Safety Evaluation of Intranasal Use of DSM 32444 Postbiotic in Humans

• Status: Completed
• Trial end date: 2023-04-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Huro Biotech Joint Stock Company
• Collaborator: Thai Binh University of Medicine and Pharmacy

Criteria

Inclusion Criteria:

• Healthy volunteers must be ≥18 years of age, at the time of signing the informed consent.

• Participants who are able to use an e-Diary or Paper Diary during the study to report their health status

• Participants capable of giving a signed informed consent form (ICF)

Exclusion Criteria:

• Planned travel outside of the study area during the study period.

• Use of any investigational drug within 30 days prior to Day screening. No investigational products are permitted for use during the conduct of this study

• A known history of alcohol or drug abuse within the last 2 years

• Existence of any medical condition, which in the opinion of the investigator, might significantly affect the subject's ability to complete this trial; or their safety in this trial