Safety and Efficacy of DSM 32444 Postbiotic in the Treatment of Acute Rhinosinusitis
Status:
Completed
Trial end date:
2023-05-25
Target enrollment:
Participant gender:
Summary
Rhinitis is a type of upper respiratory infection with a common nasal pathology especially in
Southeast Asia, which is characterized by the presence of one or more of the following
symptoms: itchy nose, sneezing, runny nose, and nasal congestion. Other symptoms occasionally
experienced include headache, excessive pain reaction, cough, fever. Rhinitis can be
idiopathic or due to a variety of causes, including allergens, medications,
endocrine/metabolic, infectious, inflammatory, and abnormal nasal structures. The treatment
of acute rhinosinusitis and allergic rhinitis in hospitals is currently carried out according
to the general professional guidance of the Vietnam Ministry of Health. Most patients are
prescribed corticosteroids, antihistamines, and antibiotics for immediate decongestion and
anti-inflammatory effects. Current concerns about antimicrobial resistance (AMR) as well as
side effects of corticosteroids and antihistamines have led to an urgent need for a
naturebased next generation therapeutic approach that is safe, effective and helps in
addressing the issues of AMR. The goal of this interventional study is to evaluate the safety
and efficacy of postbiotic nasal spray using inert bioparticles of Bacillus subtilis DSM32444
in treatment of acute rhinosinusitis; and to compare the efficacy against
Neomycin/Dexamethasone//Xylometazoline administered as a nasal spray as an adjunct to
Amoxicillin/Clavulanate standard treatment in patients with acute rhinosinusitis.
Patients with acute rhinosinusitis who give consent to participate in the study will be
randomly assigned in a 1:1 ratio to one of two groups using postbiotic of Bacillus subtilis
DSM32444 nasal spray ("Sperovid") or Neomycin/ Dexamethasone nasal spray for a period of 10
days. Investigators will compare whether the nasal spray using postbiotic Bacillus subtilis
DSM32444 has similar efficacy as compared to Neomycin/Dexamethasone/Xylometazoline nasal
spray as an adjuvant therapy along with the standard Amoxicillin/Clavulanate regimen in
patients with acute rhinosinusitis based on time to improvement of rhinosinusitis symptoms.