Application of LiveSpo Navax® in the Treatment Support of Acute Rhinosinusitis and Acute Otitis Media

TNLS.2021.03

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

2021-10-28

2024-06-01

2024-06-01

Recruiting

120

Inclusion Criteria: * Patients diagnosed with acute rhinosinusitis: sudden onset of two or more symptoms, one of which should be either nasal blockage/obstruction/congestion or nasal discharge (anterior/posterior nasal drip); and/or facial pain/pressure; and/or reduction or loss of smell for \<12 weeks. In children: sudden onset of two or more of the symptoms: nasal blockage/obstruction/congestion or discolored nasal discharge, or cough (daytime and night-time) for \< 12 weeks * Patients diagnosed with acute rhinosinusitis accompanied by acute otitis media: patients from 6 months to 7 years old, suffer from onset ear discharge not caused by otitis external, the tympanic membrane was ruptured with purulent. * Patients are hospitalized or treated as outpatients but need periodic re-examination * Have a complete medical record or medical examination book * For patients under 18 years old, the patient's parents agreed to participate in the study that was explained and signed the study consent form. * Patients \>18 years old: patients agreed to participate in the study, explained, and signed the study consent form. Exclusion Criteria: * The patient did not agree to participate in the study. * There are not enough medical records or medical examination books. * The patient moves out of the treatment unit (not for professional reasons). * The outpatients but no periodic re-examination. * Patients with congenital deafness, or deafness due to neurological causes: meningitis, obstetric complications, ear poisoning... * Patients with congenital disease-causing disorders of maxillofacial development and mental and physical retardation.

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Blind randomized controlled trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': "LiveSpo Navax® and placebo 0.9% NaCl physiological saline are indistinguishable regarding taste and smell. The color and turbidity of LiveSpo Navax® suspension is unrecognizable to investigators except the PI and analyzer, nurses, patient's parents, and patients due to opaque plastic container.", 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}

2024-03-15