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Completed
NCT07816913
WMT for Multidrug-Resistant Organism UTI
Conditions: Urinary Tract Infections, Recurrent Urinary Tract Infections, Multidrug-Resistant Bacterial Infections, Bacteriuria
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 10
Sponsor: The Second Hospital of Nanjing Medical University
Location: Department of Microbiota Medicine & Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu
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.
Eligibility Criteria
Inclusion Criteria:
1. Age ≥18 years, both sexes.
2. Recurrent UTI (symptomatic UTI or asymptomatic bacteriuria), with ≥2 episodes in the past 6 months or ≥3 episodes in the past year.
3. 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).
4. Physically eligible and willing to receive colonic TET tube placement and WMT treatment.
5. Able to provide informed consent and comply with scheduled follow-up visits and specimen collection.
Exclusion Criteria:
1. Received effective antimicrobial therapy within 48 hours before WMT.
2. Unable to tolerate colonoscopy or TET tube placement.
3. Severe comorbidities with expected survival less than 6 months.
4. Pregnant or lactating women.
5. Other conditions deemed unsuitable for enrollment by the investigator.
Source: ClinicalTrials.gov (NCT07816913). StuddyBuddy aggregates publicly available trial information.