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WMT for Recurrent Urinary Tract Infections (WMT-rUTI)

30. maj 2026 opdateret af: Faming Zhang, The Second Hospital of Nanjing Medical University

A Prospective, Single-Center, Single-Arm Clinical Study of Washed Microbiota Transplantation for Recurrent Urinary Tract Infections

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

30

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
    • Jiangsu
      • Nanjing, Jiangsu, Kina, 210011
        • Department of Microbiota Medicine & Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: WMT Treatment Group
Biologisk: Washed 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of UTI recurrence episodes within 12 months post-WMT
Tidsramme: 12 month
Total number of symptomatic UTI episodes during the 12-month follow-up period after the first WMT session.
12 month

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of UTI recurrence episodes within 6 months post-WMT
Tidsramme: 6 months
Total number of symptomatic UTI episodes during the 6-month follow-up period.
6 months
Clinical manifestations during acute episodes
Tidsramme: Up to 12 months
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
Tidsramme: 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.
Up to 12 months
Incidence of adverse events
Tidsramme: 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.
Up to 12 months
Efficacy assessment rate
Tidsramme: 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.
12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

The Second Hospital of Nanjing Medical University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. august 2022

Primær færdiggørelse (Faktiske)

30. august 2024

Studieafslutning (Faktiske)

30. august 2024

Datoer for studieregistrering

Først indsendt

30. maj 2026

Først indsendt, der opfyldte QC-kriterier

30. maj 2026

Først opslået (Faktiske)

4. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • WMT-rUTI-2022

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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Kliniske forsøg med Urinvejsinfektioner

Kliniske forsøg med Washed Microbiota Transplantation (WMT)

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