Respiratory Tract Infection
Conditions
Keywords
pleuran, beta-glucan, immunomodulation, prevention, respiratory tract infection, children
Brief summary
International, multicentre, prospective, randomized, double-blind, placebo-controlled study with a food supplement Imunoglukan P4H® chewable tablets to evaluate preventive effect on reduction of respiratory tract infections (RTIs) in children with a history of recurrent respiratory tract infections (RRTIs) in the previous infectious season prior enrolment. Participants or their guardians will record the incidence and duration of RTIs in the Patient diary for 3 months.
Detailed description
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)
Interventions
DIETARY_SUPPLEMENTImunoglukan P4H® chewable tablets
IMG® 50 mg + Zinc 5 mg + Vitamin D 10 μg in 1 tablet
DIETARY_SUPPLEMENTPlacebo chewable tablets
Zinc 5 mg + Vitamin D 10 μg in 1 tablet
Sponsors
Pleuran, s.r.o.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in the number of RTIs episodes (total number) | change in the number of RTIs episodes (total number) during 3 month supplementation (from enrollment to the end of the treatment at 3 months) | number of episodes of respiratory infections will be compared between the two study goups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in the duration of RTI episodes (total duration, RTI subtypes) | change in the duration of RTIs episodes (total duration, subtypes) during 3 month supplementation (from enrollment to the end of the treatment at 3 months) | — |
| change in the number of antibiotic therapy courses | change in the number of antibiotic (ATB) therapy courses during 3 month supplementation (from enrollment to the end of the treatment at 3 months) | — |
| change of the number of missed days at school/nursery due to RTI | change of the number of missed days at school/nursery due to RTI during 3 month supplementation (from enrollment to the end of the treatment at 3 months) | — |
| change in the number of episodes of RTI subtypes | change in the number of RTIs episodes (subtypes) during 3 month supplementation (from enrollment to the end of the treatment at 3 months) | — |
| changeof the number of emergency department visits due to RTI | changeof the number of emergency department visits due to RTI during 3 month supplementation (from enrollment to the end of the treatment at 3 months) | — |
| change of the number of physician visits due to RTI | change of the number of physician visits due to RTI during 3 month supplementation (from enrollment to the end of the treatment at 3 months) | — |
| tolerability and safety | during 3 month supplementation (from enrollment to the end of the treatment at 3 months) | monitoring the incidence of potential adverse events, incidence will be compared to placebo group |
| change of the number of missed working days due to RTIs | change of the number of missed working days due to RTIs during 3 month supplementation (from enrollment to the end of the treatment at 3 months) | — |
Countries
Czechia, Serbia, Slovakia
Outcome results
None listed