NCT07816913

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2022

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2026

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 14, 2026

Completed
Last Updated

September 14, 2026

Status Verified

September 1, 2026

Enrollment Period

2 years

First QC Date

May 30, 2026

Last Update Submit

September 11, 2026

Conditions

Urinary Tract InfectionsMultidrug-Resistant Bacterial InfectionsBacteriuriaRecurrent Urinary Tract Infections

Keywords

Washed microbiota transplantationFecal microbiota transplantationMultidrug-resistant organismRecurrent urinary tract infection

Outcome Measures

Primary Outcomes (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.

    Up to 6 months

Secondary Outcomes (16)

  • Time to microbiological success

    Up to 6 months

  • Number of UTI recurrence episodes

    Up to 6 and 12 months

  • Baseline to day 7

    Up to 12 months

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

    Baseline and 6 months

  • Change in white blood cell count

    Baseline to day 7

  • +11 more secondary outcomes

Study Arms (1)

WMT Treatment Group

EXPERIMENTAL
Biological: Washed Microbiota Transplantation (WMT)

Interventions

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.

WMT Treatment Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Nanjing, Jiangsu, 210011, China

Location

MeSH Terms

Conditions

Urinary Tract InfectionsBacteriuria

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Gastroenterology

Study Record Dates

First Submitted

May 30, 2026

First Posted

September 14, 2026

Study Start

August 1, 2022

Primary Completion

July 30, 2024

Study Completion

July 30, 2024

Last Updated

September 14, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)