Recurrent Urinary Tract Infections, Urinary Tract Infections
Conditions
Keywords
Washed microbiota transplantation, Fecal microbiota transplantation, Recurrent urinary tract infection
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.
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.
Interventions
BIOLOGICALWashed 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
The Second Hospital of Nanjing Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of UTI recurrence episodes within 12 months post-WMT | 12 month | Total number of symptomatic UTI episodes during the 12-month follow-up period after the first WMT session. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of UTI recurrence episodes within 6 months post-WMT | 6 months | Total number of symptomatic UTI episodes during the 6-month follow-up period. |
| Clinical manifestations during acute episodes | Up to 12 months | Clinical symptoms (dysuria, frequency, urgency, hematuria, etc.) and antibiotic usage during acute UTI episodes in the follow-up period. |
| Urine routine and culture during acute episodes | Up to 12 months | Urine leukocyte count, bacterial count, leukocyte esterase, nitrite test, and clean-catch midstream urine culture with colony count during acute UTI episodes. |
| Incidence of adverse events | Up to 12 months | Incidence, severity, and causality of adverse events related to WMT procedure (e.g., abdominal discomfort, diarrhea, fever) and during follow-up. |
| Efficacy assessment rate | 12 months | 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. |
Countries
China
Outcome results
None listed