Genistein as an add-on treatment for CF?

Phase 2

Completed

Conditions: Cystic Fibrosis
Mucoviscidosis
10038686
10010613

Registration Number: NL-OMON45929

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 14

Inclusion Criteria

*CFTR genotype associated with residual CFTR function;
*Already had a rectal biopsy to produce an organoid;
*Use of Ivacaftor;
*Male and female patients, aged 6 years or older on the date of informed consent;
*Signed informed consent form (IC).

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);
*(History of) hypothyroidism;
*Women who are trying to become pregnant or are pregnant or breastfeeding;
*Women with estrogen receptor-positive tumors;
*Postmenopausal women on tamoxifen therapy for estrogen-responsive breast cancer;
*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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is pulmonary function (Forced Expiratory volume in 1<br /><br>second; FEV1) measured before and after the use of genistein and before and<br /><br>after the use of placebo. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints to evaluate in vivo effect are:<br /><br>* Sweat chloride concentration (SCC)<br /><br>* Airway resistance (Rint and bodybox)<br /><br>* Body Mass Index (BMI)<br /><br>* Quality of life (measured with the Cystic Fibrosis Questionnnaire; (CFQ))<br /><br>* Elastase measurements in the feces<br /><br>* The CFTR stimulating ability of the concentration of genistein in the<br /><br>patient*s blood samples. We will also determine the plasma levels of genistein;<br /><br>Assessment of ß-adrenergic sweat secretion by evaporimetry is included as an<br /><br>exploratory endpoint. </p><br>