Fecal Microbiota Transplantation for the Treatment of Recurrent Urinary Tract Infections

Completed · Early Phase 1

Conditions studied: Recurrent Urinary Tract Infection

In brief

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.

Key facts

Study ID

NCT03050515

Run by

University of California, Irvine

People needed

12

Starts

2018-02-05

Expected to finish

2020-02-23

Last updated by the study team

2020-06-18

Who can join

Age: 18 and older, up to 100. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• Pregnant
• 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

Where it is running

• UCI Women's Healthcare Center — Orange, California, United States

Full record on ClinicalTrials.gov

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