NCT06050148

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
44mo left

Started Aug 2023

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress43%
Aug 2023Dec 2029

Study Start

First participant enrolled

August 1, 2023

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

August 29, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

September 22, 2023

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

September 22, 2023

Status Verified

September 1, 2023

Enrollment Period

5.4 years

First QC Date

August 29, 2023

Last Update Submit

September 15, 2023

Conditions

Recurrent Urinary Tract Infection

Keywords

Urinary tract infection, Faecal microbiota transplantation, ESBL, Antimicrobial resistanceRecurrent urinary tract infectionUTI

Outcome Measures

Primary Outcomes (2)

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

    12 months

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

    12 months

Secondary Outcomes (15)

  • 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 sensitive E. colis after FMT among patients with recent non-ESBL/MDR UTIs

    12 months

  • mean number of UTI episodes caused by ESBL/MDR E. colis after FMT among patients with recent 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

  • identifying groups of bacteria associated with smaller number of UTI episodes after FMT

    12 months

  • +10 more secondary outcomes

Study Arms (2)

Feacal microbial transplantation (FMT)

EXPERIMENTAL
Biological: Feacal microbial transplantation (FMT)

Placebo transplantation (PT), transplantation with coloured 0,9% NaCl-solution

PLACEBO COMPARATOR
Other: Placebo transplantation (PT)

Interventions

Feacal microbial transplantation (FMT)BIOLOGICAL

Feacal microbial transplantation (FMT)

Feacal microbial transplantation (FMT)
Placebo transplantation (PT)OTHER

Transplantation with coloured 0,9% NaCl-solution

Placebo transplantation (PT), transplantation with coloured 0,9% NaCl-solution

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meilahti Vaccine Research Center, Helsinki University Central Hospital

Helsinki, 00290, Finland

RECRUITING

Related Links

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Central Study Contacts

Sari Pakkanen, PhD

CONTACT

+358 50 4482769vti-tutkimus@hus.fi

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Unblinded team takes care of fecal microbiota transplantion but does not participate in other parts of the trial.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Part A: Double-blinded randomised trial for volunteers with recurrent UTIs with 1:1 FMT and placebo (PT) arms undergoing transfer of feces or placebo, respectively (Groups 1 and 2). Randomisation with respect to ESBL positivity (equal numbers of ESBL-positive in FMT and PT arms) and menopause. The groups will undergo an intensive 12-month follow-up. (Part B: a concomitant separate non-randomised follow-up study for non-trial participants, recruited separately, groups 3 and 4, no further description)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of infectious diseases, University of Helsinki and Helsinki University Hospital, Department of infectious diseases, Meilahti Vaccine Research Center MeVac, Helsinki, Finland

Study Record Dates

First Submitted

August 29, 2023

First Posted

September 22, 2023

Study Start

August 1, 2023

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2029

Last Updated

September 22, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)