The Probiotics in Pediatric Asthma Management (PROPAM) Study in the Primary Care Setting: A Randomized, Controlled, Double-Blind Trial with Ligilactobacillus salivarius LS01 (DSM 22775) and Bifidobacterium breve B632 (DSM 24706)
What this study found
In the per-protocol population (n=422), 23.8% of placebo participants experienced at least one asthma exacerbation vs 9.0% in the probiotic group, and 8.1% vs 2.4% had two exacerbations. OR for at least one exacerbation = 3.17 (95% CI 1.80–5.60; p<0.001); OR for two or more exacerbations = 3.65 (95% CI 1.32–10.08; p=0.013). Exacerbation durations were similar (~3.3 days). The probiotic regimen was well tolerated with no clinically relevant adverse events. Authors conclude that L. salivarius LS01 and B. breve B632 are safe and significantly reduce asthma exacerbations in children, suggesting…
- Study & population
- Randomized, placebo-controlled, double-blind trial conducted by 11 Italian primary care pediatricians; participants were 500 children aged 3–14 years with asthma diagnosed according to GINA criteria; exclusions included severe asthma, congenital or acquired immunodeficiency, cystic fibrosis, and chronic pulmonary diseases; per-protocol analysis included…
- Intervention
- Probiotic mixture containing Ligilactobacillus salivarius LS01 (1×10^9 live cells) and Bifidobacterium breve B632 (1×10^9 live cells) per sachet (combined ≥2×10^9 live cells) or placebo (2 g maltodextrin).
- Key limitation
- Short-term study (16 weeks total) with no mechanistic analyses; some data were missing for certain variables; conducted in a specific Italian primary-care setting, limiting generalizability to other populations.
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Open PDFOriginal 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.