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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23234

Enrollment

Registered

2014-05-07

Start date

2014-07-01

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

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.

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Sweat chloride concentration (SCC) before and after treatment with curcumin and genistein.	—

Secondary

Measure	Time frame
• 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.	—

Measure

Time frame

• 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.

—

Contacts

Public ContactS. Michel

Wilhelmina Kinderziekenhuis Huispostnummer KH 01.419.0 Postbus 85090

s.michel-2@umcutrecht.nl+31 (0)88 75 537 25

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)