Immunomodulatory Effect of Pleuran in Children With Recurrent Respiratory Tract Infections

NCT06974747 | Completed

• 1 other identifier: IPRRTI
• Study Type: interventional
• Target: 217
• Locations: 3 countries
• Sites: 3

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.

Conditions

Respiratory Tract Infection

Keywords

pleuran; beta-glucan; immunomodulation; prevention; respiratory tract infection; children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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)

Study Arms (2)

Active group

EXPERIMENTAL

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

Placebo group

PLACEBO COMPARATOR

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

Interventions

Imunoglukan P4H® chewable tablets DIETARY_SUPPLEMENT

IMG® 50 mg + Zinc 5 mg + Vitamin D 10 μg in 1 tablet

Active group

Placebo chewable tablets DIETARY_SUPPLEMENT

Zinc 5 mg + Vitamin D 10 μg in 1 tablet

Placebo group

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pleuran, s.r.o.: lead

Study Sites (3)

IMUNOGLUKAN CZ, s.r.o.

Prague, 11000, Czechia

Location

Medis Pharma d.o.o. Beograd

Belgrade, 11070, Serbia

Location

Imunoglukan, s.r.o.

Bratislava, 82105, Slovakia

Location

Related Publications (1)

• Jesenak M, Prokopova E, Bozensky J, Bonaci-Nikolic B, Milosevic K, Stankovic K, Ostojic O, Zivkovic Z, Diamant Z, Kunc P, Janeczek K, Majtan J. Novel Chewable Pleuran-Based Supplement Decreases Respiratory Tract Infections in Children: A Randomised Controlled Trial. Adv Ther. 2025 Dec;42(12):6132-6149. doi: 10.1007/s12325-025-03393-3. Epub 2025 Oct 14.

  PMID: 41085920 DERIVED

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 16, 2025
• Study Start: September 25, 2023
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: May 16, 2025

Record last verified: 2025-05

Locations

SL (1); CZ (1); SE (1)