Alleviating symptoms of paediatric acute rhinosinusitis and acute otitis media with otorrhea using nasal-spraying Bacillus probiotics: a randomized controlled trial

Acute rhinosinusitis (ARS) in children may be accompanied by acute otitis media (AOM) which is often associated with bacterial co-infections. These conditions are among the primary reasons that children visit hospitals and require antibiotic treatment. This study evaluated the efficacy of the nasal-...

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Bibliographic Details
Published in:Scientific reports 2025-01, Vol.15 (1), p.3410, Article 3410
Main Authors: Khieu, Thanh Huu, Le, Dung Phuong, Nguyen, Binh Thanh, Ngo, Binh Thanh, Chu, Hong Thi, Truong, Duc Minh, Nguyen, Hung Minh, Nguyen, Anh Hoa, Pham, Tung Dinh, Van Nguyen, Anh Thi
Format: Article
Language:English
Subjects:
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692/308/2779/777
692/308/3187
Acute Disease
Bacillus
Child
Child, Preschool
Children
Ear diseases
Female
Humanities and Social Sciences
Humans
Hyperemia
Immune response
Infant
Male
Middle ear
multidisciplinary
Nasal Sprays
Otitis media
Otitis Media - drug therapy
Otitis Media - microbiology
Otitis Media - therapy
Patients
Pediatrics
Probiotics
Probiotics - administration & dosage
Probiotics - therapeutic use
Rhinitis - microbiology
Rhinitis - therapy
Rhinosinusitis
Science
Science (multidisciplinary)
Single-Blind Method
Sinusitis - microbiology
Sinusitis - therapy
Spraying
Streptococcus infections
Treatment Outcome
Tumor necrosis factor-α
Tympanic membrane
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Summary:Acute rhinosinusitis (ARS) in children may be accompanied by acute otitis media (AOM) which is often associated with bacterial co-infections. These conditions are among the primary reasons that children visit hospitals and require antibiotic treatment. This study evaluated the efficacy of the nasal-spraying probiotics (LiveSpo Navax containing 5 billion Bacillus subtilis and B. clausii spores/5 mL) as a supportive treatment for dual ARS and AOM with otorrhea in a randomized, single-blind, controlled clinical trial. Eighty-two patients (41 per group), aged 1 month to 12 years, received standard care along with nasal spraying of either physiological saline (Control group) or LiveSpo Navax (Navax group), administered three times daily over a 7-day follow-up period. A total of sixty-one patients (30–31 per group) completed the trial. The Navax group experienced 68.00% and 96.77% reductions in nasal congestion (by day 3) and rhinorrhea (by day 7), respectively, which were 2.04 and 1.94-fold higher than the Control group, with odds ratios (OR) of 4.31 and 30.00 ( p   1200-fold reduction in Streptococcus pneumoniae and ≥ 4-fold reduction in Haemophilus influenzae concentrations ( p  
ISSN:2045-2322
2045-2322
DOI:10.1038/s41598-025-87372-2