Modification of dietary intake to influence the bladder microbiome
Résumé de l'étude
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 étudiée
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)
Maladie en cours d'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)
Critères d'exclusion
Known diagnosis or treatment of an eating disorder Antibiotic use 4 weeks prior to study participation Vegetarian or vegan diet (BASEC)
Lieu de l’étude
Autre
(BASEC)
Biel
(BASEC)
Sponsor
Spitalzentrum Biel
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Prof. med. R. Seiler-Blarer
+41 32 324 32 06
Roland.Seiler-Blarer@clutterszb-chb.chKlinik für Urologie des Spitalzentrum Biel
(BASEC)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique de Berne
(BASEC)
Date d'approbation du comité d'éthique
25.09.2024
(BASEC)
Identifiant de l'essai ICTRP
NCT05643963 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
modifiCatiOn of fOod intaKe to influence the Equilibrium of the uRinary BLADDER (BASEC)
Titre académique
ModifiCatiOn of FOod IntaKe to Influence the Equilibrium of the URinary BLADDER (ICTRP)
Titre public
The COOKER-BLADDER Trial (ICTRP)
Maladie en cours d'investigation
Diet, HealthyUrinary Bladder DiseasesOncogenesis (ICTRP)
Intervention étudiée
Other: Dietary regimens (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Prevention. Masking: Single (Participant). (ICTRP)
Critères d'inclusion/exclusion
Inclusion Criteria:
- no daily medication
- no ongoing medical treatment
Exclusion Criteria:
- Chronic disease
- Regular medication
- Not willing to follow diet instructions (ICTRP)
non disponible
Critères d'évaluation principaux et secondaires
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)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
non disponible
Contacts supplémentaires
Roland Seiler, Prof., urology@szb-chb.ch, +41 32 324 32 06 (ICTRP)
ID secondaires
SZB-URO-23-001 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT05643963 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible