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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
Department of Microbiota Medicine & Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
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.
Time frame: 12 month
Number of UTI recurrence episodes within 6 months post-WMT
Total number of symptomatic UTI episodes during the 6-month follow-up period.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
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