Clinical trial NCT06050148: Faecal Microbiota Transplantation as Means of Preventing Recurrent Urinary Tract Infections
Official title: Faecal Microbiota Transplantation as Means of Preventing Recurrent Urinary Tract Infections
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Recurrent Urinary Tract Infection
Keywords: Urinary tract infection, Faecal microbiota transplantation, ESBL, Antimicrobial resistance
Recurrent urinary tract infection
UTI
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: University of Helsinki
First posted: 2023-09-22
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: mean number of UTI episodes after FMT among patients with recurrent UTI
timeFrame: 12 months
measure: proportion of participants with UTI after FMT among patients with recurrent UTI
timeFrame: 12 months
Secondary outcomes:
measure: mean number of UTI episodes caused by sensitive E. colis after FMT among patients with recent non-ESBL/MDR UTIs
timeFrame: 12 months
measure: proportion of participants with UTIs caused by sensitive E. colis after FMT among patients with recent non-ESBL/MDR UTIs
timeFrame: 12 months
measure: mean number of UTI episodes caused by ESBL/MDR E. colis after FMT among patients with recent ESBL/MDR UTIs
timeFrame: 12 months
measure: proportion of participants with UTIs caused by ESBL/MDR E. colis after FMT among patients with recent ESBL/MDR UTIs
timeFrame: 12 months
measure: identifying groups of bacteria associated with smaller number of UTI episodes after FMT
timeFrame: 12 months
measure: the duration of successful prevention by FMT
timeFrame: 1-5 years
measure: proportion of participants with recurrent UTI and concurrent intestinal MDR colonisation with the same strain
timeFrame: 12 months
measure: proportion of participants with intestinal ESBL/MDR eradicated after FMT
timeFrame: 1-12 months
measure: confirm whether the uropathogen are identical before and after FMT
timeFrame: 12 months
measure: number of antibiotic courses received by FMT versus placebo recipients
timeFrame: 12 months
measure: proportion of participants with gastrointestinal symptoms assessed by GSRS scores before and after FMT
timeFrame: 1-12 months
measure: proportion of participants with mild to severe depression assessed by BDI scores before and after FMT
timeFrame: 1-12 months
measure: mean number of health-related quality of life (HRQoL) scores assessed by 15D before and after FMT
timeFrame: 1-12 months
measure: description of groups of bacteria in faecal and urine microbiome before and after FMT
timeFrame: 12 months
measure: human urine and serum metabolic profiles before and after FMT
timeFrame: 12 months
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Meilahti Vaccine Research Center, Helsinki University Central Hospital
Study officials:
References: