating UTIs with preventative antibiotics has not shown improvement of the risk of these diseases, and contributes to the growing public health issue of antibiotic resistant bacteria. Bacteria that cause UTIs originate from the bowel. In an effort to reduce the number of UTIs, investigators want to exchange the bacteria living in our bowels for a more harmless variety.

Hypothesis and specific aims:

Investigators hypothesize a probiotic comprised of a probiotic bacteria will change the bowel bacteria, thereby reducing the numbers of infection-causing bacteria, thus reducing frequency of UTIs in healthy patients with recurrent UTIs and those patients with urinary tract problems that require use of catheters to empty their bladders.

Aim 1: Investigators plan to challenge infection-causing bacteria like Pseudomonas species, Enterococcus species, and Klebsiella species to live in the same environment with the probiotic bacteria to see how the numbers of each bacteria change.

Aim 2: Investigators will culture bacteria that live on urinary catheters and then challenge them to live in the same environment as the probiotic bacteria.

Potential Impact:

This novel treatment prevents UTIs by exchanging a patient's bowel bacteria for a harmless bacteria and reduces the use of antibiotics overall in the community.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with urinary catheters placed that will be getting them removed

排除标准

  • Patient's currently getting treated for UTI

研究组 & 干预措施

Nissle 1917

In vitro, Nissle 1917's ability to adversely affect the growth of uropathogens associated with urinary catheters and those with a known GI resevoir will be measured.

干预措施: Nissle 1917 (Drug)

结局指标

主要结局

Ability of Nissle 1917 to adversely affect the growth in vitro of identified uropathogens

时间窗: 2 years

Uropathogens obtained from discarded clinical samples will be challenged to live in the same environment as the probiotic, Nissle 1917. Colonies of uropathogens and Nissle 1917 will be counted as a measure of the more successful organism as well as, zone of inhibition will be measured in co-cultures.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elizabeth Lucas

Fellow MD

Nationwide Children's Hospital

研究点 (1)

Loading locations...

相似试验

Novel Probiotic Treatment for Prevention of... | 临床试验