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

• Status: Completed
• Trial end date: 2023-05-25
• 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. 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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Huro Biotech Joint Stock Company
• Collaborator: Vietstar Biomedical Research
• Treatments: Neomycin; Xylometazoline

Criteria

Inclusion Criteria:

• Confirmed rhinosinusitis patients (according to Vietnam's MOH guidelines for diagnosis of rhinosinusitis), ≥18 years of age, at the time of signing the informed consent.

• Must be in generally good health, except rhinosinusitis

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

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

Exclusion Criteria:

• Presence of any nasal mucosal erosion, nasal ulceration, or nasal septal perforation (Grade 1b - 4)

• Other nasal disease(s) likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa, clinically significant polyposis, or nasal structural abnormalities.

• Nasal surgery or sinus surgery within the previous year

• Chronic sinusitis - more than 3 episodes per year

• Asthma (with the exception of mild, intermittent asthma). Subjects with mild, intermittent asthma who only require short-acting inhaled bronchodilators (not more often than twice per week) and who do not have nocturnal awakening as a result of asthma are eligible for enrolment.

• 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.

• 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.