Safety and Efficacy of DSM 32444 Postbiotic in the Treatment of Acute Rhinosinusitis

NACompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

December 29, 2022

Primary Completion Date

April 27, 2023

Study Completion Date

May 25, 2023

Conditions
RhinosinusitisRhinitis
Interventions
DRUG

Neomycin/ Dexameythasone/Xylometazoline

The active-control in the phase II study was a commercial form of nasal spray containing Dexamethasone/Neomycin/Xylometazoline. This formulation is approved by Vietnam's Ministry of Health as a treatment regime for rhinosinusitis. Dexamethasone sodium phosphate is fluoromethyl prednisolone, a synthetic glucocorticoid. Dexamethasone has the main effects of glucocorticoids as anti-inflammatory, antiallergic and immunosuppressant. Neomycin sulfate is an antibiotic belonging to the group of aminoglycosides that have a bactericidal mechanism due to inhibition of bacterial protein biosynthesis. In this study, the nasal spray is used as an adjunct to Amoxicillin/Clavulanate standard treatment

COMBINATION_PRODUCT

Bacillus subtilis DSM32444

Postbiotic DSM32444 is manufactured by HURO BIOTECH Company as a drug-grade active pharmaceutical ingredient. The Class A medical device containing Postbiotic DSM32444 is called Sperovid, which is manufactured by Dong Duoc Viet under ISO 13485:2016 standards for medical device. Sperovid has registration number: 220000033/ PCBALA In this study, the nasal spray is used as an adjunct to Amoxicillin/Clavulanate standard treatmen.

Trial Locations (1)

Unknown

Thai Binh University of Medicine and Pharmacy, Thái Bình

Sponsors
All Listed Sponsors
collaborator

Vietstar Biomedical Research

INDUSTRY

lead

Huro Biotech Joint Stock Company

INDUSTRY

NCT05999955 - Safety and Efficacy of DSM 32444 Postbiotic in the Treatment of Acute Rhinosinusitis | Biotech Hunter | Biotech Hunter