University of Pisa | Department of Dermatology
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About
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.
Full description
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)
Enrollment
Sex
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Volunteers
Inclusion criteria
OR
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:
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.
Primary purpose
Allocation
Interventional model
Masking
525 participants in 3 patient groups, including a placebo group
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Central trial contact
Lorenz Lehr
Data sourced from clinicaltrials.gov
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