Fecal Microbiota Transplantation for the Treatment of Recurrent Urinary Tract
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change in frequency of culture proven urinary tract infections following fecal transplant
研究概览
简要总结
Recurrent urinary tract infections are quickly becoming a public health obstacle in our aging population. Almost 50% of women have at least one urinary tract infection in their lifetime; following this first infection, there is a 25-35% chance that she will have another infection in the subsequent 3-6 months. With each documented infection, a patient receives anywhere from a three to seven day course of antibiotics for treatment. Repeated courses of antibiotics often lead to the development of multi-drug resistant infections that are difficult to treat with our arsenal of oral medications. It is theorized that most, if not all, urinary tract infections are caused by bacteria from the gastrointestinal tract. If there is a generalized gut dysbiosis due to repeated courses of oral antibiotics, it will likely be difficult to ever adequately treat repeat urinary tract infections. This same theory led to the development and utilization of fecal microbiota transplantation in the treatment of refractory Clostridium difficile diarrhea. There are now several studies that have reported on the efficacy of fecal transplantation in the treatment of C.difficile infections as well as the correction of gut dysbiosis. Given this positive response in treatment of refractory infectious diarrhea, the investigators propose that the correction of gut dysbiosis can also treat refractory recurrent urinary tract infections. Therefore, the investigators propose this pilot study to determine the effectiveness of fecal transplantation in the treatment of refractory, recurrent urinary tract infections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •English speaking
- •Meet criteria for recurrent urinary tract infections A. Each infection with bacterial colony count of greater than 100,000 AND B. 2 culture proven urinary tract infections within the preceding 6 months or culture proven urinary tract infections within the preceding 12 months
- •Failed conservative management of recurrent urinary tract infections A. Completed 6-month trial of Macrobid, Trimethoprim or Methenamine suppression OR B. Completed 6-week series of intravesical instillations with DMSO or heparin/lidocaine
排除标准
- •Managed with a colostomy
- •Managed with a suprapubic catheter
- •Known renal abscess
- •Acute or chronic renal failure
- •Cardiac disease
- •Rectal prolapse or bleeding
- •Colon surgery in preceding 12 months
结局指标
主要结局
Change in frequency of culture proven urinary tract infections following fecal transplant
时间窗: 6 months
Recurrent urinary tract infections are defined as 2 or more urine culture proven urinary tract infections in 6 months or 3 or more culture proven urinary tract infections in 12 months. To assess complete treatment success following fecal transplant, the investigators will collect urine cultures 1 month, 3 months and 6 months after fecal transplantation, as well as with any symptoms of a urinary tract infection, to determine the frequency of culture proven urinary tract infections over a 6 month time period following fecal transplant.
次要结局
- Efficacy of fecal transplant in transforming recurrent urinary tract infection bacteria profile to that of pan-sensitive organisms on urine culture specimens(6 months)
- Change in the gut microbiome following fecal transplantation measured via 16s sequencing of stool samples(6 months)
研究者
Felicia Lane
Division Director of Female Pelvic Medicine and Reconstructive Medicine
University of California, Irvine