Taste Receptors Regulation in CF Patients

Not Applicable

• Conditions: Cystic Fibrosis
• Interventions: Dietary Supplement: lactizole nebulization; Other: Placebo

• Registration Number: NCT04058340
• Lead Sponsor: Medical University of Lodz

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.

Study Timeline

• Study Start: 2019-07-30
• Status Verified: 2019-08
• Study First Submitted: 2019-08-12
• Study First Submitted QC: 2019-08-14
• Study First Posted: 2019-08-15
• Last Update Submitted: 2019-08-16
• Last Update Posted: 2019-08-19
• Primary Completion: 2019-11-30
• Study Completion: 2019-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• ulmonary manifestations of cystic fibrosis

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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 exclusion criteria

• acute respiratory infection within 2 weeks from 1, 2 and 3 visits of the study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
lactizole-placebo	Placebo	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
lactizole-placebo	lactizole nebulization	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	Placebo	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
placebo-lactizole	lactizole nebulization	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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)
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

Trial Locations

Locations (1)

Department of Internal Medicine, Asthma and Allergy, Barlicki University Hospital, Medical University of Lodz, Lodz, Poland; 🇵🇱 Lodz, Poland