Probiotic and Effects on Multi-Drug Resistant Urinary Tract Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change in Resistance Pattern
研究概览
简要总结
This pilot study is a single-site randomized, double blinded placebo-controlled in females with recurrent multi-drug resistant (MDR) urinary tract infections(UTI). Our study hypothesizes that a novel probiotic strain improves antibiotic sensitivity patterns in these former MDR UTIs.
详细描述
The aims of this study are (1) to evaluate the effects of six months of probiotic therapy in addition to standard of care in changing sensitivity patterns of MDR bacteria causing recurrent UTI, (2) analyze the genetic composition of MDR bacterial isolates causing recurrent UTI before and after administration of probiotic vs. placebo, with standard of care antibiotics.
Study subjects will be asked to take a either a probiotic supplement or placebo at a dose of 1 caplet per day for 24 weeks in addition to antibiotic regimen. Subjects will be followed for 12 months. The outcome measure is the percent of probiotic ingestors vs placebo ingestors who experience a change in antibiotic susceptibility over this time period. The secondary outcome measure is the evaluation of genetic composition of bacteria recurring after probiotic vs. placebo administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female, age 18-90
- •Ability to void spontaneously
- •Suffers from recurrent multi-drug resistant or extensively drug resistant urinary tract infections caused by E.coli, Klebsiella, Enterococcus, Citrobacter, Proteus, Enterobacter, Serratia and Providencia.
排除标准
- •Has staghorn renal calculi, chronic hydronephrosis, intermittent catherization, indwelling urinary catheters, urinary diversions, end stage renal disease on hemodialysis, transplantation, HIV, cirrhosis, pancreatitis, allergy to soy or milk/milk proteins or lactose intolerance
- •Pregnant or breastfeeding
- •Currently taking probiotics. 4 week washout.
研究组 & 干预措施
Probiotic + Antibiotic
50 subjects to receive probiotic supplement once daily for 6 months in capsule form, in addition to standard antibiotic regimen for treatment of UTI.
干预措施: Bifidobacterium infantis (Dietary Supplement)
Probiotic + Antibiotic
50 subjects to receive probiotic supplement once daily for 6 months in capsule form, in addition to standard antibiotic regimen for treatment of UTI.
干预措施: Antibiotics (Drug)
Placebo + Antibiotic
50 subjects to receive placebo once daily for 6 months in capsule form, in addition to antibiotic regimen for treatment of UTI.
干预措施: Placebo (Other)
Placebo + Antibiotic
50 subjects to receive placebo once daily for 6 months in capsule form, in addition to antibiotic regimen for treatment of UTI.
干预措施: Antibiotics (Drug)
结局指标
主要结局
Change in Resistance Pattern
时间窗: 6-8 weeks after initial dose
The change in the quantity of antibiotics reported to be resistant per organism per culture per patient.
Bacterial isolate genomic characteristics
时间窗: 12 months after initial dose
genomic sequencing of bacterial isolates to determine genetic identity
次要结局
- Sensitivity pattern post-probiotic therapy(12 months after initial dose)
- UTI reduction(12 months after initial dose)
- Antibiotics Quantity(12 months after initial dose)
- Healthcare visit(12 months after initial dose)
- Length of time for change in resistance(12 months after initial dose)