WMT for Recurrent Urinary Tract Infections (WMT-rUTI)

A Prospective, Single-Center, Single-Arm Clinical Study of Washed Microbiota Transplantation for Recurrent Urinary Tract Infections

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.

Study Overview

• Status: Completed
• Conditions: Urinary Tract Infections; Recurrent Urinary Tract Infections
• Intervention / Treatment: Biological: Washed Microbiota Transplantation (WMT)

Detailed Description

This study evaluates WMT as an interventional treatment for rUTI. WMT preparation follows the Nanjing Consensus on Washed Microbiota Transplantation (Chin Med J, 2020). Donor stool is obtained from healthy screened donors and processed using the GenFMTer intelligent fecal microbiota separation system with repeated washing and strict quality control.

Patients will receive WMT via mid-gut TET or colonic TET for 2-3 sessions. Clinical assessments include UTI episode frequency, symptom severity, antibiotic usage, and adverse events. Microbiological assessments include urine routine and clean-catch midstream urine culture during acute episodes. Fecal and urine samples will be collected at baseline (before TET placement), 3 months, and 6 months post-WMT for 16S rRNA gene high-throughput sequencing to analyze gut and urinary microbiota composition, alpha/beta diversity, and donor colonization via SourceTracker.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210011
      • Department of Microbiota Medicine & Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: WMT Treatment Group

Biological: Washed Microbiota Transplantation (WMT); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of UTI recurrence episodes within 6 months post-WMT	Total number of symptomatic UTI episodes during the 6-month follow-up period.	6 months
Clinical manifestations during acute episodes	Clinical symptoms (dysuria, frequency, urgency, hematuria, etc.) and antibiotic usage during acute UTI episodes in the follow-up period.	Up to 12 months
Urine routine and culture during acute episodes	Urine leukocyte count, bacterial count, leukocyte esterase, nitrite test, and clean-catch midstream urine culture with colony count during acute UTI episodes.	Up to 12 months
Incidence of adverse events	Incidence, severity, and causality of adverse events related to WMT procedure (e.g., abdominal discomfort, diarrhea, fever) and during follow-up.	Up to 12 months
Efficacy assessment rate	Effective: ≤2 UTI episodes within 12 months post-WMT or ≥50% reduction compared to baseline. Ineffective: ≥3 episodes and <50% reduction. Overall effective rate = (effective cases / total cases) × 100%. Subgroups include simple rUTI, complicated rUTI, premenopausal, postmenopausal, catheter-related, type 2 diabetes with rUTI, and upper urinary tract stone with rUTI.	12 months

Collaborators and Investigators

• Sponsor: The Second Hospital of Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): August 30, 2024
• Study Completion (Actual): August 30, 2024

Study Registration Dates

• First Submitted: May 30, 2026
• First Submitted That Met QC Criteria: May 30, 2026
• First Posted (Actual): June 4, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: May 30, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Washed microbiota transplantation; Fecal microbiota transplantation; Recurrent urinary tract infection
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Infections; Urinary Tract Infections
• Other Study ID Numbers: WMT-rUTI-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No