Faecal Microbiota Transplantation as Means of Preventing Recurrent Urinary Tract Infections

Study Overview
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Brief Summary
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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.

Official Title
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Faecal Microbiota Transplantation as Means of Preventing Recurrent Urinary Tract Infections

Conditions
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Recurrent Urinary Tract Infection

Intervention / Treatment
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* Biological: Feacal microbial transplantation (FMT)
* Other: Placebo transplantation (PT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Feacal microbial transplantation (FMT)<br> | Biological: Feacal microbial transplantation (FMT)<br>* Feacal microbial transplantation (FMT)<br>|
| Placebo Comparator: Placebo transplantation (PT), transplantation with coloured 0,9% NaCl-solution<br> | Other: Placebo transplantation (PT)<br>* Transplantation with coloured 0,9% NaCl-solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| 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 |  | 12 months | 
| proportion of participants with UTIs caused by sensitive E. colis after FMT among patients with recent non-ESBL/MDR UTIs |  | 12 months | 
| 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 | 
| confirm whether the uropathogen are identical before and after FMT | evaluated by antimicrobial sensitivity profile and whole-genome sequencing | 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 | 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 | 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 | 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 |  | 12 months | 
| human urine and serum metabolic profiles before and after FMT | assessed by a 1H-Nuclear Magnetic Resonance-based metabolomic approach | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urinary tract infection, Faecal microbiota transplantation, ESBL, Antimicrobial resistance, Recurrent urinary tract infection, UTI