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Status:

COMPLETED

Immunomodulatory Effect of Pleuran in Children With Recurrent Respiratory Tract Infections

Lead Sponsor:

Pleuran, s.r.o.

Conditions:

Respiratory Tract Infection

Eligibility:

All Genders

3-18 years

Phase:

NA

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 respi...

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 20...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    September 25 2023

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 31 2024

    Estimated Enrollment :

    217 Patients enrolled

    Trial Details

    Trial ID

    NCT06974747

    Start Date

    September 25 2023

    End Date

    March 31 2024

    Last Update

    May 16 2025

    Active Locations (3)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (3 locations)

    1

    IMUNOGLUKAN CZ, s.r.o.

    Prague, Czechia, 11000

    2

    Medis Pharma d.o.o. Beograd

    Belgrade, Serbia, 11070

    3

    Imunoglukan, s.r.o.

    Bratislava, Slovakia, 82105