Clinical trial NCT03050515: Fecal Microbiota Transplantation for the Treatment of Recurrent Urinary Tract Infections
Official title: Fecal Microbiota Transplantation for the Treatment of Recurrent Urinary Tract
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Recurrent Urinary Tract Infection
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2017-02-13
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in frequency of culture proven urinary tract infections following fecal transplant
timeFrame: 6 months
Secondary outcomes:
measure: Efficacy of fecal transplant in transforming recurrent urinary tract infection bacteria profile to that of pan-sensitive organisms on urine culture specimens
timeFrame: 6 months
measure: Change in the gut microbiome following fecal transplantation measured via 16s sequencing of stool samples
timeFrame: 6 months
Other outcomes:
Locations:
city: Orange
country: United States
facility: UCI Women's Healthcare Center
state: California
Study officials:
affiliation: University of California, Irvine
name: Felicia Lane, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jeney SES, Avelar-Barragan J, Whiteson K, Chang J, Dutta S, Lane F. Fecal Putative Uropathogen Abundance and Antibiotic Resistance Gene Carriage in Women With Refractory Recurrent Urinary Tract Infection Treated With Fecal Microbiota Transplantation. Female Pelvic Med Reconstr Surg. 2022 Apr 1;28(4):213-219. doi: 10.1097/SPV.0000000000001090. Epub 2021 Oct 1.