Study to investigate bicarbonate excretion by the kidney in cystic fibrosis before and after a new treatment method using a simple drinking test
Résumé de l'étude
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)
Intervention étudiée
Drinking a predetermined amount of bicarbonate dissolved in water/syrup and subsequently measuring the amount of bicarbonate excreted in urine over 3 hours.
(BASEC)
Maladie en cours d'investigation
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)
Critères d'exclusion
Intake of bicarbonate or 'alkaline diet' supplements before and during the test Fever over 38.0°C Discomfort Urinary tract infection Pregnancy (BASEC)
Lieu de l’étude
Zurich
(BASEC)
Sponsor
Pneumology University Childrens Hospital Zürich Lenggstrasse 8008 Zürich
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Alexander Möller
+41 44 266 72 03
alexander.moeller@clutterkispi.uzh.chPneumology University Childrens Hospital Zürich Lenggstrasse 8008 Zürich
(BASEC)
Informations scientifiques
non disponible
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale de Zurich
(BASEC)
Date d'approbation du comité d'éthique
08.07.2025
(BASEC)
Identifiant de l'essai ICTRP
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Titre officiel (approuvé par le comité d'éthique)
Protocol Renal Bicarbonate Excretion in Cystic Fibrosis (BASEC)
Titre académique
non disponible
Titre public
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Maladie en cours d'investigation
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Intervention étudiée
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Type d'essai
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Plan de l'étude
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Critères d'inclusion/exclusion
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Critères d'évaluation principaux et secondaires
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Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
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ID secondaires
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Résultats-Données individuelles des participants
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Informations complémentaires sur l'essai
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Résultats de l'essai
Résumé des résultats
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Lien vers les résultats dans le registre primaire
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