Taste Receptors Regulation in CF Patients

NCT ID: NCT04058340

Last Updated: 2019-08-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-30
• Study Completion Date: 2019-12-30

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.

Conditions

Cystic Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

lactizole nebulization

Intervention Type: 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)

Placebo

Intervention Type: OTHER

0.9% NaCl solution in nebulization

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

Group Type: ACTIVE_COMPARATOR

lactizole nebulization

Intervention Type: 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)

Placebo

Intervention Type: OTHER

0.9% NaCl solution in nebulization

Interventions

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)

Intervention Type: DIETARY_SUPPLEMENT

Placebo

0.9% NaCl solution in nebulization

Intervention Type: OTHER

Eligibility Criteria

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.

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

• Minimum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Lodz

OTHER

Sponsor Role: lead

Responsible Party

Pawel Majak

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Lodz, , Poland

Site Status: RECRUITING

Countries

Poland

Central Contacts

Paweł Majak

Role: CONTACT

pmajak@o2.pl

600621878

Facility Contacts

Pawel Majak, MD, PhD

Role: primary

pawel.majak@umed.lodz.pl

+48 426776951

Other Identifiers

RNN/154/16/KE

Identifier Type: -

Identifier Source: org_study_id