Study to investigate bicarbonate excretion by the kidney in cystic fibrosis before and after a new treatment method using a simple drinking test
Descrizione riassuntiva dello studio
In cystic fibrosis, the kidney's ability to excrete bicarbonate ('baking soda') in urine is reduced to varying degrees. Bicarbonate is normally present in the body. For patients, this change has no impact, as bicarbonate is metabolized and excreted in other ways (e.g., through the lungs). In our research project, we want to find out whether it is possible to demonstrate the effectiveness of a (new) treatment method through a simple drinking test. This involves drinking a specific amount of liquid that contains tasteless bicarbonate ('baking soda') and subsequently measuring the amount of bicarbonate excreted in urine over several hours. This simple test, which does not require a blood draw, would be applied before and after the start of a (novel) treatment method to see if the kidney's ability to excrete bicarbonate improves with the (new) treatment method. This would provide a measurable, objective, and non-invasive way to demonstrate response to treatment, especially in patients with rarer mutations of cystic fibrosis. The research project aims to show whether this test meets expectations. The new treatment options have usually resulted in significant noticeable improvements in the disease for patients with common genetic forms of cystic fibrosis, which can also be measured and objectively documented using cumbersome methods. However, for the rarer genetic forms, it is important to have a simple test to determine whether the treatment is effective before the improvement is clearly noticeable to the patient.
(BASEC)
Intervento studiato
Drinking a predetermined amount of bicarbonate dissolved in water/syrup and subsequently measuring the amount of bicarbonate excreted in urine over 3 hours.
(BASEC)
Malattie studiate
Cystic Fibrosis (Mucoviscidosis)
(BASEC)
Confirmed diagnosis of cystic fibrosis (CF, mucoviscidosis) Known CF genotype Registered patient of the institution. At least 3 years old and able to urinate independently. Patients and/or parents of children have received and signed the patient information. Children have received an age-appropriate patient information document and consented to participate. (BASEC)
Criteri di esclusione
Intake of bicarbonate or 'alkaline diet' supplements before and during the test Fever over 38.0°C Discomfort Urinary tract infection Pregnancy (BASEC)
Luogo dello studio
Zurigo
(BASEC)
Sponsor
Pneumology University Childrens Hospital Zürich Lenggstrasse 8008 Zürich
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Alexander Möller
+41 44 266 72 03
alexander.moeller@clutterkispi.uzh.chPneumology University Childrens Hospital Zürich Lenggstrasse 8008 Zürich
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione etica Zurigo
(BASEC)
Data di approvazione del comitato etico
08.07.2025
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
Protocol Renal Bicarbonate Excretion in Cystic Fibrosis (BASEC)
Titolo accademico
non disponibile
Titolo pubblico
non disponibile
Malattie studiate
non disponibile
Intervento studiato
non disponibile
Tipo di studio
non disponibile
Disegno dello studio
non disponibile
Criteri di inclusione/esclusione
non disponibile
non disponibile
Endpoint primari e secondari
non disponibile
non disponibile
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
non disponibile
ID secondari
non disponibile
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
non disponibile
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile