Immunomodulatory Effect of Pleuran in Children With Recurrent Respiratory Tract Infections

Study population:

Children aged 3-18 years with a history of RRTIs:

• Age 3 to 5 years (< 6 years): 6 or more upper or lower respiratory tract infections from October 2022 until the end of March 2023
• Age 6 to 18 years (≥ 6 years): 3 or more upper or lower respiratory tract infections from October 2022 until the end of March 2023

Study design:

International (Slovak republic, Czech republic, Serbia), multicentre (36), prospective, randomized, double-blind, placebo-controlled study

Primary endpoint:

To evaluate the effect of Imunoglukan P4H® chewable tablets (IMG®+ zinc+ vitamin D3) compared to the placebo group (zinc + vitamin D3) on:

• reduction in the number of RTIs episodes (total number)

Secondary endpoints:

To evaluate the effect of Imunoglukan P4H® chewable tablets (IMG®+ zinc+ vitamin D3) compared to the placebo group (zinc + vitamin D3) on:

• reduction in the number of episodes of RTI subtypes
• reduction in the duration of RTI episodes (total duration, RTI subtypes)
• reduction of the need for antibiotic (ATB) therapy
• reduction of the number of missed days at school/nursery due to RTI
• reduction of the number of missed working days due to RTIs
• reduction of the number of emergency department visits due to RTI
• reduction of the number of physician visits due to RTI
• tolerability and safety

Randomization:

• Active group: Imunoglukan P4H® chewable tablets (IMG® 50 mg + Zinc 5 mg + Vitamin D3 10 μg in 1 tablet):
• Placebo group: Placebo chewable tablets (Zinc 5 mg + Vitamin D 10 μg in 1 tablet) Dosage:
• up to 25 kg of body weight 1 tablet once a day for 3 months
• over 25 kg 2 tablets once a day for 3 months

Diagnostic procedures:

• Patient diary (Incidence and duration of RTIs)

Inclusion criteria

• signed informed consent
• age 3-18 years
• history of recurrent respiratory infections:

• Age 3 to 5 years (< 6 years): 6 or more upper or lower respiratory tract infections from October 2022 until the end of March 2023
• Ages 6 to 18 years (≥ 6 years): more than 3 upper or lower respiratory tract infections from October 2022 until the end of March 2023

Exclusion criteria

• refused informed consent
• bronchopulmonary dysplasia
• primary immunodeficiency
• cystic fibrosis
• chronic diarrhoea
• chronic diseases of the lungs, kidneys and liver
• malformations of the cardiovascular system
• oncological disease
• malnutrition
• intolerance to any of the ingredients in the study product
• taking preventive immunomodulatory therapy (beta-glucans, bacterial lysates, isoprinosine) less than 14 days prior enrolling the patient into the study