Modification of dietary intake to influence the bladder microbiome
Descrizione riassuntiva dello studio
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)
Intervento studiato
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)
Malattie studiate
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)
Criteri di esclusione
Known diagnosis or treatment of an eating disorder Antibiotic use 4 weeks prior to study participation Vegetarian or vegan diet (BASEC)
Luogo dello studio
Altro
(BASEC)
Biel
(BASEC)
Sponsor
Spitalzentrum Biel
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Prof. med. R. Seiler-Blarer
+41 32 324 32 06
Roland.Seiler-Blarer@clutterszb-chb.chKlinik für Urologie des Spitalzentrum Biel
(BASEC)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Berna
(BASEC)
Data di approvazione del comitato etico
25.09.2024
(BASEC)
ID di studio ICTRP
NCT05643963 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
modifiCatiOn of fOod intaKe to influence the Equilibrium of the uRinary BLADDER (BASEC)
Titolo accademico
ModifiCatiOn of FOod IntaKe to Influence the Equilibrium of the URinary BLADDER (ICTRP)
Titolo pubblico
The COOKER-BLADDER Trial (ICTRP)
Malattie studiate
Diet, HealthyUrinary Bladder DiseasesOncogenesis (ICTRP)
Intervento studiato
Other: Dietary regimens (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Prevention. Masking: Single (Participant). (ICTRP)
Criteri di inclusione/esclusione
Inclusion Criteria:
- no daily medication
- no ongoing medical treatment
Exclusion Criteria:
- Chronic disease
- Regular medication
- Not willing to follow diet instructions (ICTRP)
non disponibile
Endpoint primari e secondari
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)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
Roland Seiler, Prof., urology@szb-chb.ch, +41 32 324 32 06 (ICTRP)
ID secondari
SZB-URO-23-001 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT05643963 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile