Efficient symptomatic treatment and viral load reduction for children with influenza virus infection by nasal-spraying Bacillus spore probiotics.

2023-09-08
Scientific reports 13(1)
- Tu Thanh Tran
- Thuy Thi Bich Phung
- Dien Minh Tran
- Huyen Thi Bui
- Phuc Thanh Thi Nguyen
- Tam Thi Vu
- Nga Thi Phuong Ngo
- Mai Thi Nguyen
- Anh Hoa Nguyen
- Anh Thi Van Nguyen

PubMed: 37684332
DOI: 10.1038/s41598-023-41763-5

Study Design

Type: Randomized Controlled Trial (RCT)
Population: pediatric patients
Methods: double-blind, randomized, and controlled clinical trial examining the efficacy of nasal-spraying probiotic LiveSpo Navax, which contains 5 billion of Bacillus subtilis and B. clausii spores in 5 mL, in supporting treatment of influenza viral infection
Blinding: Double-blind
Funding: Unclear

Rigorous Journal

Influenza virus is a main cause of acute respiratory tract infections (ARTIs) in children. This is the first double-blind, randomized, and controlled clinical trial examining the efficacy of nasal-spraying probiotic LiveSpo Navax, which contains 5 billion of Bacillus subtilis and B. clausii spores in 5 mL, in supporting treatment of influenza viral infection in pediatric patients. We found that the nasal-spraying Bacillus spores significantly shortened the recovery period and overall treatment by 2 days and increased treatment effectiveness by 58% in resolving all ARTIs' symptoms. At day 2, the concentrations of influenza virus and co-infected bacteria were reduced by 417 and 1152 folds. Additionally, the levels of pro-inflammatory cytokines IL-8, TNF-α, and IL-6 in nasopharyngeal samples were reduced by 1.1, 3.7, and 53.9 folds, respectively. Compared to the standard control group, treatment regimen with LiveSpo Navax demonstrated significantly greater effectiveness, resulting in 26-fold reduction in viral load, 65-fold reduction in bacterial concentration, and 1.1-9.5-fold decrease in cytokine levels. Overall, nasal-spraying Bacillus spores can support the symptomatic treatment of influenza virus-induced ARTIs quickly, efficiently and could be used as a cost-effective supportive treatment for respiratory viral infection in general.Clinical trial registration no: NCT05378022 on 17/05/2022.

Research Insights

Bacillus clausii→Improved Symptom Resolution
increased treatment effectiveness by 58% in resolving all ARTIs' symptoms
Effect
Beneficial
Effect size
Large
Dose
5 billion spores in 5 mL (nasal spray)
Bacillus clausii→Increased Interleukin 8 Levels
levels of pro-inflammatory cytokines IL-8, TNF-α, and IL-6 in nasopharyngeal samples were reduced by 1.1, 3.7, and 53.9 folds
Effect
Beneficial
Effect size
Small
Dose
5 billion spores in 5 mL (nasal spray)
Bacillus clausii→Reduced Bacterial Load
concentrations of influenza virus and co-infected bacteria were reduced by 417 and 1152 folds
Effect
Beneficial
Effect size
Large
Dose
5 billion spores in 5 mL (nasal spray)
Bacillus clausii→Reduced Interleukin-6 Levels
levels of pro-inflammatory cytokines IL-8, TNF-α, and IL-6 in nasopharyngeal samples were reduced by 1.1, 3.7, and 53.9 folds
Effect
Beneficial
Effect size
Large
Dose
5 billion spores in 5 mL (nasal spray)
Bacillus clausii→Reduced Recovery Period
nasal-spraying Bacillus spores significantly shortened the recovery period and overall treatment by 2 days
Effect
Beneficial
Effect size
Moderate
Dose
5 billion spores in 5 mL (nasal spray)
Bacillus clausii→Reduced Tumor Necrosis Factor Alpha
levels of pro-inflammatory cytokines IL-8, TNF-α, and IL-6 in nasopharyngeal samples were reduced by 1.1, 3.7, and 53.9 folds
Effect
Beneficial
Effect size
Large
Dose
5 billion spores in 5 mL (nasal spray)
Bacillus clausii→Reduced Viral Load
concentrations of influenza virus and co-infected bacteria were reduced by 417 and 1152 folds
Effect
Beneficial
Effect size
Large
Dose
5 billion spores in 5 mL (nasal spray)
Bacillus subtilis→Improved Symptom Resolution
increased treatment effectiveness by 58% in resolving all ARTIs' symptoms
Effect
Beneficial
Effect size
Large
Dose
5 billion spores in 5 mL (nasal spray)
Bacillus subtilis→Increased Interleukin 8 Levels
levels of pro-inflammatory cytokines IL-8, TNF-α, and IL-6 in nasopharyngeal samples were reduced by 1.1, 3.7, and 53.9 folds
Effect
Beneficial
Effect size
Small
Dose
5 billion spores in 5 mL (nasal spray)
Bacillus subtilis→Reduced Bacterial Load
concentrations of influenza virus and co-infected bacteria were reduced by 417 and 1152 folds
Effect
Beneficial
Effect size
Large
Dose
5 billion spores in 5 mL (nasal spray)
Bacillus subtilis→Reduced Interleukin-6 Levels
levels of pro-inflammatory cytokines IL-8, TNF-α, and IL-6 in nasopharyngeal samples were reduced by 1.1, 3.7, and 53.9 folds
Effect
Beneficial
Effect size
Large
Dose
5 billion spores in 5 mL (nasal spray)
Bacillus subtilis→Reduced Recovery Period
nasal-spraying Bacillus spores significantly shortened the recovery period and overall treatment by 2 days
Effect
Beneficial
Effect size
Moderate
Dose
5 billion spores in 5 mL (nasal spray)
Bacillus subtilis→Reduced Tumor Necrosis Factor Alpha
levels of pro-inflammatory cytokines IL-8, TNF-α, and IL-6 in nasopharyngeal samples were reduced by 1.1, 3.7, and 53.9 folds
Effect
Beneficial
Effect size
Large
Dose
5 billion spores in 5 mL (nasal spray)
Bacillus subtilis→Reduced Viral Load
concentrations of influenza virus and co-infected bacteria were reduced by 417 and 1152 folds
Effect
Beneficial
Effect size
Large
Dose
5 billion spores in 5 mL (nasal spray)