Faecal Microbiota Transplantation as Means of Preventing Recurrent Urinary Tract Infections
NCT ID: NCT06050148
Last Updated: 2023-09-22
Study Results
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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RECRUITING
PHASE2/PHASE3
100 participants
INTERVENTIONAL
2023-08-01
2029-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
(Part B: a concomitant separate non-randomised follow-up study for non-trial participants, recruited separately, groups 3 and 4, no further description)
PREVENTION
TRIPLE
Study Groups
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Feacal microbial transplantation (FMT)
Feacal microbial transplantation (FMT)
Feacal microbial transplantation (FMT)
Placebo transplantation (PT), transplantation with coloured 0,9% NaCl-solution
Placebo transplantation (PT)
Transplantation with coloured 0,9% NaCl-solution
Interventions
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Feacal microbial transplantation (FMT)
Feacal microbial transplantation (FMT)
Placebo transplantation (PT)
Transplantation with coloured 0,9% NaCl-solution
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
90 Years
FEMALE
Yes
Sponsors
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University of Helsinki
OTHER
Helsinki University Central Hospital
OTHER
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
Locations
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Meilahti Vaccine Research Center, Helsinki University Central Hospital
Helsinki, , Finland
Countries
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Central Contacts
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Facility Contacts
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Related Links
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HUS informational website for recruitment
Other Identifiers
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FMT-UTI
Identifier Type: -
Identifier Source: org_study_id
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