Taste Receptors Regulation in CF Patients

NCT04058340 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-08-19

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Medical University of Lodz

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-30
Primary Completion
2019-11-30
Completion
2019-12-30

Countries

  • Poland

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04058340 on ClinicalTrials.gov