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 NUMBER17691
NTR NUMBERNTR4585
- ISRCTNISRCTN no longer applicable
- DATE ISRCTN CREATED
- DATE ISRCTN REQUESTED
- DATE REGISTERED NTR7-mei-2014
- SECONDARY IDSNL48122.041.14 
- PUBLIC TITLEThe effect of curcumin and genistein in CF patients with a class III mutation
- SCIENTIFIC TITLEThe effect of curcumin and genistein in CF patients with a class III mutation
- ACRONYMTICTAC
- HYPOTHESISTreatment 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) STUDIEDCystic 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 RECEIVEDno
- MULTICENTER TRIALyes
- RANDOMISEDno
- GROUP[default]
- TYPESingle arm
- STUDYTYPEintervention
- PLANNED STARTDATE1-jul-2014
- PLANNED CLOSINGDATE1-dec-2015
- TARGET NUMBER OF PARTICIPANTS10
- INTERVENTIONSAll patients will use the feeding supplements curcumin and genistein in a dosage that is based on their weight, during the first 8 weeks.
- PRIMARY OUTCOMESweat 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.
- TIMEPOINTSBefore and after the use of curcumin+genistein
- TRIAL WEB SITE
- STATUSplanned
- CONTACT FOR PUBLIC QUERIESS. Michel
- CONTACT FOR SCIENTIFIC QUERIESG. Berkers
- SPONSOR/INITIATORUniversity Medical Center Utrecht (UMCU)
- FUNDING
(SOURCE(S) OF MONETARY OR MATERIAL SUPPORT)
ZON-MW, The Netherlands Organization for Health Research and Development
- PUBLICATIONS
- BRIEF SUMMARYWe 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)
- RECORD7-mei-2014 - 4-jul-2014


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

2 comments:

  1. Any updates? It's been a year since I see a post about this study.

    ReplyDelete
    Replies
    1. I wish I had an update for you, but I don't yet. It's nerve wrecking for me, that's for sure! It's out of my hands, I rely on what the trial coordinator tells me. As soon as I have any information, I'll share it on the blog!

      Delete