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)

Journal of Immunology Research
Q1
Jan 2022
Citations:43
Influential Citations:0
Interventional (Human) Studies
86
S2 IconPDF Icon

Enhanced Details

Methods
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 422 children (212 active, 210 placebo).
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). Dosing: 1 sachet in the morning and 1 in the evening for eight weeks, then 1 sachet daily for a further eight weeks; powders dissolved in water or cold milk.
Results
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 potential as an adjunct to standard drug therapy.
Limitations
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.

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, a...