OM-85 in Paediatric Recurrent Respiratory Tract Infections With Wheezing Lower Respiratory Illness

Exclusion Criteria

• •Anatomic alterations of the respiratory tract.
• •Other chronic respiratory diseases (e.g., tuberculosis, cystic fibrosis).
• •Any autoimmune disease.
• •HIV infection or any type of congenital or iatrogenic immune deficiency (including IgA deficiency).
• •Known severe congenital heart disease.
• •Haematologic diseases.
• •Liver or kidney failure.
• •New-borns before 34 weeks of gestational age.
• •Malnutrition as per World Health Organization (WHO) definition.
• •Any known neoplasia or malignancy.
• •Treatment with the following medications:
• •1. Injection or oral administration of steroids within 4 weeks prior to study enrolment.
• •2. Previous and/or concomitant immunosuppressants, immunostimulants, or gamma globulins within 6 months prior to study enrolment.
• •Previous use within last 6 months of enrolment or ongoing use of bacterial lysates.
• •Any major surgery within the last 3 months prior to study enrolment.
• •Known allergy or previous intolerance to investigational medicinal products (IMP).
• •Any other clinical conditions, that in the opinion of the Investigator, would not allow safe completion of the clinical study.
• •Other household members have previously been randomised in this clinical study.
• •Subjects' families expected to relocate out of study area within 24 months of the initiation of the study.
• •Currently enrolled in or has completed any other investigational device or drug study or receiving other investigational agent(s) within \<30 days prior to screening.
• •Parents or legally acceptable representative (LAR) who do not have access to internet connection.
• •Wheezing documented to be caused by gastroesophageal reflux.