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

University of Campania Luigi Vanvitelli52 enrolled

Overview

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 .

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Asthma

Interventions

Reuterin D3 dropsDRUG

5 drops/day for 3 months

PlaceboOTHER

5 drops/day for 3 months

Eligibility

Sex: ALLMin age: 6 YearsMax age: 14 Years

Medical Language ↔ Plain English

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

Locations (1)

Second University of Naples

Naples, Italy, Italy

Outcomes

Primary Outcomes

Reduction of allergic bronchial inflammation

Reduction of FeNO values

Time frame: Up to 3 months

Reduction of allergic bronchial inflammation

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

Time frame: Up to 3 months

Secondary Outcomes

Improvement of asthma control by C-ACT

Improvement in asthma control assessed by: C-ACT (Scores \> 19)

Time frame: Up to 3 months

Improvement of asthma control by reduction of bronchodilator

Improvement in asthma control assessed by: Reduction use of bronchodilator

Time frame: Up to 3 months

Improvement of asthma control by improvement of FEV-1

Improvement in asthma control assessed by: Improvement of Forced Expiratory Volume in 1 second (FEV-1)

Time frame: Up to 3 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.