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

NACompletedINTERVENTIONAL
Enrollment

600

Participants

Timeline

Start Date

January 2, 2024

Primary Completion Date

May 15, 2024

Study Completion Date

October 23, 2024

Conditions
Respiratory DiseaseRespiratory 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.

Trial Locations (1)

10000

Son Tay Province, Hanoi, Hanoi

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Hanoi Medical University

OTHER

lead

Anabio R&D

INDUSTRY

NCT06148194 - Efficacy of Probiotics (LiveSpo Navax) in Preventing Respiratory Diseases in Children | Biotech Hunter | Biotech Hunter