Effects of Nasal-spraying LiveSpo Navax in Treatment of Acute Respiratory Infections in Children
Status:
Completed
Trial end date:
2021-08-29
Target enrollment:
Participant gender:
Summary
Rationals: Infection with the Respiratory Syncytial Virus (RSV) is one of the most common
causes of respiratory tract diseases. However, treatment for pediatric RSV infection remains
supportive to prevent co-infection bacteria and respiratory failure. In recent years,
preventive and supportive probiotic therapies for respiratory tract infections (RTIs) have
been increasingly strengthened, however, the use of oral administrative probiotics as
functional foods is effective only for mild symptoms and not applicable for Acute RTIs
(ARTIs). Here, we propose that direct spraying of probiotics into the nose can be a fast and
effective symptomatic treatment for ARTIs.
Objectives: Investigate symptomatic treatment effects of probiotic product LiveSpo Navax, as
liquid-suspension form containing Bacillus spores of safe B. subtilis ANA4 and B. clausii
ANA39 strains, in children having acute respiratory diseases caused by RSV:
- Primary Objective: Evaluation of improved efficacy and reduced treatment time of LiveSpo
Navax in children infected with RSV.
- Secondary Objectives: Measurement of changes in RSV viral load, co-infectious bacterial
concentrations, and major cytokine indicators in the nasopharyngeal mucosa before and
after 3 days using LiveSpo Navax.
Endpoints:
Primary endpoint: LiveSpo Navax alleviates RSV-infection symptoms about 25% more effectively,
as indicated by 90% of patients using LiveSpo Navax (Navax group) are symptom-free at day 3-6
of intervention depending on symptoms, compared to 65% of patients in Control group.
Secondary endpoint: Patients in Navax group had more significant reductions in RSV load (>10
fold) than patients in Control group at day 3 of intervention.
Study Population: Sample size is 100. Description of Sites: The study is carried out at
Vietnam National Children's Hospital.
Description of Study Intervention: Totally 100 eligible patients are divided randomly into 2
groups (n = 50/group each): Patients in Control group received the routine treatment and
three times per day 0.9% NaCl physiological saline while the and patients in Navax group
received three times per day LiveSpo Navax in addition to the same standard of care
treatment. The standard treatment regimen is 3-6 days but can be extended further depending
on the severity of the patients' respiratory failure.
Study Duration: 12 months