Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WMT Treatment Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Microbiota Medicine & Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu | 210011 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
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 |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |