NCT05984004

Safety Evaluation of Intranasal Use of DSM 32444 Postbiotic in Humans

Completed NA Last updated 12 April 2024

What this trial tests

NA trial testing 0.9% NaCl isotonic saline solution in Rhino Sinusitis in 60 participants. Completed in 20 April 2023.

Timeline

26 September 2022

Primary endpoint
22 November 2022

20 April 2023

Quick facts

Lead sponsor	Huro Biotech Joint Stock Company
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	60
Start date	26 September 2022
Primary completion	22 November 2022
Estimated completion	20 April 2023
Sites	1 location across Vietnam

Drugs / interventions tested

• 0.9% NaCl isotonic saline solution — full drug profile →
• Bacillus subtilis DSM32444, inactivated

Conditions studied

• Rhino Sinusitis — all drugs for Rhino Sinusitis →

Sponsor

Huro Biotech Joint Stock Company — full company profile →

Who can join

18 and older, any sex, with Rhino Sinusitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. A Comprehensive Overview of Postbiotics with a Special Focus on Discovery Techniques and Clinical Applications.
   Kumar A, Green KM, Rawat M. · · 2024 · cited 34× · PMID 39335866 · DOI 10.3390/foods13182937
2. Intranasal administration of DSM 32444 <i>Bacillus subtilis</i> spores: safety and tolerability.
   Ho YT, Hynes D, Martina Y, Love B, et al · · 2024 · cited 2× · PMID 38963177 · DOI 10.1099/jmm.0.001845