Modification of dietary intake to influence the bladder microbiome
Zusammenfassung der Studie
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)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
Known diagnosis or treatment of an eating disorder Antibiotic use 4 weeks prior to study participation Vegetarian or vegan diet (BASEC)
Studienstandort
Andere
(BASEC)
Biel
(BASEC)
Sponsor
Spitalzentrum Biel
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Prof. med. R. Seiler-Blarer
+41 32 324 32 06
Roland.Seiler-Blarer@clutterszb-chb.chKlinik für Urologie des Spitalzentrum Biel
(BASEC)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Bern
(BASEC)
Datum der Bewilligung durch die Ethikkommission
25.09.2024
(BASEC)
ICTRP Studien-ID
NCT05643963 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
modifiCatiOn of fOod intaKe to influence the Equilibrium of the uRinary BLADDER (BASEC)
Wissenschaftlicher Titel
ModifiCatiOn of FOod IntaKe to Influence the Equilibrium of the URinary BLADDER (ICTRP)
Öffentlicher Titel
The COOKER-BLADDER Trial (ICTRP)
Untersuchte Krankheit(en)
Diet, HealthyUrinary Bladder DiseasesOncogenesis (ICTRP)
Untersuchte Intervention
Other: Dietary regimens (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Prevention. Masking: Single (Participant). (ICTRP)
Ein-/Ausschlusskriterien
Inclusion Criteria:
- no daily medication
- no ongoing medical treatment
Exclusion Criteria:
- Chronic disease
- Regular medication
- Not willing to follow diet instructions (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
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)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Roland Seiler, Prof., urology@szb-chb.ch, +41 32 324 32 06 (ICTRP)
Sekundäre IDs
SZB-URO-23-001 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT05643963 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar