Using fecal microbiota transplantation to prevent recurrent urinary tract infections
Faecal Microbiota Transplantation as Means of Preventing Recurrent Urinary Tract Infections
This study is testing if a treatment using gut bacteria from healthy donors can help women who often get urinary tract infections to have fewer of them.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | Female |
| Sponsor | Helsinki University Central Hospital Academic / other |
| Locations | 1 site (Helsinki) |
| Trial ID | NCT06050148 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of fecal microbiota transplantation (FMT) as a method to prevent recurrent urinary tract infections (UTIs) in female patients. Participants will receive either FMT or a placebo to assess the effectiveness of this intervention against UTIs caused by both sensitive and ESBL-producing E. coli. The study aims to determine if altering gut microbiota can reduce the frequency of UTIs in individuals with a history of recurrent infections. Eligible participants must have experienced multiple UTIs within a specified timeframe and provide informed consent to participate.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 and older with a history of recurrent urinary tract infections.
Not a fit: Patients with gastrointestinal diseases, pregnancy, or those on immunosuppressive therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of recurrent urinary tract infections in women, improving their quality of life.
How similar studies have performed: Other studies have shown promise in using fecal microbiota transplantation for various conditions, but this specific application for recurrent UTIs is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Helsinki
- Meilahti Vaccine Research Center, Helsinki University Central Hospital — Helsinki, Finland (Recruiting)
Study contacts
- Study coordinator: Sari Pakkanen, PhD
- Email: vti-tutkimus@hus.fi
- Phone: +358 50 4482769
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.