(Recurrent) Urinary Tract Infections / (Recidiverende) Urineweginfecties Cystitis / Cystitis Quality of Life / Levenskwaliteit  
Conditions
Interventions
In this two-armed clinical trial, participants will be randomized (1:1) to either Winclove CLEAR or matching placebo.
- Active treatment: Participants (N = 20) consume a daily dose of 4g of Winclove
Sponsors
This study is performed at the research facility of CR2O by Prof. Dr. Eric Claassen (Principal Investigator) and Drs. Joost Flach (Coordinating Investigator).
Eligibility
Inclusion criteria
Inclusion criteria: In order to be eligible for inclusion, a subject must meet all of the following criteria: 1. rUTI* for at least 2 years (defined as 3 or more episodes of UTI per year). 2. At least 3 UTIs in the preceding 12 months. 3. Aged between 18 and 70 years. 4. Willing to take probiotics and refrain from UTI prophylaxis during the study. 5. Signed informed consent. * (Recurrent) Urinary Tract Infections
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: 1. Current (complicated) suspected UTI or cystitis 2. Prophylactic antibiotic usage during the intervention period 3. Probiotic, D-mannose or cranberry extract usage during the intervention period 4. Use of UTI prophylactics/treatments during the intervention period, other than mentioned under point 2 & 3, which in the opinion of the investigator may significantly interfere with the evaluation of the study objectives, including: estrogen treatment, immunoprophylaxis, methenamine Hippurate, ascorbic acid supplementation, acupuncture, UTI specific vaccines and endovesical instillation (of hyaluronic acid and chondroitin sulphate)*. 5. Concurrently enrolled in another intervention study (observational studies or inclusion following completion of another study is allowed (4-week wash-out)) 6. Known to have interstitial cystitis or bladder pain syndrome 7. Known to have a complex bladder disturbance (e.g. cystoplasty, renal and bladder calculus, significant hydronephrosis or current pyelonephritis) 8. Known to have severe renal or hepatic failure 9. Known to be severely or terminally ill 10. Known to have non-resolvable urinary obstruction 11. Known to have a history of adverse drug reaction to yoghurt or milk products or a demonstrated intolerance to the probiotics used - lactose intolerance is NOT an exclusion criterion 12. Known to be intolerant or allergic to any of the ingredients in both Winclove CLEAR and matched placebo 13. Spinal cord injury with suprapubic permanent catheter 14. Requiring full (invasive) mechanical ventilation 15. Receiving immunosuppressant medications or having an underlying immunosuppressive disease (e.g. HIV, end-stage / progressive diabetes mellitus, multiple sclerosis or cerebrovascular disease) 16. Planned oral/vaginal/urinary tract/bladder/gastrointestinal surgery during the intervention period 17. Recent oral/vaginal/urinary tract/bladder surgery/gastrointestinal (within last 3 months) 18. Pregnant females (screened with a positive pregnancy test), lactating or intending to become pregnant during the study. Women of childbearing potential need to use contraceptives 19. Use of intravaginal products (e.g. spermicides) except for menstrual products. 20. Any other condition, which, in the opinion of the investigator, may significantly interfere with the evaluation of the study objectives
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The differences in QoL between treatment arms according to UTI-QoL-questionnaire data and SF-36 scores after the intervention period. 2. The difference in UTI incidence between treatment arms, as measured by the mean number of patient-reported UTI episodes during the intervention period. 3. The difference in UTI symptom severity between treatment arms, as measured by mean Symptom & Burden questionnaire scores during the intervention period. | — |
Secondary
| Measure | Time frame |
|---|---|
| 4. The difference in UTI incidence between treatment arms, as confirmed by a microbiome analysis of urine samples during the intervention period (ratio of lactobacilli to common uropathogens). 5. The difference between treatment arms in UTI-related health-care expenditures during the intervention period, as determined by the Health Economics questionnaire at day 180. 6. The total number of subjects in the active treatment arm, and the difference on the number of subjects between treatment arms, where probiotic strains from the formulation are identified in urine samples at day 1, 60, 120 and 180 as determined by a primary species-specific 16S ribosomal RNA sequencing analysis and – if positive – a follow-up strain- specific real-time quantitative 16S ribosomal RNA gene polymerase chain reactions. 7. The difference in UTI duration between treatment arms, as determined by mean patient-reported UTI duration during the intervention period. Additionally, the difference delta (∆) from baseline will be compared between treatment arms for all previously mentioned outcome parameters. | — |
Contacts
Public ContactJ. Flach
CR2O
Outcome results
None listed