Fecal Microbiota Transplantation for the Treatment of Recurrent Urinary Tract Infections

Recurrent Urinary Tract Infection Clinical Trial

Official title:

Fecal Microbiota Transplantation for the Treatment of Recurrent Urinary Tract

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03050515
• Other study ID #: 2017-3541
• Status: Completed
• Phase: Early Phase 1
• Start date: February 5, 2018
• Est. completion date: February 23, 2020

Study information

• Verified date: June 2020
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 23, 2020
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Infection
• Recurrent Urinary Tract Infection
• Urinary Tract Infections

Intervention

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.

Locations

Country	Name	City	State
United States	UCI Women's Healthcare Center	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in frequency of culture proven urinary tract infections following fecal transplant	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.	6 months
Secondary	Efficacy of fecal transplant in transforming recurrent urinary tract infection bacteria profile to that of pan-sensitive organisms on urine culture specimens	Often, patients with refractory recurrent urinary tract infection become infected with bacteria that are multi-drug resistant and therefore difficult to treat. To assess if a fecal transplant can alter the bacterial antibiotic susceptibility profile, the investigators will evaluate urine cultures 1 month, 3 months and 6 months after fecal transplant to test for infection and then to assess the antibiotic resistance profile.	6 months
Secondary	Change in the gut microbiome following fecal transplantation measured via 16s sequencing of stool samples	The gut microbiome is an evolving field of research, especially following a fecal transplant. The investigators will collect a stool sample prior to fecal transplant and then at regular intervals following fecal transplant (1 day, 1 week, 1 month, 3 months and 6 months post-transplantation) to determine how a patient's gut microbiomes (via 16s sequencing) is affected by fecal transplantation.	6 months