Faecal Microbiota Transplantation as Means of Preventing Recurrent Urinary Tract Infections

Recurrent Urinary Tract Infection Clinical Trial

— FMT-UTI  

Official title:

Faecal Microbiota Transplantation as Means of Preventing Recurrent Urinary Tract Infections

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06050148
• Other study ID #: FMT-UTI
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: August 1, 2023
• Est. completion date: December 31, 2029

Study information

• Verified date: September 2023
• Source: Helsinki University Central Hospital
• Contact: Sari Pakkanen, PhD
• Phone: +358 50 4482769
• Email: vti-tutkimus[@]hus.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Recurrence
• Recurrent Urinary Tract Infection
• Urinary Tract Infections

Intervention

Biological:
• Feacal microbial transplantation (FMT)
Feacal microbial transplantation (FMT)

Other:
• Placebo transplantation (PT)
Transplantation with coloured 0,9% NaCl-solution

Locations

Country	Name	City	State
Finland	Meilahti Vaccine Research Center, Helsinki University Central Hospital	Helsinki

Sponsors (2)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	University of Helsinki

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean number of UTI episodes after FMT among patients with recurrent UTI		12 months
Primary	proportion of participants with UTI after FMT among patients with recurrent UTI		12 months
Secondary	mean number of UTI episodes caused by sensitive E. colis after FMT among patients with recent non-ESBL/MDR UTIs		12 months
Secondary	proportion of participants with UTIs caused by sensitive E. colis after FMT among patients with recent non-ESBL/MDR UTIs		12 months
Secondary	mean number of UTI episodes caused by ESBL/MDR E. colis after FMT among patients with recent ESBL/MDR UTIs		12 months
Secondary	proportion of participants with UTIs caused by ESBL/MDR E. colis after FMT among patients with recent ESBL/MDR UTIs		12 months
Secondary	identifying groups of bacteria associated with smaller number of UTI episodes after FMT		12 months
Secondary	the duration of successful prevention by FMT		1-5 years
Secondary	proportion of participants with recurrent UTI and concurrent intestinal MDR colonisation with the same strain		12 months
Secondary	proportion of participants with intestinal ESBL/MDR eradicated after FMT		1-12 months
Secondary	confirm whether the uropathogen are identical before and after FMT	evaluated by antimicrobial sensitivity profile and whole-genome sequencing	12 months
Secondary	number of antibiotic courses received by FMT versus placebo recipients		12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	description of groups of bacteria in faecal and urine microbiome before and after FMT		12 months
Secondary	human urine and serum metabolic profiles before and after FMT	assessed by a 1H-Nuclear Magnetic Resonance-based metabolomic approach	12 months

External Links

•   HUS informational website for recruitment