Recurrent Urinary Tract InfectionPhase 2/3FMT-UTINCT06050148
Faecal Microbiota Transplantation as Means of Preventing Recurrent Urinary Tract Infections
A Phase 2/3 study testing Feacal microbial transplantation (FMT) in people with Recurrent Urinary Tract Infection, run by Helsinki University Central Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Recurrent Urinary Tract Infection
- What is being tested?
- Feacal microbial transplantation (FMT)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteFinland
- Study dates
- 1 Aug 2023to 31 Dec 2029
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
Meilahti Vaccine Research Center, Helsinki University Central Hospital
Helsinki, 00290
Sari Pakkanen, PhD, sari.pakkanen@hus.fi
Meilahti Vaccine Research Center, vaccine@hus.fi
About this study
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.
- Conditions
- Recurrent Urinary Tract Infection
- Being tested
- Feacal microbial transplantation (FMT), Placebo transplantation (PT)
- Keywords
- Urinary tract infection, Faecal microbiota transplantation, ESBL, Antimicrobial resistance, Recurrent urinary tract infection, UTI
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feacal microbial transplantation (FMT)Biological
Feacal microbial transplantation (FMT)
Placebo transplantation (PT)Other
Transplantation with coloured 0,9% NaCl-solution
| Study group | Role | What they receive |
|---|---|---|
| Feacal microbial transplantation (FMT) | Experimental | Not described Receives: Biological: Feacal microbial transplantation (FMT) |
| Placebo transplantation (PT), transplantation with coloured 0,9% NaCl-solution | Placebo comparator | Not described Receives: Other: Placebo transplantation (PT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean number of UTI episodes after FMT among patients with recurrent UTI
Measured: 12 months
proportion of participants with UTI after FMT among patients with recurrent UTI
Measured: 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
Measured: 12 months
proportion of participants with UTIs caused by sensitive E. colis after FMT among patients with recent non-ESBL/MDR UTIs
Measured: 12 months
mean number of UTI episodes caused by ESBL/MDR E. colis after FMT among patients with recent ESBL/MDR UTIs
Measured: 12 months
proportion of participants with UTIs caused by ESBL/MDR E. colis after FMT among patients with recent ESBL/MDR UTIs
Measured: 12 months
identifying groups of bacteria associated with smaller number of UTI episodes after FMT
Measured: 12 months
the duration of successful prevention by FMT
Measured: 1-5 years
proportion of participants with recurrent UTI and concurrent intestinal MDR colonisation with the same strain
Measured: 12 months
proportion of participants with intestinal ESBL/MDR eradicated after FMT
Measured: 1-12 months
confirm whether the uropathogen are identical before and after FMT
evaluated by antimicrobial sensitivity profile and whole-genome sequencing
Measured: 12 months
number of antibiotic courses received by FMT versus placebo recipients
Measured: 12 months
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
Measured: 1-12 months
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
Measured: 1-12 months
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
Measured: 1-12 months
description of groups of bacteria in faecal and urine microbiome before and after FMT
Measured: 12 months
human urine and serum metabolic profiles before and after FMT
assessed by a 1H-Nuclear Magnetic Resonance-based metabolomic approach
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start1 Aug 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Urinary Tract InfectionStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Helsinki
- Responsible party
- Principal investigator, Anu Kantele, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06050148
- Sponsor's protocol ID
- FMT-UTI
- Acronym
- FMT-UTI
- Status last verified
- Sep 2023
- First submitted
- 29 Aug 2023
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Faecal Microbiota Transplantation as Means of Preventing Recurrent Urinary Tract Infections
- ClinicalTrials.gov ID
- NCT06050148
- Acronym / sponsor ID
- FMT-UTI / FMT-UTI
- Conditions
- Recurrent Urinary Tract Infection
- Keywords
- Urinary tract infection, Faecal microbiota transplantation, ESBL, Antimicrobial resistance, Recurrent urinary tract infection, UTI
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- University of Helsinki
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 22 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- Suspected non-compliance
- Diagnosis of a gastrointestinal disease
- Pregnancy
- Immunosuppression
- Any kind of permanent urinary catheter or intermittent urinary catheterization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Feacal microbial transplantation (FMT)Feacal microbial transplantation (FMT) | Biological | Feacal microbial transplantation (FMT) |
| Placebo transplantation (PT)Transplantation with coloured 0,9% NaCl-solution | Other | Placebo transplantation (PT), transplantation with coloured 0,9% NaCl-solution |
Primary outcome
mean number of UTI episodes after FMT among patients with recurrent UTI
Time frame: 12 months
proportion of participants with UTI after FMT among patients with recurrent UTI
Time frame: 12 months
15 secondary outcomes
mean number of UTI episodes caused by sensitive E. colis after FMT among patients with recent non-ESBL/MDR UTIs
Time frame: 12 months
proportion of participants with UTIs caused by sensitive E. colis after FMT among patients with recent non-ESBL/MDR UTIs
Time frame: 12 months
mean number of UTI episodes caused by ESBL/MDR E. colis after FMT among patients with recent ESBL/MDR UTIs
Time frame: 12 months
proportion of participants with UTIs caused by ESBL/MDR E. colis after FMT among patients with recent ESBL/MDR UTIs
Time frame: 12 months
identifying groups of bacteria associated with smaller number of UTI episodes after FMT
Time frame: 12 months
the duration of successful prevention by FMT
Time frame: 1-5 years
proportion of participants with recurrent UTI and concurrent intestinal MDR colonisation with the same strain
Time frame: 12 months
proportion of participants with intestinal ESBL/MDR eradicated after FMT
Time frame: 1-12 months
confirm whether the uropathogen are identical before and after FMT
Time frame: 12 months
number of antibiotic courses received by FMT versus placebo recipients
Time frame: 12 months
proportion of participants with gastrointestinal symptoms assessed by GSRS scores before and after FMT
Time frame: 1-12 months
proportion of participants with mild to severe depression assessed by BDI scores before and after FMT
Time frame: 1-12 months
mean number of health-related quality of life (HRQoL) scores assessed by 15D before and after FMT
Time frame: 1-12 months
description of groups of bacteria in faecal and urine microbiome before and after FMT
Time frame: 12 months
human urine and serum metabolic profiles before and after FMT
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- HUS informational website for recruitmentLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Feacal microbial transplantation (FMT) in people with Recurrent Urinary Tract Infection, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sari Pakkanen, PhD (+358 50 4482769 ext. +358, vti-tutkimus@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean number of UTI episodes after FMT among patients with recurrent UTI (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.