Fecal Microbiota Transplantation for the Treatment of Recurrent Urinary Tract Infections

NCT ID: NCT03050515

Last Updated: 2020-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-05
• Study Completion Date: 2020-02-23

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.

Conditions

Recurrent Urinary Tract Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type: BIOLOGICAL

This is a single arm study. All participants will receive a single fecal transplant to determine effectiveness in treating refractory recurrent urinary tract infections.

Interventions

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

FMT; Fecal Transplant

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Felicia Lane

Division Director of Female Pelvic Medicine and Reconstructive Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Felicia Lane, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

UCI Women's Healthcare Center

Orange, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34608030 (View on PubMed)

Other Identifiers

2017-3541

Identifier Type: -

Identifier Source: org_study_id