Safety Evaluation of Intranasal Use of DSM 32444 Postbiotic in Humans

NCT05984004 | Completed

• 1 other identifier: HSP32444.01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rhino Sinusitis

Keywords

Acute Rhinosinusitis; Chronic Rhinosinusitis; Allergic Rhinosinusitis

Outcome Measures

Primary Outcomes (1)

• To compare the safety and tolerability following multiple doses of postbiotic DSM32444 nasal spray for 7 days with Placebo in Heathy Volunteers

  * Incidence of Adverse Events (Nasal Congestion, Itchy Nose, Allergic Reaction/Rash, Sneezing, Nasal Discharge, Weeping, Itchy eyes, Itchy ears, Sore throat, Nausea/Vomiting) * Incidence of Serious Adverse Events (Adverse events leading to discontinuation of study products, Adverse events leading to withdrawal of subjects from the study, Deaths up to the time of study data cut off) * Incidence of Related Adverse Events * Incidence of Related Serious Adverse Events

  Day 1 to Day 7

Study Arms (2)

Control

PLACEBO COMPARATOR

Healthy volunteers in Control group receives a nasal spray containing 0.9% NaCl isotonic saline solution.

Drug: 0.9% NaCl isotonic saline solution

SPEROVID

EXPERIMENTAL

Healthy volunteers in SPEROVID group receives a nasal spray containing inactivated Bacillus subtilis DSM32444 (postbiotic)

Combination Product: Bacillus subtilis DSM32444, inactivated

Interventions

0.9% NaCl isotonic saline solution DRUG

The placebo-control in the phase I study was a 0.9% NaCl isotonic saline solution. This nasal spray solution has no pharmacological effect, but is considered to have a cleansing effect on the nose, supporting the treatment of nasal symptoms in nasal pathology. The solution is prepared by extracting 5 mL from 0.9% NaCl intravenous infusion 500 mL PP bottle (B.Braun, Germany, product declaration No. VD-32732-19). The solution is bottled in the same fully-sealed nasal spray device containing Bacillus subtilis DSM 32444 postbiotic, used for Sperovid.

Also known as: 0.9% NaCl

Control

Bacillus subtilis DSM32444, inactivated COMBINATION_PRODUCT

Postbiotic DSM32444 is manufactured by HURO BIOTECH Company as a drug-grade active pharmaceutical ingredient. The Class A medical device containing Postbiotic DSM32444 is called Sperovid, which is manufactured by Dong Duoc Viet under ISO 13485:2016 standards for medical device. Sperovid has registration number: 220000033/PCBA-LA

Also known as: Sperovid, Speromed, Sperokid, SPOR-COV

SPEROVID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Huro Biotech Joint Stock Company: lead
• Thai Binh University of Medicine and Pharmacy: collaborator

Study Sites (1)

Thai Binh University of Medicine and Pharmacy

Thái Bình, Thai Binh, Vietnam

Location

Related Publications (4)

• Baraniuk JN. Pathogenic mechanisms of idiopathic nonallergic rhinitis. World Allergy Organ J. 2009 Jun 15;2(6):106-14. doi: 10.1097/WOX.0b013e3181aadb16.

  PMID: 24229057 BACKGROUND

• James J, Meyer SM, Hong HA, Dang C, Linh HTY, Ferreira W, Katsande PM, Vo L, Hynes D, Love W, Banyard AC, Cutting SM. Intranasal Treatment of Ferrets with Inert Bacterial Spores Reduces Disease Caused by a Challenging H7N9 Avian Influenza Virus. Vaccines (Basel). 2022 Sep 19;10(9):1559. doi: 10.3390/vaccines10091559.

  PMID: 36146637 BACKGROUND

• Wallace DV, Dykewicz MS, Bernstein DI, Blessing-Moore J, Cox L, Khan DA, Lang DM, Nicklas RA, Oppenheimer J, Portnoy JM, Randolph CC, Schuller D, Spector SL, Tilles SA; Joint Task Force on Practice; American Academy of Allergy; Asthma & Immunology; American College of Allergy; Asthma and Immunology; Joint Council of Allergy, Asthma and Immunology. The diagnosis and management of rhinitis: an updated practice parameter. J Allergy Clin Immunol. 2008 Aug;122(2 Suppl):S1-84. doi: 10.1016/j.jaci.2008.06.003. No abstract available.

  PMID: 18662584 BACKGROUND

• Huang JM, La Ragione RM, Nunez A, Cutting SM. Immunostimulatory activity of Bacillus spores. FEMS Immunol Med Microbiol. 2008 Jul;53(2):195-203. doi: 10.1111/j.1574-695X.2008.00415.x. Epub 2008 Apr 21.

  PMID: 18430003 BACKGROUND

MeSH Terms

Conditions

Rhinosinusitis; Rhinitis, Allergic, Perennial

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Rhinitis; Respiratory Tract Infections; Infections; Sinusitis; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Rhinitis, Allergic; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Kien T NGUYEN, PhD

  Thai Binh University of Medicine and Pharmacy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 9, 2023
• Study Start: September 26, 2022
• Primary Completion: November 22, 2022
• Study Completion: April 20, 2023
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)