Back to resultsFaecal Microbiota Transplantation as Means of Preventing Recurrent Urinary Tract Infections (FMT-UTI)
Primary Purpose
Recurrent Urinary Tract Infection
Status
Recruiting
Phase
Phase 2
Locations
Finland
Study Type
Interventional
Intervention
Feacal microbial transplantation (FMT)
Placebo transplantation (PT)
Sponsored by
About this trial
This is an interventional prevention trial for Recurrent Urinary Tract Infection focused on measuring Urinary tract infection, Faecal microbiota transplantation, ESBL, Antimicrobial resistance, Recurrent urinary tract infection, UTI
Eligibility Criteria
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
Sites / Locations
- Meilahti Vaccine Research Center, Helsinki University Central HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Feacal microbial transplantation (FMT)
Placebo transplantation (PT), transplantation with coloured 0,9% NaCl-solution
Arm Description
Outcomes
Primary Outcome Measures
mean number of UTI episodes after FMT among patients with recurrent UTI
proportion of participants with UTI after FMT among patients with recurrent UTI
Secondary Outcome Measures
mean number of UTI episodes caused by sensitive E. colis after FMT among patients with recent non-ESBL/MDR UTIs
proportion of participants with UTIs caused by sensitive E. colis after FMT among patients with recent non-ESBL/MDR UTIs
mean number of UTI episodes caused by ESBL/MDR E. colis after FMT among patients with recent ESBL/MDR UTIs
proportion of participants with UTIs caused by ESBL/MDR E. colis after FMT among patients with recent ESBL/MDR UTIs
identifying groups of bacteria associated with smaller number of UTI episodes after FMT
the duration of successful prevention by FMT
proportion of participants with recurrent UTI and concurrent intestinal MDR colonisation with the same strain
proportion of participants with intestinal ESBL/MDR eradicated after FMT
confirm whether the uropathogen are identical before and after FMT
evaluated by antimicrobial sensitivity profile and whole-genome sequencing
number of antibiotic courses received by FMT versus placebo recipients
proportion of participants with gastrointestinal symptoms assessed by GSRS scores before and after FMT
Gastrointestinal symptom rating scale -questionnaire with 15 items on a 7-level Likert scale (1-7), higher scores for more intense symptoms during the past week
proportion of participants with mild to severe depression assessed by BDI scores before and after FMT
Beck's Depression Inventory: 21-question multiple-choice self-report inventory, higher scores for more severe depression
mean number of health-related quality of life (HRQoL) scores assessed by 15D before and after FMT
Quality of life -questionnaire (15D): a generic, comprehensive (15-dimensional), self-administered questionnaire, lower scores for better HRQoL
description of groups of bacteria in faecal and urine microbiome before and after FMT
human urine and serum metabolic profiles before and after FMT
assessed by a 1H-Nuclear Magnetic Resonance-based metabolomic approach
Full Information
NCT ID
NCT06050148
First Posted
August 29, 2023
Last Updated
September 15, 2023
Sponsor
Helsinki University Central Hospital
Collaborators
University of Helsinki
1. Study Identification
Unique Protocol Identification Number
NCT06050148
Brief Title
Faecal Microbiota Transplantation as Means of Preventing Recurrent Urinary Tract Infections
Acronym
FMT-UTI
Official Title
Faecal Microbiota Transplantation as Means of Preventing Recurrent Urinary Tract Infections
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
December 31, 2028 (Anticipated)
Study Completion Date
December 31, 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital
Collaborators
University of Helsinki
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Urinary Tract Infection
Keywords
Urinary tract infection, Faecal microbiota transplantation, ESBL, Antimicrobial resistance, Recurrent urinary tract infection, UTI
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
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)
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Unblinded team takes care of fecal microbiota transplantion but does not participate in other parts of the trial.
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Feacal microbial transplantation (FMT)
Arm Type
Experimental
Arm Title
Placebo transplantation (PT), transplantation with coloured 0,9% NaCl-solution
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
Feacal microbial transplantation (FMT)
Intervention Description
Feacal microbial transplantation (FMT)
Intervention Type
Other
Intervention Name(s)
Placebo transplantation (PT)
Intervention Description
Transplantation with coloured 0,9% NaCl-solution
Primary Outcome Measure Information:
Title
mean number of UTI episodes after FMT among patients with recurrent UTI
Time Frame
12 months
Title
proportion of participants with UTI after FMT among patients with recurrent UTI
Time Frame
12 months
Secondary Outcome Measure Information:
Title
mean number of UTI episodes caused by sensitive E. colis after FMT among patients with recent non-ESBL/MDR UTIs
Time Frame
12 months
Title
proportion of participants with UTIs caused by sensitive E. colis after FMT among patients with recent non-ESBL/MDR UTIs
Time Frame
12 months
Title
mean number of UTI episodes caused by ESBL/MDR E. colis after FMT among patients with recent ESBL/MDR UTIs
Time Frame
12 months
Title
proportion of participants with UTIs caused by ESBL/MDR E. colis after FMT among patients with recent ESBL/MDR UTIs
Time Frame
12 months
Title
identifying groups of bacteria associated with smaller number of UTI episodes after FMT
Time Frame
12 months
Title
the duration of successful prevention by FMT
Time Frame
1-5 years
Title
proportion of participants with recurrent UTI and concurrent intestinal MDR colonisation with the same strain
Time Frame
12 months
Title
proportion of participants with intestinal ESBL/MDR eradicated after FMT
Time Frame
1-12 months
Title
confirm whether the uropathogen are identical before and after FMT
Description
evaluated by antimicrobial sensitivity profile and whole-genome sequencing
Time Frame
12 months
Title
number of antibiotic courses received by FMT versus placebo recipients
Time Frame
12 months
Title
proportion of participants with gastrointestinal symptoms assessed by GSRS scores before and after FMT
Description
Gastrointestinal symptom rating scale -questionnaire with 15 items on a 7-level Likert scale (1-7), higher scores for more intense symptoms during the past week
Time Frame
1-12 months
Title
proportion of participants with mild to severe depression assessed by BDI scores before and after FMT
Description
Beck's Depression Inventory: 21-question multiple-choice self-report inventory, higher scores for more severe depression
Time Frame
1-12 months
Title
mean number of health-related quality of life (HRQoL) scores assessed by 15D before and after FMT
Description
Quality of life -questionnaire (15D): a generic, comprehensive (15-dimensional), self-administered questionnaire, lower scores for better HRQoL
Time Frame
1-12 months
Title
description of groups of bacteria in faecal and urine microbiome before and after FMT
Time Frame
12 months
Title
human urine and serum metabolic profiles before and after FMT
Description
assessed by a 1H-Nuclear Magnetic Resonance-based metabolomic approach
Time Frame
12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sari Pakkanen, PhD
Phone
+358 50 4482769
Ext
+358
Email
vti-tutkimus@hus.fi
Facility Information:
Facility Name
Meilahti Vaccine Research Center, Helsinki University Central Hospital
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sari Pakkanen, PhD
Email
sari.pakkanen@hus.fi
First Name & Middle Initial & Last Name & Degree
Meilahti Vaccine Research Center
Email
vaccine@hus.fi
First Name & Middle Initial & Last Name & Degree
Hanni Häkkinen, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.hus.fi/ulosteensiirto-toistuvien-virtsatieinfektioiden-ehkaisyssa-tule-mukaan-tutkimukseen
Description
HUS informational website for recruitment
Learn more about this trial
Faecal Microbiota Transplantation as Means of Preventing Recurrent Urinary Tract Infections
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