Immunomodulatory Effect of Pleuran in Children With Recurrent Respiratory Tract Infections (IPRRTI)

Immunomodulatory Effect of Pleuran (β-glucan From Pleurotus Ostreatus) in Children With Recurrent Respiratory Tract Infections

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Tract Infection
• Intervention / Treatment: Dietary supplement: Imunoglukan P4H® chewable tablets; Dietary supplement: Placebo chewable tablets

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)

• Study Type: Interventional
• Enrollment (Actual): 217
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Praha, Czechia, 11000
    • IMUNOGLUKAN CZ, s.r.o.
• Serbia
  • Belgrade, Serbia, 11070
    • Medis Pharma d.o.o. Beograd
• Slovakia
  • Bratislava, Slovakia, 82105
    • Imunoglukan, s.r.o.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active group; Dietary supplement Imunoglukan P4H® chewable tablets (tablet containing IMG® 50 mg + Zinc 5 mg + Vitamin D 10 μg in 1 tablet) Dosage: up to 25 kg 1 tablet once daily for 3 months over 25 kg 2 tablets once daily for 3 months	Dietary supplement: Imunoglukan P4H® chewable tablets; IMG® 50 mg + Zinc 5 mg + Vitamin D 10 μg in 1 tablet
Placebo Comparator: Placebo group; Active Placebo Comparator (tablet containing 5 mg zinc + 10 μg vitamin D3) Dosage: up to 25 kg 1 tablet once daily for 3 months over 25 kg 2 tablets once daily for 3 months	Dietary supplement: Placebo chewable tablets; Zinc 5 mg + Vitamin D 10 μg in 1 tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in the number of RTIs episodes (total number)	number of episodes of respiratory infections will be compared between the two study goups	change in the number of RTIs episodes (total number) during 3 month supplementation (from enrollment to the end of the treatment at 3 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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 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)
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	monitoring the incidence of potential adverse events, incidence will be compared to placebo group	during 3 month supplementation (from enrollment to the end of the treatment at 3 months)

Collaborators and Investigators

• Sponsor: Pleuran, s.r.o.

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2023
• Primary Completion (Actual): March 31, 2024
• Study Completion (Actual): March 31, 2024

Study Registration Dates

• First Submitted: May 5, 2025
• First Submitted That Met QC Criteria: May 13, 2025
• First Posted (Actual): May 16, 2025

Study Record Updates

• Last Update Posted (Actual): May 16, 2025
• Last Update Submitted That Met QC Criteria: May 13, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: children; prevention; immunomodulation; beta-glucan; respiratory tract infection; pleuran
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Respiratory Tract Diseases; Infections; Communicable Diseases; Respiratory Tract Infections
• Other Study ID Numbers: IPRRTI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No