Fecal Microbiota Transplantation for the Treatment of Recurrent Urinary Tract Infections

• ClinicalTrials.gov Identifier: NCT03050515
• Recruitment Status: Completed
• First Posted: February 13, 2017
• Last Update Posted: June 18, 2020
• Sponsor: University of California, Irvine
• Information provided by (Responsible Party): Felicia Lane, University of California, Irvine

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Recurrent Urinary Tract Infection	Biological: Fecal Microbiota Transplantation	Early Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Fecal Microbiota Transplantation for the Treatment of Recurrent Urinary Tract
• Actual Study Start Date: February 5, 2018
• Actual Primary Completion Date: June 30, 2019
• Actual Study Completion Date: February 23, 2020

Arms and Interventions

Arm

Intervention/treatment

Experimental: Fecal Transplant; Enrolled and screened patients will receive a donor directed fecal transplant via retention enema. This procedure will take place at the University of California Irvine Women's Health Center on the day of the participant's choosing. The day prior to the procedure, the participant will undergo a bowel prep and stop all prophylactic antibiotics. On the day of procedure, the patient will present to the clinic and undergo a simple, retention enema. This procedure takes about 30-40 minutes to complete and does not require any anesthesia or sedation.

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.; Other Names: FMT; Fecal Transplant

Outcome Measures

Primary Outcome Measures :

1. Change in frequency of culture proven urinary tract infections following fecal transplant [ Time Frame: 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.

Secondary Outcome Measures :

1. Efficacy of fecal transplant in transforming recurrent urinary tract infection bacteria profile to that of pan-sensitive organisms on urine culture specimens [ Time Frame: 6 months ]
   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.
2. Change in the gut microbiome following fecal transplantation measured via 16s sequencing of stool samples [ Time Frame: 6 months ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 100 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, California

UCI Women's Healthcare Center

Orange, California, United States, 92868

Sponsors and Collaborators

University of California, Irvine

Investigators

• Principal Investigator: Felicia Lane, MD; University of California, Irvine

More Information

• Responsible Party: Felicia Lane, Division Director of Female Pelvic Medicine and Reconstructive Medicine, University of California, Irvine
• ClinicalTrials.gov Identifier: NCT03050515
• Other Study ID Numbers: 2017-3541
• First Posted: February 13, 2017
• Last Update Posted: June 18, 2020
• Last Verified: June 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Infection; Urinary Tract Infections; Urologic Diseases