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)

Study answer

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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Original abstract