The Effects of Taste Receptors Regulation in Upper Airway Innate Immunity of CF Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change from Baseline in Pseudomonas aeruginosa abundance
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ulmonary manifestations of cystic fibrosis
排除标准
- •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.
研究组 & 干预措施
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
干预措施: lactizole nebulization (Dietary Supplement)
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
干预措施: Placebo (Other)
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
干预措施: lactizole nebulization (Dietary Supplement)
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
干预措施: Placebo (Other)
结局指标
主要结局
Change from Baseline in Pseudomonas aeruginosa abundance
时间窗: 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)
次要结局
- Change from Baseline in Nasal cytokines expression(Change from Baseline after 4 weeks of the intervention)
- Change from Baseline in Taste perception(Change from Baseline after 4 weeks of the intervention)
- Change from Baseline in cystic fibrosis symptoms(Change from Baseline after 4 weeks of the intervention)
- Change from Baseline in Lung function test(Change from Baseline after 4 weeks of the intervention)
- Change from Baseline in Nasal ILC1, 2 and 3 cells(Change from Baseline after 4 weeks of the intervention)
研究者
Pawel Majak
Principal Investigator
Medical University of Lodz