Faecal Microbiota Transplantation as Means of Preventing Recurrent Urinary Tract Infections

Phase 2

Recruiting

• Conditions: Recurrent Urinary Tract Infection
• Interventions: Biological: Feacal microbial transplantation (FMT); Other: Placebo transplantation (PT)

• Registration Number: NCT06050148
• Lead Sponsor: Helsinki University Central Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-01
• Study First Submitted: 2023-08-29
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-15
• Last Update Submitted: 2023-09-15
• Study First Posted: 2023-09-22
• Last Update Posted: 2023-09-22
• Primary Completion: 2028-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Feacal microbial transplantation (FMT)	Feacal microbial transplantation (FMT)	-
Placebo transplantation (PT), transplantation with coloured 0,9% NaCl-solution	Placebo transplantation (PT)	-

Primary Outcome Measures

Name	Time	Method
proportion of participants with UTI after FMT among patients with recurrent UTI	12 months
mean number of UTI episodes after FMT among patients with recurrent UTI	12 months

Secondary Outcome Measures

Name	Time	Method
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 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
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 ESBL/MDR E. colis after FMT among patients with recent ESBL/MDR UTIs	12 months
the duration of successful prevention by FMT	1-5 years
proportion of participants with intestinal ESBL/MDR eradicated after FMT	1-12 months
human urine and serum metabolic profiles before and after FMT	12 months	assessed by a 1H-Nuclear Magnetic Resonance-based metabolomic approach
proportion of participants with UTIs 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
mean number of UTI episodes 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
proportion of participants with recurrent UTI and concurrent intestinal MDR colonisation with the same strain	12 months

Trial Locations

Locations (1)

Meilahti Vaccine Research Center, Helsinki University Central Hospital; 🇫🇮 Helsinki, Finland