NCT04058340

Taste Receptors Regulation in CF Patients

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Medical University of Lodz · Academic / Other
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-07-30
• Primary completion: 2019-11-30
• Completion: 2019-12-30
• First posted: 2019-08-15
• Last updated: 2019-08-19

Locations

1 site across 1 country: Poland