om-85 in paediatric recurrent respiratory tract infections with wheezing lower respiratory illness

Conditions: Respiratory Tract Infections; Wheezing Lower Respiratory Illness

Summary: this study will assess the efficacy and safety of om-85 compared to placebo in reducing the number of respiratory tract infections (rtis) in children aged between 6 months and 5 years.

this is a phase 4, randomised, double-blind, placebo-controlled study to assess the efficacy and safety of short- and long-term treatment with om-85. the study will consist of screening (up to 20 days before randomisation), treatment period of 12 months, and an observational period of 6 months. the subjects will be randomised in a ratio of 1:1:1 ratio to receive either om-85 for 12 consecutive months (bv-12 arm), or om-85 for 3 consecutive months followed by matching placebo for 9 consecutive months (bv-3 arm), or placebo for 12 consecutive months (placebo arm). the expected duration of subject participation is 18 months (+20 days)

Eligibility criteria:
inclusion criteria: * children of either gender aged between 6 months and 5 years, at baseline/randomisation (visit 2) inclusive. * for children ≥1 year of age, ≥4 rtis (as reported by parents or lar of subject), including ≥2 episodes of wlris (including ≥1 triggering hospitalisation or medical visit) within 12 months prior to enrolment. or * for children \<1 year of age, ≥2 rtis (as reported by parents or lar of subject), including ≥1 episode of wlris (including ≥1 triggering hospitalisation or medical visit) within 6 months prior to enrolment. * parents or lar of subject have provided the appropriate written informed consent. written informed consent must be provided before any study-specific procedures are performed including screening procedures. 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.