Abstract
BACKGROUND: : Respiratory syncytial virus (RSV) and bacterial co-infections are primary cause of pneumonia. Recently, nasal-spraying Bacillus spore probiotics (LiveSpo NAVAX containing ≥ 5 billion/5mL B. subtilis and B. clausii spores) have demonstrated its effectiveness in supporting the treatment of acute respiratory tract infections caused by RSV and Influenza virus(1,2). METHODS: A randomized, double-blind, controlled clinical trial was conducted to evaluate the efficacy of LiveSpo NAVAX in the supportive treatment of severe pneumonia due to RSV and bacterial co-infections. A total of 120 eligible pediatric patients were randomly assigned to two groups: the Control group received 0.9% NaCl physiological saline, and the probiotic-intervention group (Navax group) received LiveSpo NAVAX three times a day. RESULTS: At day 3, the Navax group demonstrated significant reductions in both RSV and bacterial co-infection 15.7 and 40.8-fold greater than those observed in the control group. Notably, H. influenzae and S. pneumoniae were reduced by 22.8 and 17.2 folds, respectively. Additionally, the Navax group exhibited significant decreases in pro-inflammatory cytokines (IL-6, IL-8, TNF-α), with levels reduced by 1.4 - 3.6 folds, while also enhancing the immune system (IgA) by over 67.04%. Furthermore, the 16S rRNA metagenomic analysis revealed the restoration of nasal microbiota, with an increase in the density of beneficial genus such as Corynebacterium, Bacillus and a reduction in the density of harmful genus including Streptococcus, Haemophilus, and Moraxella. CONCLUSION: Our data demonstrate that nasal-spray Bacillus spore probiotics supported the treatment of pneumonia in children by reducing RSV, co-infection bacterial loads, and pro-inflammatory cytokines. DISCLOSURES: All Authors: No reported disclosures