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

The Effect of Cow-milk Consumption on Respiratory Symptoms and Pulmonary Functions in Asthmatic and Non-asthmatic Children

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.

Study Overview

• Status: Unknown
• Conditions: Asthma
• Intervention / Treatment: Dietary supplement: Soy milk; Dietary supplement: Cow milk

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Soy milk substitute Healthy; Healthy children aged 6-18 will drink 240 ml of soy milk substitute.	Dietary supplement: Soy milk; Ingestion of 240 ml soy milk
Active Comparator: Soy milk substitute Asthma; Asthmatic children aged 6-18 will drink 240 ml of soy milk substitute.	Dietary supplement: Soy milk; Ingestion of 240 ml soy milk
Experimental: Cow milk Healthy; Healthy children aged 6-18 will drink 240 ml of cow milk.	Dietary supplement: Cow milk; Ingestion of 240 ml cow milk
Experimental: Cow milk Asthma; Asthmatic children aged 6-18 will drink 240 ml of cow milk.	Dietary supplement: Cow milk; Ingestion of 240 ml cow milk

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline
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	30 minutes after the intervention
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	60 minutes after the intervention
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	90 minutes after the intervention
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	120 minutes after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline
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	30 minutes after the intervention
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	60 minutes after the intervention
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	90 minutes after the intervention
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	120 minutes 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.	Baseline
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.	30 minutes 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.	60 minutes 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.	90 minutes 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.	120 minutes after the intervention

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center
• Investigators: Principal Investigator: Keren Armoni Domany, Doctor, Department of Pediatric Pulmonology, Critical Care and Sleep Medicine Dana-Dwek Children's Hospital, Tel Aviv Sourasky Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Anticipated): May 1, 2017
• Study Completion (Anticipated): May 1, 2017

Study Registration Dates

• First Submitted: February 7, 2016
• First Submitted That Met QC Criteria: April 19, 2016
• First Posted (Estimate): April 20, 2016

Study Record Updates

• Last Update Posted (Estimate): May 3, 2016
• Last Update Submitted That Met QC Criteria: May 1, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: children; asthma; pulmonary function testing; mucus; cow milk
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory
• Other Study ID Numbers: TASMC-16-KA-0070-16-TLV-CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No