Recurrent Urinary Tract Infection
Conditions
Keywords
Urinary tract infection, Faecal microbiota transplantation, ESBL, Antimicrobial resistance, Recurrent urinary tract infection, UTI
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.
Interventions
BIOLOGICALFeacal microbial transplantation (FMT)
Feacal microbial transplantation (FMT)
OTHERPlacebo transplantation (PT)
Transplantation with coloured 0,9% NaCl-solution
Sponsors
University of Helsinki
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Unblinded team takes care of fecal microbiota transplantion but does not participate in other parts of the trial.
Intervention 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)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mean number of UTI episodes after FMT among patients with recurrent UTI | 12 months |
| proportion of participants with UTI after FMT among patients with recurrent UTI | 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mean number of UTI episodes caused by ESBL/MDR E. colis after FMT among patients with recent ESBL/MDR UTIs | 12 months | — |
| proportion of participants with UTIs caused by ESBL/MDR E. colis after FMT among patients with recent ESBL/MDR UTIs | 12 months | — |
| identifying groups of bacteria associated with smaller number of UTI episodes after FMT | 12 months | — |
| the duration of successful prevention by FMT | 1-5 years | — |
| proportion of participants with recurrent UTI and concurrent intestinal MDR colonisation with the same strain | 12 months | — |
| proportion of participants with intestinal ESBL/MDR eradicated after FMT | 1-12 months | — |
| mean number of UTI episodes caused by sensitive E. colis after FMT among patients with recent non-ESBL/MDR UTIs | 12 months | — |
| number of antibiotic courses received by FMT versus placebo recipients | 12 months | — |
| proportion of participants with gastrointestinal symptoms assessed by GSRS scores before and after FMT | 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 |
| proportion of participants with mild to severe depression assessed by BDI scores before and after FMT | 1-12 months | 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 | 1-12 months | 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 | 12 months | — |
| human urine and serum metabolic profiles before and after FMT | 12 months | assessed by a 1H-Nuclear Magnetic Resonance-based metabolomic approach |
| confirm whether the uropathogen are identical before and after FMT | 12 months | evaluated by antimicrobial sensitivity profile and whole-genome sequencing |
| proportion of participants with UTIs caused by sensitive E. colis after FMT among patients with recent non-ESBL/MDR UTIs | 12 months | — |
Countries
Finland
Contacts
Primary ContactSari Pakkanen, PhD
Outcome results
None listed