600
Participants
Start Date
January 2, 2024
Primary Completion Date
May 15, 2024
Study Completion Date
October 23, 2024
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.
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.
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.
Son Tay Province, Hanoi, Hanoi
Lead Sponsor
Hanoi Medical University
OTHER
Anabio R&D
INDUSTRY