Faecal Microbiota Transplantation as Means of Preventing Recurrent Urinary Tract Infections (FMT-UTI)

September 15, 2023 updated by: Anu Kantele, Helsinki University Central Hospital
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Finland
      • Helsinki, Finland, 00290
        • Recruiting
        • Meilahti Vaccine Research Center, Helsinki University Central Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Hanni Häkkinen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Feacal microbial transplantation (FMT)
Biological: Feacal microbial transplantation (FMT)
Feacal microbial transplantation (FMT)
Placebo Comparator: Placebo transplantation (PT), transplantation with coloured 0,9% NaCl-solution
Other: Placebo transplantation (PT)
Transplantation with coloured 0,9% NaCl-solution

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
mean number of UTI episodes after FMT among patients with recurrent UTI
Time Frame: 12 months
12 months
proportion of participants with UTI after FMT among patients with recurrent UTI
Time Frame: 12 months
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
mean number of UTI episodes caused by sensitive E. colis after FMT among patients with recent non-ESBL/MDR UTIs
Time Frame: 12 months
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
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
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
12 months
identifying groups of bacteria associated with smaller number of UTI episodes after FMT
Time Frame: 12 months
12 months
the duration of successful prevention by FMT
Time Frame: 1-5 years
1-5 years
proportion of participants with recurrent UTI and concurrent intestinal MDR colonisation with the same strain
Time Frame: 12 months
12 months
proportion of participants with intestinal ESBL/MDR eradicated after FMT
Time Frame: 1-12 months
1-12 months
confirm whether the uropathogen are identical before and after FMT
Time Frame: 12 months
evaluated by antimicrobial sensitivity profile and whole-genome sequencing
12 months
number of antibiotic courses received by FMT versus placebo recipients
Time Frame: 12 months
12 months
proportion of participants with gastrointestinal symptoms assessed by GSRS scores before and after FMT
Time Frame: 1-12 months
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
1-12 months
proportion of participants with mild to severe depression assessed by BDI scores before and after FMT
Time Frame: 1-12 months
Beck's Depression Inventory: 21-question multiple-choice self-report inventory, higher scores for more severe depression
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
Quality of life -questionnaire (15D): a generic, comprehensive (15-dimensional), self-administered questionnaire, lower scores for better HRQoL
1-12 months
description of groups of bacteria in faecal and urine microbiome before and after FMT
Time Frame: 12 months
12 months
human urine and serum metabolic profiles before and after FMT
Time Frame: 12 months
assessed by a 1H-Nuclear Magnetic Resonance-based metabolomic approach
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Helsinki University Central Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Helsinki

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 29, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 22, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 22, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FMT-UTI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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