Cystic Fibrosis
Conditions
Brief summary
The project is intended to be realised in two phases. In the first stage, a case control study will be performed. In the second phase, double-blind, placebo controlled cross-over study will be conducted. The first stage it to compare innate immunity activation and Pseudomonas aeruginosa (Pa) expression between Pa positive and negative patients. In the second phase the effects of inhaled lactizole- TAS3R inhibitor will be assessed.
Detailed description
Three visits have been planned during the entire study. During the first visit, all patients included in the study will have the following procedures: questionnaire tests, lung function tests, taste perception tests (gustometry) and exfoliative cytology of the nasal mucosa. Patients with confirmed Pseudomonas aeruginosa presence in the airways will be randomly assigned to the Lactizole-Placebo group and the Placebo-Lactizole group, with a recommendation to take laktizol (3 ml) for 3 weeks at the concentration determined during the preliminary examination, in the nebulization 2 times per day) or placebo (3ml 0.9% NaCl solution in nebulization 2 once a day). The first nebulization of the solution issued during the visit will take place during the visit; each patient will undergo a clinical and spirometric assessment after 20 minutes of observation from completed nebulization. During the second visit (after 4 weeks from visit 1), the first visit procedures will be repeated for all patients. Patients in the Lactizole-Placebo group will be recommended to take a placebo for 4 weeks (3 ml of 0.9% NaCl solution in nebulization 2 once a day); on the other hand, patients from the Placebo-Lactizole group will be advised to take lactisol for 4 weeks (3 ml of the solution in the concentration determined during the preliminary examination, in the nebulization 2 once a day). The first nebulization of the solution issued during the visit will take place during the visit; each patient will undergo a clinical and spirometric assessment after 20 minutes of observation from completed nebulization. During the third visit (after 4 weeks from visit 2), the first visit procedures will be repeated for all patients.
Interventions
DIETARY_SUPPLEMENTlactizole nebulization
Lactizole is generally recognized as safe: GRAS Flavor and Extract Manufacturers Association ( numer: 3773 ) Lactizole solution for nebulization was calculated based on dose-response curves; 150ppm was chosen as minimal effective (decreased sweet taste perception) and safety ( lack of FEV1 changes after nebulization)
OTHERPlacebo
0.9% NaCl solution in nebulization
Sponsors
Medical University of Lodz
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ulmonary manifestations of cystic fibrosis
Exclusion criteria
* first positive result of inoculation from the airways, which according to the standard is associated with the need for antibiotic therapy * contraindication to a biopsy of the nasal mucosa * exacerbation requiring antibiotics * diabetes, exposure to tobacco smoke * other chronic diseases and clinical conditions which, according to the researcher, may influence the assessed parameters and the course of the study. Temporary
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Pseudomonas aeruginosa abundance | Change from Baseline after 4 weeks of the intervention | Decrease of abundance of P. aeruginosa in throat swabs after nebulized lactizole . intervention. PCR testing for the presence of Pseudomonas aeruginosa genetic material (FTD Bacterial pneumoniae-HAP, Fast-track diagnostics Ltd., Malta) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in cystic fibrosis symptoms | Change from Baseline after 4 weeks of the intervention | Questionnaire (standardized questionnaire to assess the degree of control of cystic fibrosis symptoms). Polish version of the Cystic Fibrosis Quality of Life Questionnaire (CFQoL) will be used |
| Change from Baseline in Lung function test | Change from Baseline after 4 weeks of the intervention | Lung function test: spirometry will be performed in accordance with ERS / ATS standards |
| Change from Baseline in Taste perception | Change from Baseline after 4 weeks of the intervention | Taste perception testing (gustometry): quantitative evaluation using a standardized TSTs diagnostic tool (Taste Strips, Burghart, Wedel, Germany |
| Change from Baseline in Nasal ILC1, 2 and 3 cells | Change from Baseline after 4 weeks of the intervention | Nasal mucosa samples (Rhino-probe, ASI, Arlington, Texas). The assessment of the nasal mucosa material will include: percentage of ILC1, 2 and 3 cells (immunophenotyping and measurement by flow cytometry) |
| Change from Baseline in Nasal cytokines expression | Change from Baseline after 4 weeks of the intervention | Nasal mucosa samples (Rhino-probe, ASI, Arlington, Texas). The assessment of the nasal mucosa material will include: mRNA expression for: Muc5b, Muc5ac, Beta-defensine, T1R3, T2Rs, selected cytokines (qPCR technique using self-designed primers) |
Countries
Poland
Contacts
Primary ContactPaweł Majak
Outcome results
None listed