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

Tel Aviv Sourasky Medical Center

Status: Unknown

Conditions: Asthma

Treatments: Dietary Supplement: Soy milk; Dietary Supplement: Cow milk

Study type: Interventional

Funder types: Other

Identifiers

NCT02745899

TASMC-16-KA-0070-16-TLV-CTIL

Details and patient eligibility

About

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 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 6 to 18 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 4 patient groups

Soy milk substitute Healthy

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Soy milk

Soy milk substitute Asthma

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Soy milk

Cow milk Healthy

Experimental group

Description:

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

Treatment:

Dietary Supplement: Cow milk

Cow milk Asthma

Experimental group

Description:

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

Treatment:

Dietary Supplement: Cow milk