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| Name | Class |
|---|---|
| University of Helsinki | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Feacal microbial transplantation (FMT) | Experimental |
| |
| Placebo transplantation (PT), transplantation with coloured 0,9% NaCl-solution | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Feacal microbial transplantation (FMT) | Biological | Feacal microbial transplantation (FMT) |
|
| 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 |
| 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 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sari Pakkanen, PhD | Contact | +358 50 4482769 | +358 | vti-tutkimus@hus.fi |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meilahti Vaccine Research Center, Helsinki University Central Hospital | Recruiting | Helsinki | 00290 | Finland |
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| Label | URL |
|---|---|
| HUS informational website for recruitment | View source |
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| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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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)
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Unblinded team takes care of fecal microbiota transplantion but does not participate in other parts of the trial.
| Placebo transplantation (PT) | Other | Transplantation with coloured 0,9% NaCl-solution |
|
| 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 |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |