NCT04846803 Bacterial Interference for Preventing Recurrent Urinary Tract Infection - New Ways of Treatment
| NCT ID | NCT04846803 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Odense University Hospital |
| Condition | Recurrent Urinary Tract Infections |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-01-09 |
| Primary Completion | 2026-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2024-01-09 with a primary completion date of 2026-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Urinary tract infection (UTI) is one of the most common bacterial infections worldwide. It affects 150 million people annually. Treatment of patients with UTI entails a high consumption of antibiotics and large social and health costs. With this protocol, we want to elucidate alternative treatment methods for especially recurrent urinary tract infection. Bacteria have internal competitiveness (bacterial interference) and it is known that the non-pathogenic E.coli can outcompete the pathogenic E.coli in laboratory studies. We intend to strengthen the clinical evidence that it can be used as patient treatment through a clinical, placebo-controlled, double-blind trial at Odense University Hospital.
Eligibility 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.
Contact & Investigator
Karin Andersen
PRINCIPAL INVESTIGATOR
University of Southern Denmark
Frequently Asked Questions
Who can join the NCT04846803 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Recurrent Urinary Tract Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04846803 currently recruiting?
Yes, NCT04846803 is actively recruiting participants. Contact the research team at karin.andersen@rsyd.dk for enrollment information.
Where is the NCT04846803 trial being conducted?
This trial is being conducted at Aarhus N, Denmark, Odense C, Denmark.
Who is sponsoring the NCT04846803 clinical trial?
NCT04846803 is sponsored by Odense University Hospital. The principal investigator is Karin Andersen at University of Southern Denmark. The trial plans to enroll 80 participants.