Safety Evaluation of Intranasal Use of DSM 32444 Postbiotic in Humans
Status:
Completed
Trial end date:
2023-04-20
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. 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. A common treatment regime
for patients with rhinosinusitis in Vietnam includes a combination of steroids and
antibiotics (Neomycin/Dexamethasone/ Xylometazoline) administered as a nasal spray, in
adjunct with Amoxicillin/clavulanate 875/125 mg taken orally every 12- hours. The duration of
treatment for patients is about 10 days depending on the severity of the disease. During the
treatment period, a change in the systemic antibiotic regimen is necessary if the
observations after 3 to 5 days of treatment do not show signs of a satisfactory response.
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.
There have been multiple research studies supporting the efficacy of bacterialbased
approaches in the prevention of viral respiratory infections, and that have potential for
treatment. For use in the respiratory tract, it is necessary to have a completely sterile
product to ensure safety in the long-term and there is a need for safety assessment of
products both in animal models and human studies.
This phase of the study aims to evaluate the safety in humans of a nasal spray using a
postbiotic preparation of Bacillus subtilis DSM32444 and that is a sterile inert bioparticle.