Effects of Nasal-spraying LiveSpo Navax in Treatment of Influenza Virus in Children

• Status: Completed
• Trial end date: 2022-04-22
• Target enrollment: 0
• Participant gender: All

Summary

Acute Respiratory Tract Infections (ARTIs) in children are common diseases, with influenza virus types A and B is one of the main causes of serious symptoms in young children. Although an influenza vaccine is available, influenza vaccination requires annual injections, which made it difficult for young children to get effectively immunized. Moreover, antiviral nucleotide drugs including Tamiflu (oseltamivir) are unsafe for young children and are recommended only for high-risk patients. Probiotics have emerged as promising safe candidates for supportive treatment of ARTIs and reduction of antibiotic dependence in recent years. Here, we propose that direct spraying of probiotics into the nose can be a fast and effective symptomatic treatment for ARTIs due to influenza virus.

The aim of the study about to evaluate the effectiveness of nasal-spraying probiotics containing spores of two bacterial strains, Bacillus subtilis and Bacillus clausii in preventing and supporting the treatment of children having acute respiratory symptoms due to influenza infection.

Study Population: sample size is 70. Description of Sites: the study is carried out at Vietnam National Children's Hospital.

Description of Study Intervention: totally 70 eligible patients are divided randomly into 2 groups (n = 35/group each): Patients in Control group received the routine treatment and three times per day 0.9% NaCl physiological saline while the patients in the Navax group received three times per day LiveSpo Navax in addition to the same standard of care treatment. The standard treatment regimen is 2-5 days but can be extended further depending on the severity of the patient's respiratory failure.

Study duration: 15 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 months to 7 years

• Admitted to hospital due to upper respiratory infection

• Influenza A and B 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

• Having a history of drug allergies

• Need oxygen therapy

• Discharged before day 2

• 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• Withdrawn from the trial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.