A Phase 1/2 interventional study of Washed Microbiota Transplantation (WMT) in Urinary Tract Infections, Recurrent Urinary Tract Infections and Multidrug-Resistant Bacterial Infections, sponsored by The Second Hospital of Nanjing Medical University. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by The Second Hospital of Nanjing Medical University · Phase 1/2, Interventional, and Treatment
This is a single-center, prospective, single-arm, exploratory clinical study to evaluate the efficacy, safety, and potential mechanisms of washed microbiota transplantation (WMT) in patients with recurrent urinary tract infections caused by multidrug-resistant organisms (MDRO-UTI). With increasing antimicrobial resistance, MDRO UTI becomes refractory and poses a significant therapeutic challenge. WMT may reconstruct gut microbiota, reduce uropathogen colonization, decrease antibiotic resistance gene burden, and modulate host immunity and metabolism. Approximately 10 eligible patients will receive WMT delivered via colonic transendoscopic enteral tubing (TET) for 3 times according to the Nanjing Consensus on Washed Microbiota Transplantation. Participants will be followed for up to 12 months with clinical, microbiological, metagenomic, metabolomic, and immunological assessments.
This study aims to assess whether WMT can achieve microbiological eradication of baseline MDRO pathogens and reduce UTI recurrence. Donor stool will be obtained from healthy screened donors and processed using the GenFMTer intelligent fecal microbiota separation system with strict quality control and washing procedures. Patients will receive WMT via colonic TET for 3 sessions.
Assessments include: (1) Microbiological: clean-catch midstream urine culture and antimicrobial susceptibility testing at baseline, days 4 and 7, and months 1, 3, 6, and during acute episodes; (2) Laboratory: blood routine, urine routine, CRP, procalcitonin, liver and kidney function at baseline and days 4 and 7; (3) Quality of life: SF-36 questionnaire at baseline and month 6; (4) Safety: adverse events throughout follow-up; (5) Multi-omics: fecal and urine metagenomic sequencing (alpha/beta diversity, taxonomic composition, SourceTracker colonization analysis, StrainGE strain tracking, antibiotic resistance genes, and UPEC virulence genes including FimH, PapG, CsgBAC, BarA, UvrY); serum/urine LC-MS metabolomics (untargeted and targeted); serum cytokines by ELISA (IL-6, IL-10, IL-22, IFN, GM-CSF, Eotaxin-1/CCL11); lymphocyte subsets and CD4/CD8 by flow cytometry; urinary secretory IgA by radioimmunoassay. Bioinformatic analyses including LefSe, ROC curves, and OPLS-DA will be used for integrative analysis.
51 studies on the registry are indexed under Bacteriuria; 3 are open to participants now.
This study's enrollment of 10 is below the median of 100 across 37 interventional studies indexed under Bacteriuria.
Browse Bacteriuria studies →The Second Hospital of Nanjing Medical University is the lead sponsor of 70 studies on the registry; 36 are open to participants now.
Compared within Bacteriuria, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Urinary Tract Infections. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biological: Washed Microbiota Transplantation (WMT)
Participants will receive washed microbiota transplantation delivered via colonic transendoscopic enteral tubing (TET) for 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 colon through an indwelling TET tube.
Rate of microbiological success
Microbiological success is defined as two consecutive negative clean-catch midstream urine cultures for the baseline pathogen during the follow-up period. Microbiological failure is defined as growth of the baseline pathogen at ≥10\^5 CFU/ml at the last follow-up urine culture.
Time frame: Up to 6 months
Time to microbiological success
Time from the first WMT to the first of two consecutive negative urine cultures for the baseline pathogen.
Time frame: Up to 6 months
Number of UTI recurrence episodes
Number of symptomatic UTI episodes during the follow-up period.
Time frame: Up to 6 and 12 months
Baseline to day 7
Clinical manifestations of acute UTI episodes and antibiotic usage during follow-up.
Time frame: Up to 12 months
Quality of life score measured by the 36-Item Short Form Health Survey (SF-36)
Changes in quality of life scores measured by the 36-Item Short Form Health Survey (SF-36) from baseline to 6 months post-WMT. The SF-36 consists of eight subscales: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each subscale is scored from 0 to 100, with higher scores indicating a better outcome (better health-related quality of life).
Time frame: Baseline and 6 months
Change in white blood cell count
Change in peripheral blood white blood cell count, expressed as ×10\^9/L, from baseline to days 4 and 7 post-WMT.
Time frame: Baseline to day 7
Change in hemoglobin
Change in peripheral blood hemoglobin, expressed as g/L, from baseline to days 4 and 7 post-WMT.
Time frame: Baseline to day 7
Change in platelet count
Change in peripheral blood platelet count, expressed as ×10\^9/L, from baseline to days 4 and 7 post-WMT.
Time frame: Baseline to day 7
Change in urine white blood cell count
Change in urine white blood cell count on microscopy, expressed as cells per high-power field, from baseline to days 4 and 7 post-WMT.
Time frame: Baseline to day 7
Change in urine nitrite
Change in urine nitrite on dipstick, expressed as positive or negative, from baseline to days 4 and 7 post-WMT.
Time frame: Baseline to day 7
Change in C-reactive protein (CRP)
Change in serum C-reactive protein, expressed as mg/L, from baseline to days 4 and 7 post-WMT.
Time frame: Baseline to day 7
Change in procalcitonin (PCT)
Change in serum procalcitonin, expressed as ng/mL, from baseline to days 4 and 7 post-WMT.
Time frame: Baseline to day 7
Change in alanine aminotransferase (ALT)
Change in serum alanine aminotransferase, expressed as U/L, from baseline to days 4 and 7 post-WMT.
Time frame: Baseline to day 7
Change in aspartate aminotransferase (AST)
Change in serum aspartate aminotransferase, expressed as U/L, from baseline to days 4 and 7 post-WMT.
Time frame: Baseline to day 7
Change in total bilirubin
Change in serum total bilirubin, expressed as µmol/L, from baseline to days 4 and 7 post-WMT.
Time frame: Baseline to day 7
Change in serum creatinine
Change in serum creatinine, expressed as µmol/L, from baseline to days 4 and 7 post-WMT.
Time frame: Baseline to day 7
Change in blood urea nitrogen (BUN)
Change in blood urea nitrogen, expressed as mmol/L, from baseline to days 4 and 7 post-WMT.
Time frame: Baseline to day 7
Plan to share: No
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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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The Second Hospital of Nanjing Medical University