WMT for Recurrent Urinary Tract Infections
NCT07627412 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2026-06-04
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
- Recurrent Urinary Tract Infections
- Urinary Tract Infections
Interventions
- 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.
Sponsors & Collaborators
-
The Second Hospital of Nanjing Medical University
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-08-01
- Primary Completion
- 2024-08-30
- Completion
- 2024-08-30
Countries
- China
Study Locations
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