WMT for Recurrent Urinary Tract Infections

NCT07627412 | Completed Phase 1 DMC

• 1 other identifier: WMT-rUTI-2022
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

his is a single-center, prospective, single-arm, interventional clinical study to evaluate the clinical efficacy, safety, and potential mechanisms of washed microbiota transplantation (WMT) in patients with recurrent urinary tract infections (rUTI). Recurrent UTI is defined as ≥2 episodes within 6 months or ≥3 episodes within 1 year. Traditional management relies heavily on antibiotics, which often lead to gut dysbiosis and increased infection risk. WMT may reconstruct intestinal microbiota, restore colonization resistance, and modulate immunity through the gut-bladder axis. Approximately 30 eligible patients will receive WMT via mid-gut or colonic transendoscopic enteral tubing (TET) for 2-3 times according to the Nanjing Consensus on Washed Microbiota Transplantation. Participants will be followed for 12 months.

Conditions

Urinary Tract Infections; Recurrent Urinary Tract Infections

Keywords

Washed microbiota transplantation; Fecal microbiota transplantation; Recurrent urinary tract infection

Outcome Measures

Primary Outcomes (1)

• Number of UTI recurrence episodes within 12 months post-WMT

  Total number of symptomatic UTI episodes during the 12-month follow-up period after the first WMT session.

  12 month

Secondary Outcomes (5)

• Number of UTI recurrence episodes within 6 months post-WMT

  6 months

• Clinical manifestations during acute episodes

  Up to 12 months

• Urine routine and culture during acute episodes

  Up to 12 months

• Incidence of adverse events

  Up to 12 months

• Efficacy assessment rate

  12 months

Study Arms (1)

WMT Treatment Group

EXPERIMENTAL

Biological: Washed Microbiota Transplantation (WMT)

Interventions

Washed Microbiota Transplantation (WMT) BIOLOGICAL

Participants will receive washed microbiota transplantation delivered via mid-gut transendoscopic enteral tubing (TET) or colonic TET for 2-3 times. The WMT preparation follows the Nanjing Consensus on Washed Microbiota Transplantation (Chin Med J, 2020). Donor fecal material is obtained from healthy screened donors and processed using the GenFMTer intelligent separation system with repeated washing and quality control. The final microbiota suspension is transplanted into the mid-gut or colon through an indwelling TET tube.

WMT Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years, both sexes.
• Meeting the diagnostic criteria for recurrent urinary tract infection: ≥2 symptomatic UTI episodes within 6 months or ≥3 episodes within 1 year.
• Planning to receive washed microbiota transplantation (WMT) treatment.
• Able to provide informed consent and comply with scheduled follow-up visits, examinations, and specimen collection.

You may not qualify if:

• Received antimicrobial therapy within 48 hours before WMT.
• Complicated UTI requiring surgical intervention, including urinary tract tumor, stricture, congenital malformation, or neurogenic bladder.
• Co-infection with other urogenital pathogens including fungi, viruses, Mycoplasma, or Chlamydia.
• Unable to tolerate gastroscopy or colonoscopy for TET tube placement.
• Severe comorbidities involving heart, liver, kidney, hematopoietic system, respiratory system, or endocrine system that may affect survival, or other serious diseases affecting survival.
• Pregnant or lactating women.
• Coexisting psychiatric disorders.
• Other conditions deemed unsuitable for enrollment by the investigator.

Sponsors & Collaborators

• The Second Hospital of Nanjing Medical University: lead

Study Sites (1)

Department of Microbiota Medicine & Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210011, China

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Gastroenterology

Study Record Dates

• First Submitted: May 30, 2026
• First Posted: June 4, 2026
• Study Start: August 1, 2022
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)