Abstract
Background Type-2 inflammation commonly marks asthma in childhood. Also, gut and lung dysbiosis is detectable in patients with asthma. Strain-related probiotic supplementation may restore a physiological immune response, dampen airway inflammation, and repair dysbiosis. Therefore, the probiotics in pediatric asthma management (PROPAM) study is aimed at demonstrating that Ligilactobacillus salivarius LS01 (DSM 22775) and Bifidobacterium breve B632 (DSM 24706) mixture could reduce asthma exacerbations in children, followed in a primary care setting. Methods The study was randomized, placebo-controlled, and double-blind. It involved 11 Italian primary care pediatricians. The probiotic mixture (containing Ligilactobacillus salivarius LS01 1 × 109 live cells and Bifidobacterium breve B632 1 × 109 live cells) or placebo was taken twice daily (1 sachet in the morning and 1 in the evening) for eight weeks and subsequently once daily for a further eight weeks. Outcomes included number, severity, and duration of asthma exacerbations, intensity of maintenance and as need treatments, and safety. Results The per-protocol population included 422 children (mean age seven years, 240 males and 182 females). The probiotic mixture significantly reduced the number of asthmatic exacerbations (OR = 3.17). In addition, the number of children with two exacerbations was less than a third in the active group (OR = 3.65). Conclusions This PROPAM study demonstrated that probiotic strains Ligilactobacillus salivarius LS01 (DSM 22775) and Bifidobacterium breve B632 (DSM 24706) were safe and significantly reduced by more than a third the frequency of asthma exacerbations. At present, the first-line treatment of asthma is still drug-based, but specific strains of probiotics may be auxiliary remedies.
Highlights
Asthma, including wheezing, represents a severe global health problem and a relevant burden for the healthcare system, as underscored by the 2021 Global Initiative for Asthma (GINA) guidelines
The variables included (i) the number of asthma exacerbations, severity, and duration documented by parents in a diary and assessed by clinicians at visits; (ii) the maintenance therapy, assessed by the intensity of treatment, scored as follows: no treatment, low intensity, medium intensity, high intensity, and (iii) the as-needed therapy during exacerbations, considering the use of oral corticosteroid and/or increase of inhaled corticosteroid dosage
The analyzed per-protocol (PP) population consisted of 422 children: 212 in the active arm and 210 in the placebo one
Summary
Type-2 inflammation commonly marks asthma in childhood. gut and lung dysbiosis is detectable in patients with asthma. The probiotics in pediatric asthma management (PROPAM) study is aimed at demonstrating that Ligilactobacillus salivarius LS01 (DSM 22775) and Bifidobacterium breve B632 (DSM 24706) mixture could reduce asthma exacerbations in children, followed in a primary care setting. The study was randomized, placebocontrolled, and double-blind. It involved 11 Italian primary care pediatricians. Severity, and duration of asthma exacerbations, intensity of maintenance and as need treatments, and safety. The probiotic mixture significantly reduced the number of asthmatic exacerbations (OR = 3:17). This PROPAM study demonstrated that probiotic strains Ligilactobacillus salivarius LS01 (DSM 22775) and Bifidobacterium breve B632 (DSM 24706) were safe and significantly reduced by more than a third the frequency of asthma exacerbations. The firstline treatment of asthma is still drug-based, but specific strains of probiotics may be auxiliary remedies
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