LiveSpo Navax® Supports the Treatment of Acute Rhinosinusitis and Otitis Media
Status:
Recruiting
Trial end date:
2023-09-01
Target enrollment:
Participant gender:
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