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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05804123
Other study ID # TNLS.2021.03
Secondary ID 872/HÐÐÐ
Status Recruiting
Phase N/A
First received
Last updated
Start date October 28, 2021
Est. completion date June 1, 2024

Study information

Verified date March 2024
Source Anabio R&D
Contact Thanh Khieu Huu, MD.,PhD
Phone (+84) 983.036.056
Email Khieuthanh@tbump.edu.vn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Description:

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Study Design


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Intervention

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Locations

Country Name City State
Vietnam Thai Binh University of Medicine and Pharmacy, Thai Binh Medical University Hospital and Thai Binh Children's Hospital Thai Binh

Sponsors (2)

Lead Sponsor Collaborator
Anabio R&D Thai Binh University of Medicine and Pharmacy

Country where clinical trial is conducted

Vietnam, 

References & Publications (10)

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Outcome

Type Measure Description Time frame Safety issue
Primary Changes in percentages of patients with free acute rhinosinusitis symptoms Changes in percentage (%) of acute rhinosinusitis patients with free acute rhinosinusitis symptoms include nasal blockage/obstruction/congestion or runny nose, sneezing, headache, sinus pain (facial pain), loss of smell Day 3 compared to Day 0; Day 7 compared to Day 0
Primary Changes in percentages of patients with free acute otitis media symptoms Changes in percentages (%) of acute otitis media patients with free acute otitis media symptoms include fever, purulent discharge from the ear canal (ear discharge or otorrhea), earache (rubbing or pulling on the earlobe, tossing or turning, difficulty sleeping or crying), headache, and hearing loss temporary (poor response to sound), vomiting or diarrhea. Day 3 compared to Day 0
Secondary Changes in infection bacterial concentrations can cause acute rhinosinusitis (ARS) and acute otitis media (AOM) Changes in infection bacterial (S. pneumoniae, H. influenzae, M. catarrhalis) concentrations in nasopharyngeal samples on both ARS and ARS accompanied by AOM groups and ear samples in the ARS accompanied by AOM group, as indicated by real-time PCR threshold cycle (Ct) values Day 3 compared to Day 0 and/or Day 7 compared to Day 0
Secondary Changes in cytokines level Changes in levels of tumor necrosis factor-a (TNF-a) (pg/mL), interleukin-6 (IL-6) (pg/mL), and interleukin-8 (IL-8) (pg/mL)... in nasopharyngeal samples on both ARS and ARS accompanied by AOM groups and ear samples in the ARS accompanied by AOM group Day 3 compared to Day 0 and/or Day 7 compared to Day 0
Secondary Changes in immunoglobulin A level Changes in level of immunoglobulin A (IgA) (ng/mL) in nasopharyngeal samples on both ARS and ARS accompanied by AOM groups and ear samples in the ARS accompanied by AOM group Day 3 compared to Day 0 and/or Day 7 compared to Day 0
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