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Urinary Tract InfectionsPhase 1/2NCT07816913

WMT for Multidrug-Resistant Organism UTI

A Phase 1/2 study testing Washed Microbiota Transplantation (WMT) in people with Urinary Tract Infections and Recurrent Urinary Tract Infections, run by The Second Hospital of Nanjing Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Washed Microbiota Transplantation (WMT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteChina
Study dates
1 Aug 2022to 30 Jul 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

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

    Nanjing, Jiangsu, 210011

Other trials in China

About this study

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

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.

Read the detailed description

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.

Being tested
Washed Microbiota Transplantation (WMT)
Keywords
Washed microbiota transplantation, Fecal microbiota transplantation, Multidrug-resistant organism, Recurrent urinary tract infection
Medical subject headings
Urinary Tract Infections, Bacteriuria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT07816913
Study groupRoleWhat they receive
WMT Treatment GroupExperimentalNot described
Receives: Biological: Washed Microbiota Transplantation (WMT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 6 months

Secondary outcomes (16)

  1. Time to microbiological success

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

    Measured: Up to 6 months

  2. Number of UTI recurrence episodes

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

    Measured: Up to 6 and 12 months

  3. Baseline to day 7

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

    Measured: Up to 12 months

  4. 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).

    Measured: Baseline and 6 months

  5. 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.

    Measured: Baseline to day 7

  6. Change in hemoglobin

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

    Measured: Baseline to day 7

  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.

    Measured: Baseline to day 7

  8. 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.

    Measured: Baseline to day 7

  9. Change in urine nitrite

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

    Measured: Baseline to day 7

  10. 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.

    Measured: Baseline to day 7

  11. Change in procalcitonin (PCT)

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

    Measured: Baseline to day 7

  12. Change in alanine aminotransferase (ALT)

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

    Measured: Baseline to day 7

  13. Change in aspartate aminotransferase (AST)

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

    Measured: Baseline to day 7

  14. Change in total bilirubin

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

    Measured: Baseline to day 7

  15. Change in serum creatinine

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

    Measured: Baseline to day 7

  16. Change in blood urea nitrogen (BUN)

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

    Measured: Baseline to day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2026
  2. Study start1 Aug 2022
  3. Primary completion30 Jul 2024
  4. Study completion30 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07816913
Sponsor's protocol ID
WMT-MDRO-UTI-2022
Status last verified
Sep 2026
First submitted
30 May 2026
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Washed Microbiota Transplantation (WMT) in people with Urinary Tract Infections and Recurrent Urinary Tract Infections, run by The Second Hospital of Nanjing Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of microbiological success (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07816913.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.

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