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

May 13, 2025 updated by: Pleuran, s.r.o.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
217

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
change in the number of RTIs episodes (total number)
Time Frame: 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
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
change in the number of episodes of RTI subtypes
Time Frame: 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 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)
Time Frame: 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 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
Time Frame: 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 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
Time Frame: 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 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
Time Frame: 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)
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
Time Frame: 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)
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
Time Frame: 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)
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
Time Frame: 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
during 3 month supplementation (from enrollment to the end of the treatment at 3 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pleuran, s.r.o.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 25, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 5, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 16, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 16, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Respiratory Tract Infection

Clinical Trials on Imunoglukan P4H® chewable tablets

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings