Using non-pathogenic E.coli to prevent recurrent urinary tract infections
Bacterial Interference for Preventing Recurrent Urinary Tract Infection - New Ways of Treatment
This study is testing if a safe strain of E.coli can help prevent repeated urinary tract infections in people who often get them.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Odense University Hospital Academic / other |
| Locations | 2 sites (Aarhus N and 1 other locations) |
| Trial ID | NCT04846803 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of a non-pathogenic strain of E.coli to prevent recurrent urinary tract infections (rUTIs) in patients who have experienced multiple infections. The study employs a placebo-controlled, double-blind methodology to assess the effectiveness of bladder lavage with the non-pathogenic E.coli compared to saline. The aim is to provide an alternative treatment option that reduces reliance on antibiotics, which are commonly used for UTIs. The trial is conducted at Odense University Hospital and includes patients with a history of recurrent cystitis.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with recurrent cystitis, having experienced multiple UTIs within the past year, and who have not responded to previous treatments.
Not a fit: Patients with malignancies in the urinary tract, kidney or bladder stones, those under 18 years old, pregnant or breastfeeding women, and individuals currently on oral antibiotics may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the frequency of recurrent urinary tract infections and decrease antibiotic usage in affected patients.
How similar studies have performed: While the concept of bacterial interference is supported by laboratory studies, this specific clinical application is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosed with recurrent cystitis including 2 times of rUTI within the last 6 months or 3 times in the last 12 months, where at least 2 cultures show the same bacteria. * Normal investigation for lower urinary tract diseases (LUTD) including voiding diary, symptom scores, flexible cystoscopy, voiding diagram and test for residual urine. * Failed previously treatments. * Patients with native bladder with both spontaneous voiding, the need for clean intermittent catheter (CIC) or indwelling catheter. * Patients with neurogenic and non-neurogenic bladder dysfunction. * Patients with urostomy, kidney transplantation or another complicated genesis. * Written consent. Exclusion Criteria: * Malignancy in the urinary tract, kidney-, ureteral- or bladder stones, age \< 18 years, pregnancy, breastfeeding. Patients in ongoing orally antibiotic treatment. Not able to speak or understand Danish.
Where this trial is running
Aarhus N and 1 other locations
- Aarhus University Hospital — Aarhus N, Denmark (Recruiting)
- Odense University Hospital — Odense C, Denmark (Recruiting)
Study contacts
- Principal investigator: Karin Andersen — University of Southern Denmark
- Study coordinator: Karin Andersen, MD
- Email: karin.andersen@rsyd.dk
- Phone: +45 21570468
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.