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Clinical Trials/NCT06050148
NCT06050148RecruitingPhase 2

Faecal Microbiota Transplantation as Means of Preventing Recurrent Urinary Tract Infections

Helsinki University Central Hospital2 sites in 1 country100 target enrollmentStarted: August 1, 2023Last updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Status
Recruiting
Enrollment
100
Locations
2
Primary Endpoint
proportion of participants with UTI after FMT among patients with recurrent UTI
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Masking Description

Unblinded team takes care of fecal microbiota transplantion but does not participate in other parts of the trial.

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
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

Study Sites (2)

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