Asthma in Children
Conditions
Brief summary
Randomized controlled double-blind trial in a child population with allergic asthma and recurring wheezing, undergoing probiotic treatment with Bifiasthm with the aim of assessing the reduction in asthma attacks.
Detailed description
Allergic disorders have dramatically increased in prevalence over the past decade, particularly in developed countries, and primary prevention of allergic disease has proved an elusive goal. There is increasing evidence that the airway microbiome influences the development of wheezing and childhood asthma. Probiotics are increasingly considered as a promising treatment for the correction of dysbiosis, reduction of systemic inflammation, and modulation of allergic diseases. The aim of this study is, therefore, to evaluate the efficacy of Bifidobacterium breve B632 (DSM 24706) and Lactobacillus salivarius LS01 (DSM 22775) in the prevention of asthmatic allergies in human subjects.
Interventions
DIETARY_SUPPLEMENTBifiasthm
Subjects will be instructed to take an active or placebo sachet twice daily for eight weeks, and subsequent intake of one dose daily for a further eight weeks.
DIETARY_SUPPLEMENTPlacebo
Placebo
Sponsors
Probiotical S.p.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Randomized controlled double-blind trial
Eligibility
Sex/Gender
ALL
Age
1 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
* The study will include all children aged 6 to 14, with slight and moderate persistent asthma according to GINA 2015 criteria (asthma classification did not change in GINA 2015 and 2016 guidelines), whether or not showing positive skin allergometric tests, as well as all children aged 2 yrs, 364 days to 5 years, 364 days, with recurring wheezing, whether or not diagnosed with asthma (positive and/or negative prick).
Exclusion criteria
* Severe persistent asthma * Known congenital or acquired immunodeficiencies * Cystic fibrosis * Chronic pulmonary diseases (bronchodysplasia) * Age \< 1 yr, 364d and 14 yrs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Asthma episodes | 12 months | Reduction in the frequency and severity of asthma crises, the evaluation is performed using Guidelines for management of Asthma, Italian Society of Pediatricians |
| Reduction in wheezing | 12 months | Reduction in the frequency of wheezing episodes, numerical evaluation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of adminstrated drug quantity | 12 months | Reduction in the administered drug quantity for asthma crisis treatment |
| Reduction in treatment time | 12 months | use of short-term treatments |
Countries
Italy
Outcome results
None listed