Efficacy of Probiotics (LiveSpo Navax) in Preventing Respiratory Diseases in Children
Status:
Recruiting
Trial end date:
2024-12-01
Target enrollment:
Participant gender:
Summary
Acute respiratory infections are common diseases worldwide with the highest incidence and
mortality rates, especially among children. Currently, the prevention of acute respiratory
infections in children still faces certain limitations. Although there is a vaccine available
for influenza, there are no vaccines yet for RSV and adenovirus in children, and influenza
vaccination needs to be repeated annually to achieve optimal effectiveness. Therefore,
maintaining respiratory and throat hygiene is essential for both treatment and prevention,
ensuring respiratory health for children and reducing the risk of bacterial co-infections. In
recent years, preventive strategies for respiratory inflammation have garnered increasing
attention, with probiotics being shown to have the potential to support treatment and
prevention & reduce the risk of recurrent respiratory infections, thus decreasing reliance on
antibiotics. Here, the investigators propose that direct nasal spraying of probiotics may be
safe and effective in preventing respiratory diseases.
The aim of the study is to evaluate the effectiveness of two types of nasal- praying Bacillus
probiotics including LiveSpo Navax (1 billion/mL x 30 mL B. subtilis and B. clausii) and
LiveSpo Navax Kid (0.6 billion/mL x 30 mL B. subtilis and B. clausii) in preventing
respiratory diseases. Study Population: The sample size is 600. Description of Sites: The
study is conducted at preschools in Son Tay Province, Hanoi, Vietnam.
Description of Study Intervention: A total of 600 eligible children are randomly divided into
three groups (n = 200/group each). Children in the Control group received 0.9% NaCl
physiological saline twice daily (morning and afternoon), with 2 sprays in each nostril and 2
sprays in the throat each time (totally 6 sprays each time), continuously for four weeks.
Children in the Probiotic 1 group receive LiveSpo Navax product, and children in the
Probiotic 2 group receive LiveSpo Navax Kid, with the same dosage and frequency as the
Control group.
Study Duration: 12 months.