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A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety of Postbiotic Nasal Spray Using Killed Spores of Bacillus Subtilis DSM32444 in Healthy Volunteers
Sponsor study identifier
interventional
60
1 country
1
Study Start
September 26, 2022
Actual (reported)Primary Completion
November 22, 2022
Actual (reported)Study Completion
April 20, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 20, 2023
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 26, 2022
Actual (reported)November 22, 2022
Actual (reported)April 20, 2023
Actual (reported)July 31, 2023
Actual (reported)August 9, 2023
Actual (reported)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
Healthy volunteers in Control group receives a nasal spray containing 0.9% NaCl isotonic saline solution.
Healthy volunteers in SPEROVID group receives a nasal spray containing inactivated Bacillus subtilis DSM32444 (postbiotic)
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.
Thai Binh University of Medicine and Pharmacy
Thái Bình, Thai Binh, Vietnam
Baraniuk JN. Pathogenic mechanisms of idiopathic nonallergic rhinitis. World Allergy Organ J. 2009 Jun 15;2(6):106-14. doi: 10.1097/WOX.0b013e3181aadb16.
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.
Kien T NGUYEN, PhD
Thai Binh University of Medicine and Pharmacy
60 participants (actual enrollment reported by the registry).
First Submitted
July 31, 2023
First Posted
August 9, 2023
Study Start
September 26, 2022
Actual (reported)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
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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.
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.
Primary Completion
November 22, 2022
Actual (reported)Study Completion
April 20, 2023
Actual (reported)Last Updated
April 12, 2024
Record last verified: 2024-04
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