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Brief 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

Outcome Measures

Primary Outcomes (1)

Percentage of patients with free respiratory symptoms
Percentage (%) of RSV-infected patients with free respiratory symptoms including runny nose, chest depression, difficulty breathing, dry rales, and moist rales
Day 0 to day 6

Secondary Outcomes (7)

Patient's breath
Day 0 to day 6
Patient's pulse
Day 0 to day 6
Patient's temperature
Day 0 to day 6
Patient's pulse oxygen (SpO2)
Day 0 to day 6
RSV concentration
Day 0 and day 3
+2 more secondary outcomes

Study Arms (2)

Control

PLACEBO COMPARATOR

Control group receives the routine treatment and uses 0.9% NaCl physiological saline: Routine treatment is as follows: * Oral administrative drugs: antipyretic paracetamol (Efferegant®️); anti-inflammatory corticosteroid methylprednisolon; antibiotics e.g. ampicillin and sulbactam complex (Ama-power®️), tobramycin (Medphatobra®️), or cefotaxim (Goldcefo®️), based on the results of antibiotic susceptibility test. * Aerosol therapy: bronchodilator e.g. salbutamol (Ventolin ®️inhaler) or budesonide (Pulmicort ®️Respules).

Drug: 0.9% NaCl physiological saline

Navax

EXPERIMENTAL

Navax group receives the routine treatment and uses NaCl 0.9% plus B. subtilis and B. clausii at 5 billions CFU/5 mL (LiveSpo®️ Navax): Routine treatment is as follows: * Oral administrative drugs: antipyretic paracetamol (Efferegant®️); anti-inflammatory corticosteroid methylprednisolon; antibiotics e.g. ampicillin and sulbactam complex (Ama-power®️), tobramycin (Medphatobra®️), or cefotaxim (Goldcefo®️), based on the results of antibiotic susceptibility test. * Aerosol therapy: bronchodilator e.g. salbutamol (Ventolin ®️inhaler) or budesonide (Pulmicort ®️Respules).

Interventions

LiveSpo NavaxCombination product

In Vietnam, LiveSpo Navax is manufactured as a Class-A medical device product (Product declaration No.210001337/PCBA-HN) under manufacturing standards approved by Hanoi Health Department, Ministry of Health, Vietnam (Certificate No YT117-19) and ISO 13485:2016.

Also known as: Registration number: No.210001337/PCBA-HN

Navax

0.9% NaCl physiological salineDrug

Related Publications (34)

Lima SF, Teixeira AG, Higgins CH, Lima FS, Bicalho RC. The upper respiratory tract microbiome and its potential role in bovine respiratory disease and otitis media. Sci Rep. 2016 Jul 1;6:29050. doi: 10.1038/srep29050.

PMID: 27363739RESULT

Chotirmall SH, Gellatly SL, Budden KF, Mac Aogain M, Shukla SD, Wood DL, Hugenholtz P, Pethe K, Hansbro PM. Microbiomes in respiratory health and disease: An Asia-Pacific perspective. Respirology. 2017 Feb;22(2):240-250. doi: 10.1111/resp.12971.

PMID: 28102970RESULT

Study Design

Study Type

interventional

Phase

not applicable

Allocation

RANDOMIZED

Masking

TRIPLE

Who Masked

PARTICIPANT, CARE PROVIDER, INVESTIGATOR

Masking Details

LiveSpo Navax and placebo 0.9% NaCl physiological saline are indistinguishable regarding taste and smell. The color and turbidity of LiveSpo Navax suspension is unrecognizable to investigators except the PI and analyzer, nurses, patient's parents, and patients due to opaque plastic container.

Purpose

TREATMENT

Intervention Model

PARALLEL

Model Details: Blind, randomized, and controlled clinical trial

Sponsor Type

OTHER

Responsible Party

PRINCIPAL INVESTIGATOR

PI Title

Vice Director of International Center, Vietnam National Children's Hospital

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (2)

Control

Navax

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (34)

Related Links

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (2)

Control

Navax

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (34)

Related Links

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations