Genistein as an add-on treatment for CF?
Recruiting
- Conditions
- Cystic Fibrosis, Taaislijmziekte, CF
- Registration Number
- NL-OMON24579
- Lead Sponsor
- niversity Medical Center Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
· CFTR genotype: at least one S1251N mutation;
· Already had a rectal biopsy to produce an organoid;
Exclusion Criteria
· Use of genistein or curcumin at start or within four weeks prior to start of the study;
· Severe acute exacerbation or pulmonary infection during last four weeks (needing
intravenous treatment and/or systemic corticosteroids);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The main study parameter is pulmonary function (%FEV1) measured before and after the use<br>of genistein and before and after the use of placebo.
- Secondary Outcome Measures
Name Time Method · Sweat chloride concentration (SCC), before and after the use of genistein and placebo;<br /><br>· Airway resistance (Rint and bodybox), before and after the use of genistein and<br>placebo;<br /><br>· BMI (=weight (in Kg)/Length2 (in cm)) before and after the use of genistein and<br>placebo;<br /><br>· Quality of life (measured with CFQ-questionnaire) before and after the use of<br>genistein and placebo;<br /><br>· Elastase measurements in the feces before and after the use of genistein and placebo;<br /><br>· The CFTR stimulating ability of the concentration of genistein in the patient’s blood<br>samples, examined by in vitro testing (in the organoid model). We will also determine<br>the plasma levels of genistein by HPLC;<br><br /><br /><br>Exploratory endpoint:<br /><br>· Assessment of ß-adrenergic sweat secretion by evaporimetry, before and after<br>the use of genistein and placebo.<br />