Efficacy of Probiotics (LiveSpo Navax) in Preventing Respiratory Diseases in Children

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.

Conditions

• Respiratory Disease
• Respiratory Infections in Children

Interventions

DRUG

0.9% NaCl physiological saline

Nasal-spraying 0.9% NaCl physiological saline is prepared by extracting 5 mL from 0.9% NaCl intravenous infusion 500 mL PP bottle (B.Braun, Germany, product declaration No. Nasal-spraying 0.9% NaCl physiological saline is prepared by extracting 30 mL from 0.9% NaCl intravenous infusion 500 mL PP bottle (B.Braun, Germany, product declaration No. VD-32732-19), and then pouring it into the same opaque plastic spraying 30 mL-bottle that is used for probiotic 1 and 2.

COMBINATION_PRODUCT

Probiotic 1

In Vietnam, LiveSpo Navax is manufactured as a Class-A medical device (Product declaration: No. 210001337/PCBA-HN) in accordance with manufacturing standards approved by the Hanoi Health Department, Ministry of Health, Vietnam (Certificate No. YT117-19), and ISO 13485:2016. LiveSpo Navax product is prepared in the form of NaCl 0.9% plus B. subtilis and B. clausii at 1 billion CFU/mL x 30 mL.

COMBINATION_PRODUCT

Probiotic 2

In Vietnam, LiveSpo Navax Kid is manufactured as a Class-A medical device (Product declaration: No. 220002534/PCBA-HN) in accordance with manufacturing standards approved by the Hanoi Health Department, Ministry of Health, Vietnam (Certificate No. YT117-19), and ISO 13485:2016. LiveSpo Navax Kid is prepared in the form of NaCl 0.9% plus B. subtilis and B. clausii at 0.6 billion CFU/mL x 30 mL.

Sponsors & Collaborators

• Hanoi Medical University

  collaborator OTHER

• Anabio R&D

  lead INDUSTRY

Principal Investigators

• Thu TH Nguyen, Assoc. Prof. · Hanoi Medical University

• Anh TV Nguyen, Assoc. Prof. · Spobio Research Center, Anabio R&D

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

2 Years

Max Age

5 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-01-02

Primary Completion

2024-05-15

Completion

2024-10-23

Countries

• Vietnam

Study Locations