Faecal Microbiota Transplantation as Means of Preventing Recurrent Urinary Tract Infections

Helsinki University Central Hospital1 site in 1 country100 target enrollmentAugust 1, 2023

ConditionsRecurrent Urinary Tract Infection

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Recurrent Urinary Tract Infection
Sponsor: Helsinki University Central Hospital
Enrollment: 100
Locations: 1
Primary Endpoint: proportion of participants with UTI after FMT among patients with recurrent UTI
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

August 1, 2023

End Date

December 31, 2029

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Helsinki University Central Hospital

Responsible Party

Principal Investigator

Anu Kantele

Professor of infectious diseases, University of Helsinki and Helsinki University Hospital, Department of infectious diseases, Meilahti Vaccine Research Center MeVac, Helsinki, Finland

Helsinki University Central Hospital

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

proportion of participants with UTI after FMT among patients with recurrent UTI

Time Frame: 12 months

mean number of UTI episodes after FMT among patients with recurrent UTI

Time Frame: 12 months

Secondary Outcomes

confirm whether the uropathogen are identical before and after FMT(12 months)
proportion of participants with mild to severe depression assessed by BDI scores before and after FMT(1-12 months)
mean number of health-related quality of life (HRQoL) scores assessed by 15D before and after FMT(1-12 months)
description of groups of bacteria in faecal and urine microbiome before and after FMT(12 months)
mean number of UTI episodes caused by sensitive E. colis after FMT among patients with recent non-ESBL/MDR UTIs(12 months)
proportion of participants with UTIs caused by ESBL/MDR E. colis after FMT among patients with recent ESBL/MDR UTIs(12 months)
the duration of successful prevention by FMT(1-5 years)
proportion of participants with intestinal ESBL/MDR eradicated after FMT(1-12 months)
human urine and serum metabolic profiles before and after FMT(12 months)
proportion of participants with UTIs caused by sensitive E. colis after FMT among patients with recent non-ESBL/MDR UTIs(12 months)
number of antibiotic courses received by FMT versus placebo recipients(12 months)
proportion of participants with gastrointestinal symptoms assessed by GSRS scores before and after FMT(1-12 months)
mean number of UTI episodes caused by ESBL/MDR E. colis after FMT among patients with recent ESBL/MDR UTIs(12 months)
identifying groups of bacteria associated with smaller number of UTI episodes after FMT(12 months)
proportion of participants with recurrent UTI and concurrent intestinal MDR colonisation with the same strain(12 months)