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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lactizole-placebo | Active Comparator | A group of patients who will receive 3ml lactizole solution (150ppm) in nebulization twice a day for 4 weeks , and then for the next 4 weeks they will receive 2 times a day 3ml 0.9% NaCl solution in nebulization |
|
| placebo-lactizole | Active Comparator | A group of patients who will receive 2 times a day for 4 weeks (0.9% NaCl solution in nebulization) for 4 weeks and will receive 3ml of lactizole solution (150ppm) in nebulization 2 times a day for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lactizole nebulization | Dietary Supplement | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Pseudomonas aeruginosa abundance | 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) | Change from Baseline after 4 weeks of the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in cystic fibrosis symptoms | 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 after 4 weeks of the intervention |
| Change from Baseline in Lung function test |
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Inclusion Criteria:
Exclusion Criteria:
Temporary exclusion criteria
- acute respiratory infection within 2 weeks from 1, 2 and 3 visits of the study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paweł Majak | Contact | 600621878 | pmajak@o2.pl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Internal Medicine, Asthma and Allergy, Barlicki University Hospital, Medical University of Lodz, Lodz, Poland | Recruiting | Lodz | 90-153 | Poland |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Placebo | Other | 0.9% NaCl solution in nebulization |
|
Lung function test: spirometry will be performed in accordance with ERS / ATS standards |
| Change from Baseline after 4 weeks of the intervention |
| Change from Baseline in Taste perception | Taste perception testing (gustometry): quantitative evaluation using a standardized TSTs diagnostic tool (Taste Strips, Burghart, Wedel, Germany | Change from Baseline after 4 weeks of the intervention |
| Change from Baseline in Nasal ILC1, 2 and 3 cells | 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 after 4 weeks of the intervention |
| Change from Baseline in Nasal cytokines expression | 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) | Change from Baseline after 4 weeks of the intervention |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |