AsthmaNCT02745899
The Effect of Cow Milk Consumption on Respiratory Symptoms and Pulmonary Functions in Asthmatic and Non Asthmatic Children
A study testing Cow milk and Soy milk in people with Asthma, run by Tel-Aviv Sourasky Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Cow milk and Soy milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- May 2016to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy children
- Asthmatic children
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Asthma
- Being tested
- Cow milk, Soy milk
- Keywords
- asthma, cow milk, pulmonary function testing, children, mucus
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cow milkDietary supplement
Ingestion of 240 ml cow milk
Soy milkDietary supplement
Ingestion of 240 ml soy milk
| Study group | Role | What they receive |
|---|---|---|
| Soy milk substitute Healthy | Active comparator | Healthy children aged 6-18 will drink 240 ml of soy milk substitute. Receives: Dietary Supplement: Soy milk |
| Soy milk substitute Asthma | Active comparator | Asthmatic children aged 6-18 will drink 240 ml of soy milk substitute. Receives: Dietary Supplement: Soy milk |
| Cow milk Healthy | Experimental | Healthy children aged 6-18 will drink 240 ml of cow milk. Receives: Dietary Supplement: Cow milk |
| Cow milk Asthma | Experimental | Asthmatic children aged 6-18 will drink 240 ml of cow milk. Receives: Dietary Supplement: Cow milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 120 minutes after the intervention
Secondary outcomes (10)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 120 minutes after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02745899
- Sponsor's protocol ID
- TASMC-16-KA-0070-16-TLV-CTIL
- Status last verified
- May 2016
- First submitted
- 7 Feb 2016
- Last updated
- 3 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 32919454
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cow-milk Consumption on Respiratory Symptoms and Pulmonary Functions in Asthmatic and Non-asthmatic Children
- ClinicalTrials.gov ID
- NCT02745899
- Acronym / sponsor ID
- TASMC-16-KA-0070-16-TLV-CTIL
- Conditions
- Asthma
- Keywords
- asthma, cow milk, pulmonary function testing, children, mucus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- May 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 20 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Soy milk substitute Healthy | Active comparator | Dietary Supplement: Soy milkHealthy children aged 6-18 will drink 240 ml of soy milk substitute. |
| Soy milk substitute Asthma | Active comparator | Dietary Supplement: Soy milkAsthmatic children aged 6-18 will drink 240 ml of soy milk substitute. |
| Cow milk Healthy | Experimental | Dietary Supplement: Cow milkHealthy children aged 6-18 will drink 240 ml of cow milk. |
| Cow milk Asthma | Experimental | Dietary Supplement: Cow milkAsthmatic children aged 6-18 will drink 240 ml of cow milk. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Healthy children
- Asthmatic children
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cow milkIngestion of 240 ml cow milk | Dietary supplement | Cow milk Asthma, Cow milk Healthy |
| Soy milkIngestion of 240 ml soy milk | Dietary supplement | Soy milk substitute Asthma, Soy milk substitute Healthy |
Primary outcome
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
10 secondary outcomes
Fraction of exhaled Nitric Oxide (FeNO)
Time frame: Baseline
Fraction of exhaled Nitric Oxide (FeNO)
Time frame: 30 minutes after the intervention
Fraction of exhaled Nitric Oxide (FeNO)
Time frame: 60 minutes after the intervention
Fraction of exhaled Nitric Oxide (FeNO)
Time frame: 90 minutes after the intervention
Fraction of exhaled Nitric Oxide (FeNO)
Time frame: 120 minutes after the intervention
Spirometry - Forced expiratory flow 1 sec
Time frame: Baseline
Spirometry - Forced expiratory flow 1 sec
Time frame: 30 minutes after the intervention
Spirometry - Forced expiratory flow 1 sec
Time frame: 60 minutes after the intervention
Spirometry - Forced expiratory flow 1 sec
Time frame: 90 minutes after the intervention
Spirometry - Forced expiratory flow 1 sec
Time frame: 120 minutes after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2016.
- Derived from this study: PubMed 32919454Koren 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
Questions about this trial
What is this clinical trial studying?
A study testing Cow milk and Soy milk in people with Asthma, run by Tel-Aviv Sourasky Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Keren Armoni Domany, Doctor (+972-3-6974614, domany@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cough and mucus production according to patient's report and physical examination (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02745899, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2016.