Curcumin Genistein trial in The Netherlands!!

Updated February 14th 2015

After we found out about the ex-vivo effect of Curcumin and Genistein on J's intestinal cells, the researcher immediately started working on preparations for a trial and trying to get funding for it.  Out of a few thousand applicants, our project was awarded a government grant and in September 2014.

It's called the TicTac trial, a trial to evaluate the efficacy of Curcumin and Genistein for S1251N patients. See info below.

So far 9 patients have completed the trial and 1 is still in it. There are still 2 or 3 patients interested in participating, but I'm not sure if they will participate once Kalydeco is available for them here in Holland. It's expected to be approved for insurance coverage next month.
Thankfully 10 patients is enough to prove statistical significance, if there is any.
I don't know any of the results so far. They keep telling me they will wait until all patients have finished the trial before they will process the results....

The waiting is difficult! Fingers crossed for positive results!


The effect of curcumin and genistein in CF patients with a class III mutation

- 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- ISRCTN	ISRCTN no longer applicable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
- ACRONYM	TICTAC
- 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; • Known cholelithiasis; • Inability to follow instructions of the investigator.
- MEC APPROVAL RECEIVED	no
- MULTICENTER TRIAL	yes
- RANDOMISED	no
- GROUP	[default]
- TYPE	Single arm
- STUDYTYPE	intervention
- 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 patient’s 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	planned
- CONTACT FOR PUBLIC QUERIES	S. Michel
- CONTACT FOR SCIENTIFIC QUERIES	G. Berkers
- SPONSOR/INITIATOR	University Medical Center Utrecht (UMCU)
- FUNDING (SOURCE(S) OF MONETARY OR MATERIAL SUPPORT)	ZON-MW, The Netherlands Organization for Health Research and Development
- PUBLICATIONS
- 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 patient’s 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 - 4-jul-2014

from here: http://www.trialregister.nl/Trialreg/admin/rctview.asp?TC=4585