Respiratory Tract InfectionIPRRTINCT06974747
Immunomodulatory Effect of Pleuran in Children With Recurrent Respiratory Tract Infections
A study testing Imunoglukan P4H® chewable tablets in people with Respiratory Tract Infection, run by Pleuran, s.r.o. at 3 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Respiratory Tract Infection
- What is being tested?
- Imunoglukan P4H® chewable tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 217 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 25 Sep 2023to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- refused informed consent
- bronchopulmonary dysplasia
- primary immunodeficiency
- cystic fibrosis
- chronic diarrhoea
- chronic diseases of the lungs, kidneys and liver
Show all 11Show fewer
- 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
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: 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.
Read the 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)
- Conditions
- Respiratory Tract Infection
- Being tested
- Imunoglukan P4H® chewable tablets, Placebo chewable tablets
- Keywords
- pleuran, beta-glucan, immunomodulation, prevention, respiratory tract infection, children
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imunoglukan P4H® chewable tabletsDietary supplement
IMG® 50 mg + Zinc 5 mg + Vitamin D 10 μg in 1 tablet
Placebo chewable tabletsDietary supplement
Zinc 5 mg + Vitamin D 10 μg in 1 tablet
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Dietary Supplement: Placebo chewable tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in the number of RTIs episodes (total number)
number of episodes of respiratory infections will be compared between the two study goups
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: during 3 month supplementation (from enrollment to the end of the treatment at 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start25 Sep 2023
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pleuran, s.r.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06974747
- Sponsor's protocol ID
- IPRRTI
- Acronym
- IPRRTI
- Status last verified
- May 2025
- First submitted
- 5 May 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41085920
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunomodulatory Effect of Pleuran (β-glucan From Pleurotus Ostreatus) in Children With Recurrent Respiratory Tract Infections
- ClinicalTrials.gov ID
- NCT06974747
- Acronym / sponsor ID
- IPRRTI / IPRRTI
- Conditions
- Respiratory Tract Infection
- Keywords
- pleuran, beta-glucan, immunomodulation, prevention, respiratory tract infection, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Pleuran, s.r.o.Industry (pharma, biotech, devices)
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active group | Experimental | Dietary Supplement: Imunoglukan P4H® chewable tabletsDietary 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 |
| Placebo group | Placebo comparator | Dietary Supplement: Placebo chewable tabletsActive 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 |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- signed informed consent
- age 3-18 years
- history of recurrent respiratory infections:
Key exclusion criteria (11 listed)
- refused informed consent
- bronchopulmonary dysplasia
- primary immunodeficiency
- cystic fibrosis
- chronic diarrhoea
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imunoglukan P4H® chewable tabletsIMG® 50 mg + Zinc 5 mg + Vitamin D 10 μg in 1 tablet | Dietary supplement | Active group |
| Placebo chewable tabletsZinc 5 mg + Vitamin D 10 μg in 1 tablet | Dietary supplement | Placebo group |
Primary outcome
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
8 secondary outcomes
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 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 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 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 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)
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)
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)
tolerability and safety
Time frame: during 3 month supplementation (from enrollment to the end of the treatment at 3 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Derived from this study: PubMed 41085920Jesenak 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.
Related trials for Respiratory Tract Infection
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingObservational study
VIRal Pulmonary Infections in Older AGE
Viral Pulmonary Infections
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imunoglukan P4H® chewable tablets in people with Respiratory Tract Infection, run by Pleuran, s.r.o. at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Czechia, Serbia, Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06974747, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.