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Research on Fecal Microbiota Transplantation for Recurrent Urinary Tract Infections

A Multicenter, Randomized Controlled Trial of Fecal Microbiota Transplantation to Prevent Recurrent Urinary Tract Infections

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110179
Enrollment
Unknown
Registered
2025-10-09
Start date
2025-10-15
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Urinary Tract Infections

Interventions

Control group:After conventional therapy (targeted antimicrobial therapy directed against the uropathogen identified by microbiological testing), no further intervention is given.

Sponsors

Department of Infectious Diseases, First Affiliated Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Enrollment Criteria : Patients may choose to enter the study when they meet all of the following criteria 1. Age >=18 years old and <=80 years old, male or female; 2. No less than 3 episodes of lower urinary tract infection in the past 12 months or no less than 2 lower urinary tract infections in 6 months; 3. The most recent recurrence of lower urinary tract infection has been treated to achieve symptom resolution, and the therapeutic dose of antibiotics has been discontinued, and at least one of the following conditions is met: (1) Mid-section urine bacterial culture < 10^5 CFU/mL (after receiving the test results after the most recent improvement); (2) Urine white blood cell count < 5/HP, and if white blood cells can be measured in routine urine test, < 25/µL must be met 4. Patients or family members are able to understand the study protocol, are willing to participate in this study, and sign the informed consent form.

Exclusion criteria

Exclusion criteria: Exclusion criteria 1. Severe primary disecases of the cardiovascular, cerebrovascular, or hematopoietic systems. 2. Diabetes mellitus with poor glycaemic control (HbA1c > 7.5 %). 3. Genital-tract malformation, acute genital-tract infection, or genital-tract malignancy. 4. Genitourinary tuberculosis or acute pyelonephritis. 5. Vesico-ureteric reflux or urinary diversion. 6. Polycystic kidney disease, neurogenic bladder, indwelling catheter, or any obstructive uropathy deemed by the investigator to be caused by urinary stones, tumour, or fibrosis. 7. eGFR 1.5 × ULN, AST or ALT > 2 × ULN). 9. Use of immunosuppressive agents or systemic corticosteroids > 10 mg/day. 10. Receipt of any investigational drug or participation in another interventional clinical trial within 30 days before screening. 11. History of alcohol or drug abuse, or psychiatric disorder that could compromise compliance. 12. Any condition that, in the opinion of the investigator, renders the subject unsuitable for enrolment.

Design outcomes

Primary

MeasureTime frame
Fecal 16s rDNA sequencing results;Recurrence time and number of treatments;

Secondary

MeasureTime frame
Immunological indicators;Metabolite characteristics;Proteomic characteristics;

Countries

China

Contacts

Public ContactJiabin Li

The First Affiliated Hospital of Anhui Medical University

Lijiabin@ahmu.edu.cn+86 189 5601 8570

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026