Modification of dietary intake to influence the bladder microbiome
Summary description of the study
The study investigates whether a specific dietary change can reduce the occurrence of PAH-degrading bacteria in urine. This is a prospective, non-randomized study with 12 healthy volunteers (6 men, 6 women), each adhering to specific diets for 10 weeks. The primary aim is to determine whether a protective diet decreases the occurrence of these bacteria. Secondary aims include analyzing biomarkers in urine and examining the condition of cells in urine. It is expected that diet will influence these parameters. Participants must meet certain criteria, such as a specific BMI, being non-smokers, and being willing to provide urine and blood samples. Participants with certain exclusion criteria, such as pregnancy, chronic diseases, or vegetarian diets, will be excluded. Study participants will adhere to both a protective and a non-protective diet, provide biomarker samples over 10-week periods, and keep 3-day dietary records to verify adherence to the diets.
(BASEC)
Intervention under investigation
The study plans to include 12 healthy volunteers (six women and six men) who will follow a special diet for 10 weeks. After 10 weeks, analyses of urine and stool biomarkers will be conducted. We want to find out whether adherence to a specific protective diet affects the presence of PAH-degrading bacteria in urine, influences liquid biomarkers, and characterizes the cells excreted in urine.
(BASEC)
Disease under investigation
Healthy volunteers. The study investigates whether the presence of PAH-degrading bacteria can be influenced by dietary changes in healthy volunteers. PAH-degrading bacteria pose a risk for the development of bladder cancer. The study aims to investigate whether dietary changes can alter the presence of PAH-degrading bacteria.
(BASEC)
Age ≥ 18 years Body Mass Index (BMI) between 18.5 and 24.9 Alcohol consumption under 14 units per week (less than 2 units per day) Non-smokers (neither currently nor recently regularly smoked cigarettes) (BASEC)
Exclusion criteria
Known diagnosis or treatment of an eating disorder Antibiotic use 4 weeks prior to study participation Vegetarian or vegan diet (BASEC)
Trial sites
Other
(BASEC)
Biel
(BASEC)
Sponsor
Spitalzentrum Biel
(BASEC)
Contact
Contact Person Switzerland
Prof. med. R. Seiler-Blarer
+41 32 324 32 06
Roland.Seiler-Blarer@clutterszb-chb.chKlinik für Urologie des Spitalzentrum Biel
(BASEC)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Bern
(BASEC)
Date of authorisation
25.09.2024
(BASEC)
ICTRP Trial ID
NCT05643963 (ICTRP)
Official title (approved by ethics committee)
modifiCatiOn of fOod intaKe to influence the Equilibrium of the uRinary BLADDER (BASEC)
Academic title
ModifiCatiOn of FOod IntaKe to Influence the Equilibrium of the URinary BLADDER (ICTRP)
Public title
The COOKER-BLADDER Trial (ICTRP)
Disease under investigation
Diet, HealthyUrinary Bladder DiseasesOncogenesis (ICTRP)
Intervention under investigation
Other: Dietary regimens (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Prevention. Masking: Single (Participant). (ICTRP)
Inclusion/Exclusion criteria
Inclusion Criteria:
- no daily medication
- no ongoing medical treatment
Exclusion Criteria:
- Chronic disease
- Regular medication
- Not willing to follow diet instructions (ICTRP)
not available
Primary and secondary end points
Change in molecular profile of urothelial cells (ICTRP)
Change in multiplex cytokine levels in voided urine;DNA sequences in urinary microbiome;Change of BMI;Change of heart rate;Change of blood pressure;Change of health status (ICTRP)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
Roland Seiler, Prof., urology@szb-chb.ch, +41 32 324 32 06 (ICTRP)
Secondary trial IDs
SZB-URO-23-001 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT05643963 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available