|- candidate number||17691|
|- NTR Number||NTR4585|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||7-mei-2014|
|- Secondary IDs|| NL48122.041.14 |
|- Public Title||The effect of curcumin and genistein in CF patients with a class III mutation|
|- Scientific Title||The effect of curcumin and genistein in CF patients with a class III mutation|
|- hypothesis||Treatment with a combination of the natural food components curcumin and genistein can lead to a therapeutic level of restoration of the CFTR protein channel activity in patients with a class III, S1251N gating mutation.. Measurements in vitro can predict the individual treatment efficacy of curcumin and genistein.|
|- Healt Condition(s) or Problem(s) studied||Cystic Fibrosis (CF)|
|- Inclusion criteria|| CFTR genotype compound/ S1251N |
Had a rectal biopsy to produce an organoid
Male and female patients, aged 6 years or older on the date of informed consent or, where appropriate, date of assent
Signed informed consent form (IC), and where appropriate, signed assent form
|- Exclusion criteria|| Severe acute exacerbation or pulmonary infection during last four weeks (needing intravenous treatment and/or systemic corticosteroids); |
Use of curcumin and or genistein at start or within four weeks prior to start of the study.
Participation in another drug-investigating clinical study at the start or within four weeks prior to the start;
Inability to follow instructions of the investigator.
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-jul-2014|
|- planned closingdate||1-dec-2015|
|- Target number of participants||10|
|- Interventions||All patients will use the feeding supplements curcumin and genistein in a dosage that is based on their weight, during the first 8 weeks.|
|- Primary outcome||Sweat chloride concentration (SCC) before and after treatment with curcumin and genistein.|
|- Secondary outcome|| Correlation between individual curcumin+genistein induced CFTR function in vitro (organoid-based measurements) and in vivo treatment effect (lung function, SCC);|
The CFTR stimulating ability of the concentration of curcumin+genistein in the patients blood samples, examined by in vitro testing (in the organoid model). We will also determine the plasma levels of curcumin and genistein, only after treatment with curcumin and genistein.
Pulmonary function (%FEV1) and airway resistance (Rint and bodybox);
BMI (=weight (in Kg)/Length2 (in cm));
Quality of life (measured with CFQ-questionnaire);
Bile salt measurements in plasma and the feces;
Elastase measurements in the feces.
|- Timepoints||Before and after the use of curcumin+genistein |
|- Trial web site|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES|| S. Michel|
|- CONTACT for SCIENTIFIC QUERIES|| G. Berkers|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU)|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||We hypothesized that treatment with a combination of the natural food components curcumin and genistein can lead to a therapeutic level of restoration of the CFTR protein channel activity in patients with a class III, S1251N gating mutation.
Measurements in vitro (in organoids) can predict the individual treatment efficacy of curcumin and genistein. Primary objective is to investigate the therapeutic potential of the natural food components curcumin and genistein in Dutch CF patients carrying the S1251N gating mutation.
A secondary objective is to evaluate the correlations between individual curcumin+genistein induced CFTR function in vitro and the in vivo treatment effect. Another secondary objective is to evaluate the CFTR stimulating ability of the concentration of curcumin+genistein in the patients blood samples, examined by in vitro testing.Children, adolescents and adults with Cystic Fibrosis who are 6 years or older and have a compound/S1251N class III gating mutation will receive curcumin and genistein in a dosage that is based on their weight during 8 weeks.. Main study parameter will be sweat chloride concentrationbefore and after receiving curcumin+genistein.
|- Main changes (audit trail)|
|- RECORD||7-mei-2014 - 22-jun-2016|