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NCT Number: NCT02734446

To Evaluate the Efficacy of Supplementation With L. Reuteri + Vit. D3 in Asthmatic Children

The purpose of this project is to evaluate in a randomized clinical trial, double-blind, controlled, the effects of a dietary supplement containing Lactobacillus reuteri DSM 17938 and vitamin D3 in reducing bronchial inflammation and improve asthma control in patients in children with mild / moderate persistent asthma .

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Key information

Conditions

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

Age range

6 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Second University of Naples

Naples, Italy

About this study

To evaluate if the supplementation for three months with Lactobacillus reuteri DSM 17938 (108 CFU) + Vitamin D3 (400 IU) result in a reduction of the degree of allergic bronchial inflammation, measured with the Fractional exhaled nitric oxide (FeNO) and with a series of markers of bronchial inflammation (measured at 'beginning and at the end of the treatment on exhaled condensate): Interleukin 2(IL-2); Interleukin 4 (IL-4); Interleukin 10(IL-10); Interferon γ (IFN-γ).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged between 6 and 14 years old, of both sexes
  • Diagnosis of mild / moderate persistent asthma (GINA step 2/3)
  • Allergy mite (Dermatophagoides farinae and pteronyssinus + + + / + + + +)
  • Levels of vitamin 25 (OH) D <30 ng / ml
  • Signature of the informed consent of one parent or a legal representative

Exclusion criteria

  • Cardiovascular disease or systemic
  • anatomical abnormalities
  • Other respiratory diseases
  • Taking probiotics and / or prebiotics in the previous 2 weeks
  • Taking vitamin D or systemic corticosteroids within 4 weeks
  • Participation in other clinical trials

Treatment and study plan

Reuterin D3 drops

Drug

5 drops/day for 3 months

Other names: Lactobacillus reuteri DSM 17938 + Vit. D3

Placebo

Other

5 drops/day for 3 months

Primary outcomes

  1. Reduction of allergic bronchial inflammation

    Time frame: Up to 3 months

    Reduction of FeNO values

  2. Reduction of allergic bronchial inflammation

    Time frame: Up to 3 months

    Reduction of a series of markers of bronchial inflammation: IL-2; IL-4; IL-10; IFN-γ.

Secondary outcomes

  1. Improvement of asthma control by C-ACT

    Time frame: Up to 3 months

    Improvement in asthma control assessed by:

    C-ACT (Scores > 19)

  2. Improvement of asthma control by reduction of bronchodilator

    Time frame: Up to 3 months

    Improvement in asthma control assessed by:

    Reduction use of bronchodilator

  3. Improvement of asthma control by improvement of FEV-1

    Time frame: Up to 3 months

    Improvement in asthma control assessed by:

    Improvement of Forced Expiratory Volume in 1 second (FEV-1)

Sponsors and collaborators

Lead sponsor

University of Campania Luigi Vanvitelli

Other

Registry information

Official study title

Randomized Controlled Clinical Trial to Evaluate the Efficacy of Supplementation With L. Reuteri + Vit. D3 in Asthmatic Children

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Apr 12, 2016
Registry last updated
Apr 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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