Clinical trial NCT06974747: Immunomodulatory Effect of Pleuran in Children With Recurrent Respiratory Tract Infections
Official title: Immunomodulatory Effect of Pleuran (β-glucan From Pleurotus Ostreatus) in Children With Recurrent Respiratory Tract Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Tract Infection
Keywords: pleuran
beta-glucan
immunomodulation
prevention
respiratory tract infection
children
Lead sponsor: Pleuran, s.r.o.
Sponsor class: INDUSTRY
First posted: 2025-05-16
Enrollment: 217
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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)

Eligibility criteria: 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

Primary outcomes:
measure: change in the number of RTIs episodes (total number)
timeFrame: 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:
measure: change in the number of episodes of RTI subtypes
timeFrame: change in the number of RTIs episodes (subtypes) during 3 month supplementation (from enrollment to the end of the treatment at 3 months)
measure: change in the duration of RTI episodes (total duration, RTI subtypes)
timeFrame: 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)
measure: change in the number of antibiotic therapy courses
timeFrame: change in the number of antibiotic (ATB) therapy courses during 3 month supplementation (from enrollment to the end of the treatment at 3 months)
measure: change of the number of missed days at school/nursery due to RTI
timeFrame: 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)
measure: change of the number of missed working days due to RTIs
timeFrame: 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)
measure: changeof the number of emergency department visits due to RTI
timeFrame: 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)
measure: change of the number of physician visits due to RTI
timeFrame: 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)
measure: tolerability and safety
timeFrame: during 3 month supplementation (from enrollment to the end of the treatment at 3 months)
Other outcomes:
Locations:
city: Praha
country: Czechia
facility: IMUNOGLUKAN CZ, s.r.o.
city: Belgrade
country: Serbia
facility: Medis Pharma d.o.o. Beograd
city: Bratislava
country: Slovakia
facility: Imunoglukan, s.r.o.
Study officials:
References: