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Completed

NCT Number: NCT07816913

WMT for Multidrug-Resistant Organism UTI

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.

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Key information

Conditions

Urinary Tract Infections Bacteriuria Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Multidrug-Resistant Bacterial Infections Recurrent Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Department of Microbiota Medicine & Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210011, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years, both sexes.
  • Recurrent UTI (symptomatic UTI or asymptomatic bacteriuria), with ≥2 episodes in the past 6 months or ≥3 episodes in the past year.
  • Clean-catch midstream urine culture at enrollment showing bacterial colony count ≥10^5 CFU/ml, with multidrug-resistant organism (non-susceptible to ≥3 antimicrobial categories, including resistant and intermediate).
  • Physically eligible and willing to receive colonic TET tube placement and WMT treatment.
  • Able to provide informed consent and comply with scheduled follow-up visits and specimen collection.

Exclusion criteria

  • Received effective antimicrobial therapy within 48 hours before WMT.
  • Unable to tolerate colonoscopy or TET tube placement.
  • Severe comorbidities with expected survival less than 6 months.
  • Pregnant or lactating women.
  • Other conditions deemed unsuitable for enrollment by the investigator.

Treatment and study plan

Washed Microbiota Transplantation (WMT)

Biological

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.

Primary outcomes

  1. Rate of microbiological success

    Time frame: Up to 6 months

    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.

Secondary outcomes

  1. Time to microbiological success

    Time frame: Up to 6 months

    Time from the first WMT to the first of two consecutive negative urine cultures for the baseline pathogen.

  2. Number of UTI recurrence episodes

    Time frame: Up to 6 and 12 months

    Number of symptomatic UTI episodes during the follow-up period.

  3. Baseline to day 7

    Time frame: Up to 12 months

    Clinical manifestations of acute UTI episodes and antibiotic usage during follow-up.

  4. Quality of life score measured by the 36-Item Short Form Health Survey (SF-36)

    Time frame: Baseline and 6 months

    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).

  5. Change in white blood cell count

    Time frame: Baseline to day 7

    Change in peripheral blood white blood cell count, expressed as ×10^9/L, from baseline to days 4 and 7 post-WMT.

  6. Change in hemoglobin

    Time frame: Baseline to day 7

    Change in peripheral blood hemoglobin, expressed as g/L, from baseline to days 4 and 7 post-WMT.

  7. Change in platelet count

    Time frame: Baseline to day 7

    Change in peripheral blood platelet count, expressed as ×10^9/L, from baseline to days 4 and 7 post-WMT.

  8. Change in urine white blood cell count

    Time frame: Baseline to day 7

    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.

  9. Change in urine nitrite

    Time frame: Baseline to day 7

    Change in urine nitrite on dipstick, expressed as positive or negative, from baseline to days 4 and 7 post-WMT.

  10. Change in C-reactive protein (CRP)

    Time frame: Baseline to day 7

    Change in serum C-reactive protein, expressed as mg/L, from baseline to days 4 and 7 post-WMT.

  11. Change in procalcitonin (PCT)

    Time frame: Baseline to day 7

    Change in serum procalcitonin, expressed as ng/mL, from baseline to days 4 and 7 post-WMT.

  12. Change in alanine aminotransferase (ALT)

    Time frame: Baseline to day 7

    Change in serum alanine aminotransferase, expressed as U/L, from baseline to days 4 and 7 post-WMT.

  13. Change in aspartate aminotransferase (AST)

    Time frame: Baseline to day 7

    Change in serum aspartate aminotransferase, expressed as U/L, from baseline to days 4 and 7 post-WMT.

  14. Change in total bilirubin

    Time frame: Baseline to day 7

    Change in serum total bilirubin, expressed as µmol/L, from baseline to days 4 and 7 post-WMT.

  15. Change in serum creatinine

    Time frame: Baseline to day 7

    Change in serum creatinine, expressed as µmol/L, from baseline to days 4 and 7 post-WMT.

  16. Change in blood urea nitrogen (BUN)

    Time frame: Baseline to day 7

    Change in blood urea nitrogen, expressed as mmol/L, from baseline to days 4 and 7 post-WMT.

Sponsors and collaborators

Lead sponsor

The Second Hospital of Nanjing Medical University

Other

Registry information

Official study title

A Prospective, Single-Center, Single-Arm Clinical Study of Washed Microbiota Transplantation for Multidrug-Resistant Organism Urinary Tract Infection

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 14, 2026
Registry last updated
Sep 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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