Nasal-spraying Bacillus spore probiotics for pneumonia in children with respiratory syncytial virus and bacterial co-infections: a randomized clinical trial.

BACKGROUND: Our study addresses the pressing need for safe and effective treatments for pneumonia in young children caused by respiratory syncytial virus (RSV) and bacterial co-infections. This issue is particularly urgent given the absence of targeted RSV therapies and the growing threat of antibiotic resistance associated with managing bacterial co-infections. METHODS: We conducted a double-blind, randomized clinical trial (ClinicalTrials.gov: NCT05929599) at Vietnam National Children's Hospital to evaluate nasal-spraying Bacillus spore probiotics (LiveSpo Navax containing B. subtilis ANA4 and B. clausii ANA39 at ≥1 billion CFU/mL) in children aged 1-24 months with pneumonia due to RSV and bacterial co-infection. Participants were randomly assigned in a 1:1 ratio to receive standard care plus either LiveSpo Navax or physiological saline solution, using a simple sealed-number draw at enrollment. Primary outcomes were the median duration required to resolve common pneumonia symptoms, duration of oxygen therapy, and total treatment days. RESULTS: A total of 120 children are enrolled (60 per group). In the final analysis, 50 participants in the Control group and 51 in the Navax group are included. The trial is completed with no serious adverse events or treatment-related side effects in either group. Navax treatment shortens the duration of eight symptoms associated with RSV pneumonia by one day, oxygen therapy by two days, and overall treatment by one day. CONCLUSIONS: The nasal-spraying Bacillus spore approach presents a safe, effective, and fast treatment for young children with pneumonia due to RSV and bacterial co-infections, making it especially a promising strategy for resource-limited settings.