The Effect of Cow-milk Consumption on Respiratory Symptoms and Pulmonary Functions in Asthmatic and Non-asthmatic Children
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 主要终点
- Cough and mucus production according to patient's report and physical examination
研究概览
简要总结
the investigators hypothesis is that milk consumption, either in the acute phase and through prolonged exposure, does not cause or increase respiratory symptoms or airway inflammation. the investigators aim to objectively prove this by examining respiratory symptoms and signs and objectively measuring parameters of airway inflammation and hyper responsiveness after consumption of cow milk or soy milk substitute.
详细描述
In this prospective single blinded placebo controlled trial, acute milk consumption will be evaluated. 50 asthmatic and 50 healthy children aged 6-18 will drink 240 ml of cow milk or soy milk substitute. Respiratory symptoms by questionnaire and physical examination will be evaluated. Airway response and inflammation will be assessed by fraction of exhaled Nitric Oxide (FENO) and spirometry before and after the exposure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy children
- •Asthmatic children
排除标准
- •Known allergy to cow milk
- •Children had upper / lower respiratory disease in two weeks prior the study.
- •Children who had been treated in systemic steroids in the month prior the study.
- •Intolerant children to cow milk.
研究组 & 干预措施
Cow milk Healthy
Healthy children aged 6-18 will drink 240 ml of cow milk.
干预措施: Cow milk (Dietary Supplement)
Cow milk Asthma
Asthmatic children aged 6-18 will drink 240 ml of cow milk.
干预措施: Cow milk (Dietary Supplement)
Soy milk substitute Healthy
Healthy children aged 6-18 will drink 240 ml of soy milk substitute.
干预措施: Soy milk (Dietary Supplement)
Soy milk substitute Asthma
Asthmatic children aged 6-18 will drink 240 ml of soy milk substitute.
干预措施: Soy milk (Dietary Supplement)
结局指标
主要结局
Cough and mucus production according to patient's report and physical examination
时间窗: 120 minutes after the intervention
subjective report by the parents including: appearance of cough, rhinitis and objective physical examinations signs including: wheezing, rales, cough- yes or no
Cough and mucus production according to patient's report and physical examination
时间窗: Baseline
subjective report by the parents including: appearance of cough, rhinitis and objective physical examinations signs including: wheezing, rales, cough- yes or no
Cough and mucus production according to patient's report and physical examination
时间窗: 30 minutes after the intervention
subjective report by the parents including: appearance of cough, rhinitis and objective physical examinations signs including: wheezing, rales, cough- yes or no
Cough and mucus production according to patient's report and physical examination
时间窗: 60 minutes after the intervention
subjective report by the parents including: appearance of cough, rhinitis and objective physical examinations signs including: wheezing, rales, cough- yes or no
Cough and mucus production according to patient's report and physical examination
时间窗: 90 minutes after the intervention
subjective report by the parents including: appearance of cough, rhinitis and objective physical examinations signs including: wheezing, rales, cough- yes or no
次要结局
- Spirometry - Forced expiratory flow 1 sec(120 minutes after the intervention)
- Fraction of exhaled Nitric Oxide (FeNO)(120 minutes after the intervention)
- Fraction of exhaled Nitric Oxide (FeNO)(Baseline)
- Fraction of exhaled Nitric Oxide (FeNO)(30 minutes after the intervention)
- Fraction of exhaled Nitric Oxide (FeNO)(60 minutes after the intervention)
- Fraction of exhaled Nitric Oxide (FeNO)(90 minutes after the intervention)
- Spirometry - Forced expiratory flow 1 sec(Baseline)
- Spirometry - Forced expiratory flow 1 sec(30 minutes after the intervention)
- Spirometry - Forced expiratory flow 1 sec(60 minutes after the intervention)
- Spirometry - Forced expiratory flow 1 sec(90 minutes after the intervention)