Faecal Microbiota Transplantation as Means of Preventing Recurrent Urinary Tract Infections

Phase 3RecruitingNCT06050148

Helsinki University Central Hospital100 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

100

Conditions

Recurrent Urinary Tract Infection

Interventions

Feacal microbial transplantation (FMT)BIOLOGICAL

Feacal microbial transplantation (FMT)

Placebo transplantation (PT)OTHER

Transplantation with coloured 0,9% NaCl-solution

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Meilahti Vaccine Research Center, Helsinki University Central Hospital

Helsinki, Finland

RECRUITING

Outcomes

Primary Outcomes

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 Outcomes

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

Central Contacts

Sari Pakkanen, PhD

CONTACT

+358 50 4482769 vti-tutkimus@hus.fi

Data from ClinicalTrials.gov

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