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

Study Overview
=================
Brief Summary
-----------------
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 .

Detailed Description
-----------------
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).

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

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Reuterin D3 drops
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 14 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Reuterin D3 drops<br>Lactobacillus reuteri DSM 17938 (108 CFU) + Vitamin D3 (400 IU) 5 drops/day for 3 months (Reuterin D3 drops) | Drug: Reuterin D3 drops<br>* 5 drops/day for 3 months<br>* Other names: Lactobacillus reuteri DSM 17938 + Vit. D3;|
| Placebo Comparator: Placebo<br>The patients will receive 5 drops/day of placebo for 3 months | Other: Placebo<br>* 5 drops/day for 3 months<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of allergic bronchial inflammation | Reduction of FeNO values | 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. | Up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of asthma control by C-ACT | Improvement in asthma control assessed by: C-ACT (Scores > 19) | Up to 3 months | 
| Improvement of asthma control by reduction of bronchodilator | Improvement in asthma control assessed by: Reduction use of bronchodilator | 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) | Up to 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma Exacerbations, Bronchial Inflammation, Asthma, Childhood Asthma Control Test (C-ACT)