The Effect of Cow Milk Consumption on Respiratory Symptoms and Pulmonary Functions in Asthmatic and Non Asthmatic Children

Overview

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.

Full Title of Study: “The Effect of Cow-milk Consumption on Respiratory Symptoms and Pulmonary Functions in Asthmatic and Non-asthmatic Children”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Screening
    • Masking: Single (Investigator)
  • Study Primary Completion Date: May 2017

Detailed Description

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.

Interventions

  • Dietary Supplement: Cow milk
    • Ingestion of 240 ml cow milk
  • Dietary Supplement: Soy milk
    • Ingestion of 240 ml soy milk

Arms, Groups and Cohorts

  • Active Comparator: Soy milk substitute Healthy
    • Healthy children aged 6-18 will drink 240 ml of soy milk substitute.
  • Active Comparator: Soy milk substitute Asthma
    • Asthmatic children aged 6-18 will drink 240 ml of soy milk substitute.
  • Experimental: Cow milk Healthy
    • Healthy children aged 6-18 will drink 240 ml of cow milk.
  • Experimental: Cow milk Asthma
    • Asthmatic children aged 6-18 will drink 240 ml of cow milk.

Clinical Trial Outcome Measures

Primary Measures

  • Cough and mucus production according to patient’s report and physical examination
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
  • Cough and mucus production according to patient’s report and physical examination
    • Time Frame: 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

Secondary Measures

  • Fraction of exhaled Nitric Oxide (FeNO)
    • Time Frame: Baseline
    • single breath method: This test measures the concentration of NO in the exhaled air. In this method the patient takes a deep breath from the filter device and exhales the air at a constant rate of 50 mL / min for 12 seconds. The results of each test will be the average value of three tests. General measurement: overall system to be measured FENO device Denox 88 (ECO Medics AG, Switzerland), and nitric oxide 88 CLD analyzer which was approved for use by the FDA’s medical device approval if the Ministry of Health. The values are in parts per billion (Ppb). children aged 5-6 years are able to perform this test. FENO values: Low FENO: 0-5 ppb in Children Normal FENO: 5-20 ppb in children Mild elevated FENO:20-30 ppb in children High FENO: 30-70 ppb in Children Severe FENO: >70 ppb in Children
  • Fraction of exhaled Nitric Oxide (FeNO)
    • Time Frame: 30 minutes after the intervention
    • single breath method: This test measures the concentration of NO in the exhaled air. In this method the patient takes a deep breath from the filter device and exhales the air at a constant rate of 50 mL / min for 12 seconds. The results of each test will be the average value of three tests. General measurement: overall system to be measured FENO device Denox 88 (ECO Medics AG, Switzerland), and nitric oxide 88 CLD analyzer which was approved for use by the FDA’s medical device approval if the Ministry of Health. The values are in parts per billion (Ppb). children aged 5-6 years are able to perform this test. FENO values: Low FENO: 0-5 ppb in Children Normal FENO: 5-20 ppb in children Mild elevated FENO:20-30 ppb in children High FENO: 30-70 ppb in Children Severe FENO: >70 ppb in Children
  • Fraction of exhaled Nitric Oxide (FeNO)
    • Time Frame: 60 minutes after the intervention
    • single breath method: This test measures the concentration of NO in the exhaled air. In this method the patient takes a deep breath from the filter device and exhales the air at a constant rate of 50 mL / min for 12 seconds. The results of each test will be the average value of three tests. General measurement: overall system to be measured FENO device Denox 88 (ECO Medics AG, Switzerland), and nitric oxide 88 CLD analyzer which was approved for use by the FDA’s medical device approval if the Ministry of Health. The values are in parts per billion (Ppb). children aged 5-6 years are able to perform this test. FENO values: Low FENO: 0-5 ppb in Children Normal FENO: 5-20 ppb in children Mild elevated FENO:20-30 ppb in children High FENO: 30-70 ppb in Children Severe FENO: >70 ppb in Children
  • Fraction of exhaled Nitric Oxide (FeNO)
    • Time Frame: 90 minutes after the intervention
    • single breath method: This test measures the concentration of NO in the exhaled air. In this method the patient takes a deep breath from the filter device and exhales the air at a constant rate of 50 mL / min for 12 seconds. The results of each test will be the average value of three tests. General measurement: overall system to be measured FENO device Denox 88 (ECO Medics AG, Switzerland), and nitric oxide 88 CLD analyzer which was approved for use by the FDA’s medical device approval if the Ministry of Health. The values are in parts per billion (Ppb). children aged 5-6 years are able to perform this test. FENO values: Low FENO: 0-5 ppb in Children Normal FENO: 5-20 ppb in children Mild elevated FENO:20-30 ppb in children High FENO: 30-70 ppb in Children Severe FENO: >70 ppb in Children
  • Fraction of exhaled Nitric Oxide (FeNO)
    • Time Frame: 120 minutes after the intervention
    • single breath method: This test measures the concentration of NO in the exhaled air. In this method the patient takes a deep breath from the filter device and exhales the air at a constant rate of 50 mL / min for 12 seconds. The results of each test will be the average value of three tests. General measurement: overall system to be measured FENO device Denox 88 (ECO Medics AG, Switzerland), and nitric oxide 88 CLD analyzer which was approved for use by the FDA’s medical device approval if the Ministry of Health. The values are in parts per billion (Ppb). children aged 5-6 years are able to perform this test. FENO values: Low FENO: 0-5 ppb in Children Normal FENO: 5-20 ppb in children Mild elevated FENO:20-30 ppb in children High FENO: 30-70 ppb in Children Severe FENO: >70 ppb in Children
  • Spirometry – Forced expiratory flow 1 sec
    • Time Frame: Baseline
    • This test measures how much air is moved in and out of the lungs and how fast the air moves. the patient will be asked to take in a deep breath and to blow the air out into a filter that is connected to a computer. computer measures how much and how fast the air is blown out. Each test will be performed three times and the average value choice.Forced expiratory flow 1 sec (percent of predicted value) is the value that will be compared before and after the intervention.
  • Spirometry – Forced expiratory flow 1 sec
    • Time Frame: 30 minutes after the intervention
    • This test measures how much air is moved in and out of the lungs and how fast the air moves. the patient will be asked to take in a deep breath and to blow the air out into a filter that is connected to a computer. computer measures how much and how fast the air is blown out. Each test will be performed three times and the average value choice.Forced expiratory flow 1 sec (percent of predicted value) is the value that will be compared before and after the intervention.
  • Spirometry – Forced expiratory flow 1 sec
    • Time Frame: 60 minutes after the intervention
    • This test measures how much air is moved in and out of the lungs and how fast the air moves. the patient will be asked to take in a deep breath and to blow the air out into a filter that is connected to a computer. computer measures how much and how fast the air is blown out. Each test will be performed three times and the average value choice.Forced expiratory flow 1 sec (percent of predicted value) is the value that will be compared before and after the intervention.
  • Spirometry – Forced expiratory flow 1 sec
    • Time Frame: 90 minutes after the intervention
    • This test measures how much air is moved in and out of the lungs and how fast the air moves. the patient will be asked to take in a deep breath and to blow the air out into a filter that is connected to a computer. computer measures how much and how fast the air is blown out. Each test will be performed three times and the average value choice.Forced expiratory flow 1 sec (percent of predicted value) is the value that will be compared before and after the intervention.
  • Spirometry – Forced expiratory flow 1 sec
    • Time Frame: 120 minutes after the intervention
    • This test measures how much air is moved in and out of the lungs and how fast the air moves. the patient will be asked to take in a deep breath and to blow the air out into a filter that is connected to a computer. computer measures how much and how fast the air is blown out. Each test will be performed three times and the average value choice.Forced expiratory flow 1 sec (percent of predicted value) is the value that will be compared before and after the intervention.

Participating in This Clinical Trial

Inclusion Criteria

  • Healthy children – Asthmatic children Exclusion Criteria:

  • 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.

Gender Eligibility: All

Minimum Age: 6 Years

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Tel-Aviv Sourasky Medical Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Keren Armoni Domany, Doctor, Principal Investigator, Department of Pediatric Pulmonology, Critical Care and Sleep Medicine Dana-Dwek Children’s Hospital, Tel Aviv Sourasky Medical Center
  • Overall Contact(s)
    • Keren Armoni Domany, Doctor, +972-3-6974614, domany@gmail.com

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