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

PLEURAN, s.r.o.

Status: Completed

Conditions: Respiratory Tract Infection

Treatments: Dietary Supplement: Imunoglukan P4H® chewable tablets; Dietary Supplement: Placebo chewable tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT06974747

IPRRTI

Details and patient eligibility

About

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.

Full 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)

Enrollment: 217 patients

Sex: All

Ages: 3 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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217 participants in 2 patient groups, including a placebo group

Active group

Experimental group

Description:

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

Treatment:

Dietary Supplement: Imunoglukan P4H® chewable tablets

Placebo group

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo chewable tablets