Faecal Microbiota Transplantation as Means of Preventing Recurrent Urinary Tract Infections (FMT-UTI)

Helsinki University Central Hospital (HUCH)

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Recurrent Urinary Tract Infection

Treatments: Biological: Feacal microbial transplantation (FMT); Other: Placebo transplantation (PT)

Study type: Interventional

Funder types: Other

Identifiers

NCT06050148

FMT-UTI

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

Feacal microbial transplantation (FMT)

Experimental group

Treatment:

Biological: Feacal microbial transplantation (FMT)

Placebo transplantation (PT), transplantation with coloured 0,9% NaCl-solution

Placebo Comparator group

Treatment:

Other: Placebo transplantation (PT)