Faecal Microbiota Transplantation as Means of Preventing Recurrent Urinary Tract Infections

NCT ID: NCT06050148

Last Updated: 2023-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2029-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Recurrent Urinary Tract Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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)
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

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

Study Groups

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Feacal microbial transplantation (FMT)

Group Type EXPERIMENTAL

Feacal microbial transplantation (FMT)

Intervention Type BIOLOGICAL

Feacal microbial transplantation (FMT)

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

Group Type PLACEBO_COMPARATOR

Placebo transplantation (PT)

Intervention Type OTHER

Transplantation with coloured 0,9% NaCl-solution

Interventions

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Feacal microbial transplantation (FMT)

Feacal microbial transplantation (FMT)

Intervention Type BIOLOGICAL

Placebo transplantation (PT)

Transplantation with coloured 0,9% NaCl-solution

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Helsinki

OTHER

Sponsor Role collaborator

Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Anu Kantele

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Meilahti Vaccine Research Center, Helsinki University Central Hospital

Helsinki, , Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Sari Pakkanen, PhD

Role: CONTACT

+358 50 4482769 ext. +358

Facility Contacts

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Sari Pakkanen, PhD

Role: primary

Meilahti Vaccine Research Center

Role: backup

Related Links

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Other Identifiers

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FMT-UTI

Identifier Type: -

Identifier Source: org_study_id

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