NCT03050515

Fecal Microbiota Transplantation for the Treatment of Recurrent Urinary Tract Infections

Fecal Microbiota Transplantation for the Treatment of Recurrent Urinary Tract

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of California, Irvine · Academic / Other
• Sex: Female
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Recurrent Urinary Tract Infection

Interventions

Type	Name	Description
BIOLOGICAL	Fecal Microbiota Transplantation	This is a single arm study. All participants will receive a single fecal transplant to determine effectiveness in treating refractory recurrent urinary tract infections.

Timeline

• Start date: 2018-02-05
• Primary completion: 2019-06-30
• Completion: 2020-02-23
• First posted: 2017-02-13
• Last updated: 2020-06-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study