Clinical trial NCT02745899: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma
Keywords: asthma
cow milk
pulmonary function testing
children
mucus
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-04-20
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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.

Primary outcomes:
measure: Cough and mucus production according to patient's report and physical examination
timeFrame: Baseline
measure: Cough and mucus production according to patient's report and physical examination
timeFrame: 30 minutes after the intervention
measure: Cough and mucus production according to patient's report and physical examination
timeFrame: 60 minutes after the intervention
measure: Cough and mucus production according to patient's report and physical examination
timeFrame: 90 minutes after the intervention
measure: Cough and mucus production according to patient's report and physical examination
timeFrame: 120 minutes after the intervention
Secondary outcomes:
measure: Fraction of exhaled Nitric Oxide (FeNO)
timeFrame: Baseline
measure: Fraction of exhaled Nitric Oxide (FeNO)
timeFrame: 30 minutes after the intervention
measure: Fraction of exhaled Nitric Oxide (FeNO)
timeFrame: 60 minutes after the intervention
measure: Fraction of exhaled Nitric Oxide (FeNO)
timeFrame: 90 minutes after the intervention
measure: Fraction of exhaled Nitric Oxide (FeNO)
timeFrame: 120 minutes after the intervention
measure: Spirometry - Forced expiratory flow 1 sec
timeFrame: Baseline
measure: Spirometry - Forced expiratory flow 1 sec
timeFrame: 30 minutes after the intervention
measure: Spirometry - Forced expiratory flow 1 sec
timeFrame: 60 minutes after the intervention
measure: Spirometry - Forced expiratory flow 1 sec
timeFrame: 90 minutes after the intervention
measure: Spirometry - Forced expiratory flow 1 sec
timeFrame: 120 minutes after the intervention
Other outcomes:
Locations:
Study officials:
affiliation: Department of Pediatric Pulmonology, Critical Care and Sleep Medicine Dana-Dwek Children's Hospital, Tel Aviv Sourasky Medical Center
name: Keren Armoni Domany, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
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.