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

Primary Purpose

Asthma

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cow milk
Soy milk
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Asthma focused on measuring asthma, cow milk, pulmonary function testing, children, mucus

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Experimental

    Experimental

    Arm Label

    Soy milk substitute Healthy

    Soy milk substitute Asthma

    Cow milk Healthy

    Cow milk Asthma

    Arm Description

    Healthy children aged 6-18 will drink 240 ml of soy milk substitute.

    Asthmatic children aged 6-18 will drink 240 ml of soy milk substitute.

    Healthy children aged 6-18 will drink 240 ml of cow milk.

    Asthmatic children aged 6-18 will drink 240 ml of cow milk.

    Outcomes

    Primary Outcome Measures

    Cough and mucus production according to patient's report and physical examination
    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
    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
    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
    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
    subjective report by the parents including: appearance of cough, rhinitis and objective physical examinations signs including: wheezing, rales, cough- yes or no

    Secondary Outcome Measures

    Fraction of exhaled Nitric Oxide (FeNO)
    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)
    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)
    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)
    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)
    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
    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
    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
    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
    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
    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.

    Full Information

    First Posted
    February 7, 2016
    Last Updated
    May 1, 2016
    Sponsor
    Tel-Aviv Sourasky Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02745899
    Brief Title
    The Effect of Cow Milk Consumption on Respiratory Symptoms and Pulmonary Functions in Asthmatic and Non Asthmatic Children
    Official Title
    The Effect of Cow-milk Consumption on Respiratory Symptoms and Pulmonary Functions in Asthmatic and Non-asthmatic Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2016 (undefined)
    Primary Completion Date
    May 2017 (Anticipated)
    Study Completion Date
    May 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Tel-Aviv Sourasky Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma
    Keywords
    asthma, cow milk, pulmonary function testing, children, mucus

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Soy milk substitute Healthy
    Arm Type
    Active Comparator
    Arm Description
    Healthy children aged 6-18 will drink 240 ml of soy milk substitute.
    Arm Title
    Soy milk substitute Asthma
    Arm Type
    Active Comparator
    Arm Description
    Asthmatic children aged 6-18 will drink 240 ml of soy milk substitute.
    Arm Title
    Cow milk Healthy
    Arm Type
    Experimental
    Arm Description
    Healthy children aged 6-18 will drink 240 ml of cow milk.
    Arm Title
    Cow milk Asthma
    Arm Type
    Experimental
    Arm Description
    Asthmatic children aged 6-18 will drink 240 ml of cow milk.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Cow milk
    Intervention Description
    Ingestion of 240 ml cow milk
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Soy milk
    Intervention Description
    Ingestion of 240 ml soy milk
    Primary Outcome Measure Information:
    Title
    Cough and mucus production according to patient's report and physical examination
    Description
    subjective report by the parents including: appearance of cough, rhinitis and objective physical examinations signs including: wheezing, rales, cough- yes or no
    Time Frame
    Baseline
    Title
    Cough and mucus production according to patient's report and physical examination
    Description
    subjective report by the parents including: appearance of cough, rhinitis and objective physical examinations signs including: wheezing, rales, cough- yes or no
    Time Frame
    30 minutes after the intervention
    Title
    Cough and mucus production according to patient's report and physical examination
    Description
    subjective report by the parents including: appearance of cough, rhinitis and objective physical examinations signs including: wheezing, rales, cough- yes or no
    Time Frame
    60 minutes after the intervention
    Title
    Cough and mucus production according to patient's report and physical examination
    Description
    subjective report by the parents including: appearance of cough, rhinitis and objective physical examinations signs including: wheezing, rales, cough- yes or no
    Time Frame
    90 minutes after the intervention
    Title
    Cough and mucus production according to patient's report and physical examination
    Description
    subjective report by the parents including: appearance of cough, rhinitis and objective physical examinations signs including: wheezing, rales, cough- yes or no
    Time Frame
    120 minutes after the intervention
    Secondary Outcome Measure Information:
    Title
    Fraction of exhaled Nitric Oxide (FeNO)
    Description
    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
    Time Frame
    Baseline
    Title
    Fraction of exhaled Nitric Oxide (FeNO)
    Description
    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
    Time Frame
    30 minutes after the intervention
    Title
    Fraction of exhaled Nitric Oxide (FeNO)
    Description
    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
    Time Frame
    60 minutes after the intervention
    Title
    Fraction of exhaled Nitric Oxide (FeNO)
    Description
    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
    Time Frame
    90 minutes after the intervention
    Title
    Fraction of exhaled Nitric Oxide (FeNO)
    Description
    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
    Time Frame
    120 minutes after the intervention
    Title
    Spirometry - Forced expiratory flow 1 sec
    Description
    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.
    Time Frame
    Baseline
    Title
    Spirometry - Forced expiratory flow 1 sec
    Description
    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.
    Time Frame
    30 minutes after the intervention
    Title
    Spirometry - Forced expiratory flow 1 sec
    Description
    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.
    Time Frame
    60 minutes after the intervention
    Title
    Spirometry - Forced expiratory flow 1 sec
    Description
    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.
    Time Frame
    90 minutes after the intervention
    Title
    Spirometry - Forced expiratory flow 1 sec
    Description
    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.
    Time Frame
    120 minutes after the intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Keren Armoni Domany, Doctor
    Phone
    +972-3-6974614
    Email
    domany@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Keren Armoni Domany, Doctor
    Organizational Affiliation
    Department of Pediatric Pulmonology, Critical Care and Sleep Medicine Dana-Dwek Children's Hospital, Tel Aviv Sourasky Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32919454
    Citation
    Koren Y, Armoni Domany K, Gut G, Hadanny A, Benor S, Tavor O, Sivan Y. Respiratory effects of acute milk consumption among asthmatic and non-asthmatic children: a randomized controlled study. BMC Pediatr. 2020 Sep 12;20(1):433. doi: 10.1186/s12887-020-02319-y.
    Results Reference
    derived

    Learn more about this trial

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

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