LiveSpo Navax® Supports the Treatment of Acute Rhinosinusitis and Otitis Media

Summary

Acute respiratory tract infections (ARTIs), such as acute rhinosinusitis (ARS) and acute otitis media (AOM), are common worldwide and caused by viruses or bacteria entering the body through the mouth and nose. AOM frequently occurs in young children and is caused by bacterial reflux into the middle ear. ARS is a relatively common ARTIs and can occur at many ages. To accurately diagnose disease, careful clinical examination and accurate clinical judgment are required, as making a reasonable treatment regimen with the decision to use antibiotics. Probiotics have long been known to have beneficial effects on the digestive system. Not only limited to the gastrointestinal tract but probiotics are also known for their role in reducing infections in the respiratory system. Recently, the investigators have successfully conducted a clinical trial of nasal-spray Bacillus spore probiotics in children infected with respiratory syncytial virus (RSV), and the data show that the probiotics can rapidly and effectively relieve symptoms of RSV-induced ARTIs while exhibiting strong impacts in reducing viral load and inflammation. Here, the investigators conducted a study that directly spraying probiotics into the nose can effectively support to treatment of both ARS and AOM.

The aim of the study about to evaluate the safety and effectiveness of nasal-spraying probiotics containing spores of Bacillus subtilis and Bacillus clausii in the supportive treatment of patients with ARS and AOM.

Study Population: sample size is 120. Description of Sites: the study is carried out at Thai Binh Medical University Hospital and Thai Binh Children's Hospital.

Description of Study Intervention: 120 eligible patients are divided into 2 groups (n=60/group) including the ARS group and the ARS accompanied by the AOM (ARS \& AOM) group. 60 patients in each of the above groups were randomly assigned to two subgroups (n=30/subgroup): Patients in the Control-ARS and Control-ARS \& AOM subgroups received the routine treatment and three times per day nasal-spraying 0.9% NaCl physiological saline. In contrast, the patients in the Navax-ARS and Navax-ARS \& AOM subgroups received three times per day nasal-spraying LiveSpo Navax® in addition to the same standard of care treatment. The standard treatment regimen is 3-7 days, depending on the severity of the disease when the patient arrives for the exam and the progression of the disease during the treatment period.

Study duration: 18 months

Conditions

• Upper Respiratory Tract Infections

Interventions

DRUG

0.9% NaCl physiological saline Nasal-spraying

0.9% NaCl physiological saline 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), and then pouring it into the same opaque plastic spraying 10 mL-bottle that is used for LiveSpo Navax.

COMBINATION_PRODUCT

LiveSpo Navax®

In Vietnam, LiveSpo Navax® is manufactured as a Class-A medical device product (Product declaration No.210001337/PCBA-HN) under manufacturing standards approved by Hanoi Health Department, Ministry of Health, Vietnam (Certificate No YT117-19) and ISO 13485:2016

DRUG

Augmentin 500Mg Tablet

Augmentin (GlaxoSmithKline Pte, product declaration No. VN-20169-16) is an oral antibiotic available in the form of 625 mg tablets, which are prescribed as routine treatment for children and adults, respectively.

DRUG

Acetylcysteine

Acetylcysteine 200 mg (STADA Vietnam, product declaration No. VD-22667-15) is an oral expectorant, which is prescribed as routine treatment for children and adults, respectively.

DRUG

Xylometazoline Nasal

Otrivin (Xylometazoline 0.05%) (Novartis VietNam, product declaration No. VN-15558-12) is a nasal-spraying decongestant, which is prescribed as routine treatment for children and adults, respectively.

DRUG

Cefotaxime

Imetoxim 1g (Cefotaxime 1g) (Imexpharm Pharmaceutical, product declaration No. VD-26846-17) is an injection or infusion-administrative antibiotic, which is prescribed as routine treatment for children.

DRUG

Ciprofloxacin

Ciprofloxacin 0.3% (Vidipha Central Pharmaceutical, product declaration No. VD-15205-11) is an antibiotic ear drop, which is prescribed as routine treatment for children.

Sponsors & Collaborators

• Thai Binh University of Medicine and Pharmacy

  collaborator OTHER

• Anabio R&D

  lead INDUSTRY

Principal Investigators

• Thanh Khieu Huu, MD.,PhD · Thai Binh University of Medicine and Pharmacy

• Binh Nguyen Thanh, Assoc. Prof. · Thai Binh University of Medicine and Pharmacy

• Anh Nguyen Thị Vân, Assoc. Prof. · Anabio R&D Ltd

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

6 Months

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-10-28

Primary Completion

2024-04-05

Completion

2024-08-01

Countries

• Vietnam

Study Locations