Probiotics in Paediatric Asthma Management

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Controlled Double-blind Trial With Lactobacillus Salivarius LS01 (DSM 22775) and Bifidobacterium Breve B632 (DSM 24706) for Paediatric Asthma Management

Conditions
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Asthma in Children

Intervention / Treatment
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* Dietary Supplement: Bifiasthm
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled double-blind trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: probiotic treatment<br>For the first 8 weeks was administered 1 sachet in the morning and 1 in the evening, for the last 8 weeks was administered 1 sachet per day Lactobacillus salivarius LS01 (DSM 22775): 10^9 CFU Bifidobacterium breve B632 (DSM 24706): 10^9 CFU Maltodextrin and silicon dioxide | Dietary Supplement: Bifiasthm<br>* 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.<br>|
| Placebo Comparator: Placebo treatment<br>For the first 8 weeks was administered 1 sachet in the morning and 1 in the evening, for the last 8 weeks was administered 1 sachet per day Maltodextrin and silicon dioxide | Dietary Supplement: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Asthma episodes | Reduction in the frequency and severity of asthma crises, the evaluation is performed using Guidelines for management of Asthma, Italian Society of Pediatricians | 12 months | 
| Reduction in wheezing | Reduction in the frequency of wheezing episodes, numerical evaluation. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of adminstrated drug quantity | Reduction in the administered drug quantity for asthma crisis treatment | 12 months | 
| Reduction in treatment time | use of short-term treatments | 12 months |