Menu
Recruiting NCT06050148

Faecal Microbiota Transplantation as Means of Preventing Recurrent Urinary Tract Infections

Phase II / Phase III Interventional Recurrent Urinary Tract Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Feacal microbial transplantation (FMT), Placebo transplantation (PT).
Who it may be relevant to
Registry conditions: Recurrent Urinary Tract Infection. Basic parameters: 18 years — 90 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Finland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

This study investigates Faecal microbiota transplantation (FMT) in prevention of recurrent urinary tract infections (UTIs) caused either by sensitive E. coli or ESBL-E. coli.

Interventions

  • Biological Feacal microbial transplantation (FMT)
    Feacal microbial transplantation (FMT)
  • Other Placebo transplantation (PT)
    Transplantation with coloured 0,9% NaCl-solution

Primary outcome measures

  • mean number of UTI episodes after FMT among patients with recurrent UTI [Time frame: 12 months]
  • proportion of participants with UTI after FMT among patients with recurrent UTI [Time frame: 12 months]
Secondary outcome measures (12)
  • mean number of UTI episodes caused by sensitive E. colis after FMT among patients with recent non-ESBL/MDR UTIs [Time frame: 12 months]
  • proportion of participants with UTIs caused by sensitive E. colis after FMT among patients with recent non-ESBL/MDR UTIs [Time frame: 12 months]
  • mean number of UTI episodes caused by ESBL/MDR E. colis after FMT among patients with recent ESBL/MDR UTIs [Time frame: 12 months]
  • proportion of participants with UTIs caused by ESBL/MDR E. colis after FMT among patients with recent ESBL/MDR UTIs [Time frame: 12 months]
  • identifying groups of bacteria associated with smaller number of UTI episodes after FMT [Time frame: 12 months]
  • the duration of successful prevention by FMT [Time frame: 1-5 years]
  • proportion of participants with recurrent UTI and concurrent intestinal MDR colonisation with the same strain [Time frame: 12 months]
  • proportion of participants with intestinal ESBL/MDR eradicated after FMT [Time frame: 1-12 months]
  • confirm whether the uropathogen are identical before and after FMT [Time frame: 12 months]
  • number of antibiotic courses received by FMT versus placebo recipients [Time frame: 12 months]
  • proportion of participants with gastrointestinal symptoms assessed by GSRS scores before and after FMT [Time frame: 1-12 months]
  • proportion of participants with mild to severe depression assessed by BDI scores before and after FMT [Time frame: 1-12 months]

Eligibility criteria

Inclusion criteria

  • Female subjects aged ≥18
  • History of recurrent UTI: at least two episodes of UTI over the past 6 months or at least three episodes over the past year, most recent episode within the past three months
  • Written informed consent

Exclusion criteria

  • Suspected non-compliance
  • Diagnosis of a gastrointestinal disease
  • Pregnancy
  • Immunosuppression
  • Any kind of permanent urinary catheter or intermittent urinary catheterization
  • Any other criteria which, in the investigator's opinion, would compromise the ability of the subject to participate in the study, the subject's well-being, or the outcome of the study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

Finland · 1 center
  • Meilahti Vaccine Research Center, Helsinki University Central Hospital — Helsinki

Identifiers

NCT: NCT06050148 · FMT-UTI

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗