Using non-pathogenic E.coli to prevent recurrent urinary tract infections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.