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Fecal Microbiota Transplantation for the Treatment of Recurrent Urinary Tract Infections

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ClinicalTrials.gov Identifier: NCT03050515
Recruitment Status : Active, not recruiting
First Posted : February 13, 2017
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
Felicia Lane, University of California, Irvine

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
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
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


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




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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03050515


Locations
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United States, California
UCI Women's Healthcare Center
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Investigators
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Principal Investigator: Felicia Lane, MD University of California, Irvine

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Responsible Party: Felicia Lane, Division Director of Female Pelvic Medicine and Reconstructive Medicine, University of California, Irvine
ClinicalTrials.gov Identifier: NCT03050515     History of Changes
Other Study ID Numbers: 2017-3541
First Posted: February 13, 2017    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Infection
Urinary Tract Infections
Urologic Diseases