Asthma
Conditions
Keywords
Bronchial Inflammation, Asthma, Childhood Asthma Control Test (C-ACT), Asthma Exacerbations
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).
Interventions
DRUGReuterin D3 drops
5 drops/day for 3 months
OTHERPlacebo
5 drops/day for 3 months
Sponsors
University of Campania Luigi Vanvitelli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to 14 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of allergic bronchial inflammation | Up to 3 months | Reduction of FeNO values |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of asthma control by improvement of FEV-1 | Up to 3 months | Improvement in asthma control assessed by: Improvement of Forced Expiratory Volume in 1 second (FEV-1) |
| Improvement of asthma control by C-ACT | Up to 3 months | Improvement in asthma control assessed by: C-ACT (Scores \> 19) |
| Improvement of asthma control by reduction of bronchodilator | Up to 3 months | Improvement in asthma control assessed by: Reduction use of bronchodilator |
Countries
Italy
Outcome results
None listed