Effects of Nasal-spraying LiveSpo Navax in Treatment of Acute Respiratory Infections in Children

• Status: Completed
• Trial end date: 2021-08-29
• Target enrollment: 0
• Participant gender: All

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Children's Hospital, Vietnam

Criteria

Inclusion Criteria:

• Children (male/female) aged from 4 to 60 months.

• Admitted hospital due to lower respiratory infection.

• RSV is positive by rapid test.

• Parents of the pediatric patient agree to participate in the study, explain and sign the research consent form.

Exclusion Criteria:

• Newborn babies.

• Have a history of drug allergy.

• Need oxygen therapy.

• Discharged before day 3.

• Lost to follow-up.

• Withdrawn from the trial.

• Continuing in the trial but missing data.

• Meeting the criteria for psychiatric disorders other than depression and/or anxiety.