Actively Recruiting
Faecal Microbiota Transplantation as Means of Preventing Recurrent Urinary Tract Infections
Led by Helsinki University Central Hospital · Updated on 2023-09-22
100
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
H
Helsinki University Central Hospital
Lead Sponsor
U
University of Helsinki
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying faecal microbiota transplantation (FMT) as a way to prevent recurrent urinary tract infections (UTIs) caused by either sensitive E. coli or ESBL-E. coli bacteria. This trial is a randomized, triple-blind study sponsored by Helsinki University Central Hospital, aiming to assess FMT's impact on UTI recurrence over time. Participants will be randomly assigned to receive either FMT, which involves transplanting beneficial gut bacteria, or a placebo transplantation using a colored saline solution. The study will compare these groups to evaluate the number and proportion of UTI episodes after treatment, with follow-up lasting up to 12 months and additional long-term monitoring planned for up to five years. During the study, participants will be monitored regularly to track UTI episodes, bacterial strains in urine and feces, gastrointestinal symptoms, depression levels, quality of life, and metabolic profiles. Researchers will also record antibiotic use and assess the eradication of multidrug-resistant bacteria. The total participation time may range from one to five years, with various assessments conducted throughout this period to measure the success and duration of prevention.
CONDITIONS
Brief Title
Faecal Microbiota Transplantation as Means of Preventing Recurrent Urinary Tract Infections
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female subjects aged 6518 years
- History of recurrent urinary tract infections with at least two episodes in the past 6 months or three episodes in the past year
- Most recent urinary tract infection episode within the past three months
- Written informed consent
You will not qualify if you...
- Suspected non-compliance
- Diagnosis of a gastrointestinal disease
- Pregnancy
- Immunosuppression
- Use of any permanent urinary catheter or intermittent urinary catheterization
- Any other condition that may affect participation, well-being, or study outcome as judged by the investigator
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 months
Participants receive either faecal microbial transplantation (FMT) or placebo transplantation to prevent recurrent urinary tract infections.
1 baseline visit and multiple follow-up visits during treatment
Duration - Up to 5 years
Participants are monitored to assess the long-term effectiveness and safety of the transplantation.
Periodic visits depending on participant status
Trial Site Locations
Total: 1 location
1
Meilahti Vaccine Research Center, Helsinki University Central Hospital
Helsinki, Finland, 00290
Actively Recruiting
Research Team
S
Sari Pakkanen, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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