Taste Receptors Regulation in CF Patients (CFTaste)

The Effects of Taste Receptors Regulation in Upper Airway Innate Immunity of CF Patients

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.

Study Overview

• Status: Unknown
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Dietary supplement: lactizole nebulization; Other: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paweł Majak; Phone Number: 600621878; Email: pmajak@o2.pl

Study Locations

• Poland
  • Lodz, Poland, 90-153
    • Recruiting
    • Department of Internal Medicine, Asthma and Allergy, Barlicki University Hospital, Medical University of Lodz, Lodz, Poland
    • Contact: Pawel Majak, MD, PhD; Phone Number: +48 426776951; Email: pawel.majak@umed.lodz.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 exclusion criteria

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: lactizole-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	Dietary supplement: lactizole 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); Other: Placebo; 0.9% NaCl solution in nebulization
Active Comparator: placebo-lactizole; 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	Dietary supplement: lactizole 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); Other: Placebo; 0.9% NaCl solution in nebulization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Medical University of Lodz

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2019
• Primary Completion (Anticipated): November 30, 2019
• Study Completion (Anticipated): December 30, 2019

Study Registration Dates

• First Submitted: August 12, 2019
• First Submitted That Met QC Criteria: August 14, 2019
• First Posted (Actual): August 15, 2019

Study Record Updates

• Last Update Posted (Actual): August 19, 2019
• Last Update Submitted That Met QC Criteria: August 16, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Cystic Fibrosis
• Other Study ID Numbers: RNN/154/16/KE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No