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

NCT02745899 | Unknown

• 1 other identifier: TASMC-16-KA-0070-16-TLV-CTIL
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Asthma

Keywords

asthma; cow milk; pulmonary function testing; children; mucus

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (10)

• Fraction of exhaled Nitric Oxide (FeNO)

  Baseline

• Fraction of exhaled Nitric Oxide (FeNO)

  30 minutes after the intervention

• Fraction of exhaled Nitric Oxide (FeNO)

  60 minutes after the intervention

• Fraction of exhaled Nitric Oxide (FeNO)

  90 minutes after the intervention

• Fraction of exhaled Nitric Oxide (FeNO)

  120 minutes after the intervention

Study Arms (4)

Soy milk substitute Healthy

ACTIVE COMPARATOR

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

Dietary Supplement: Soy milk

Soy milk substitute Asthma

ACTIVE COMPARATOR

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

Dietary Supplement: Soy milk

Cow milk Healthy

EXPERIMENTAL

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

Dietary Supplement: Cow milk

Cow milk Asthma

EXPERIMENTAL

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

Dietary Supplement: Cow milk

Interventions

Cow milk DIETARY_SUPPLEMENT

Ingestion of 240 ml cow milk

Cow milk Asthma; Cow milk Healthy

Soy milk DIETARY_SUPPLEMENT

Ingestion of 240 ml soy milk

Soy milk substitute Asthma; Soy milk substitute Healthy

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Healthy children
• Asthmatic children

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Related Publications (1)

• 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.

  PMID: 32919454 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Milk; Soy Milk

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages; Milk Substitutes; Soy Foods; Vegetable Products; Vegetables

Study Officials

• Keren Armoni Domany, Doctor

  Department of Pediatric Pulmonology, Critical Care and Sleep Medicine Dana-Dwek Children's Hospital, Tel Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Keren Armoni Domany, Doctor

CONTACT

+972-3-6974614; domany@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2016
• First Posted: April 20, 2016
• Study Start: May 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: May 3, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share