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Introduction <p>Recurrent respiratory tract infections (RRTIs) are common in childhood and impose substantial socioeconomic burden. β-Glucans, particularly pleuran from <i>Pleurotus ostreatus</i>, demonstrate immunomodulatory properties through the pathogen-associated molecular pattern receptor interactions. This study evaluated a novel chewable pleuran-based supplement with vitamin&#xa0;D and zinc for preventing respiratory infections in children with RRTIs.</p> Methods <p>This international, multicentre, randomised, double-blind, placebo-controlled trial enrolled 249 children with RRTIs from Slovakia, Czech Republic, and Serbia. Participants received either pleuran-based supplement (IMG® with vitamin&#xa0;D and zinc) or active placebo (vitamin&#xa0;D and zinc) for 3&#xa0;months during respiratory infection season (October–March). Primary endpoint was total respiratory tract infections (RTIs). Secondary endpoints included RTI subtypes, RTI duration, missed school days, and safety evaluations.</p> Results <p>In total, 217 children completed the study (104 active, 113 placebo). The active group experienced significantly fewer total RTIs versus placebo (2.35 ± 1.25 vs. 2.77 ± 1.78; <i>P</i> = 0.042), representing 15.2% reduction over 3&#xa0;months. Common cold episodes were reduced by 18.6% (1.53 ± 1.22 vs. 1.88 ± 1.25; <i>P</i> = 0.040). Effects were pronounced in children over 6&#xa0;years (<i>P</i> = 0.026 for total RTIs; <i>P</i> = 0.005 for common cold) and evident after the first month (<i>P</i> = 0.037). Tonsillopharyngitis showed significant reductions in frequency (<i>P</i> = 0.003) and duration (<i>P</i> = 0.009). Post hoc analysis of children enrolled at respiratory season onset confirmed significant reductions in common cold frequency (<i>P</i> = 0.004) and duration (<i>P</i> = 0.023). The supplement demonstrated excellent tolerability with 98.7% compliance and only mild adverse events.</p> Conclusion <p>Chewable pleuran-based supplement with vitamin&#xa0;D and zinc significantly reduced respiratory tract infections in children with RRTIs, with rapid onset and favourable safety profile, demonstrating therapeutic potential in this vulnerable population.</p> Trial Registration <p>ClinicalTrials.gov ID NCT06974747.</p>

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Novel Chewable Pleuran-Based Supplement Decreases Respiratory Tract Infections in Children: A Randomised Controlled Trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年10月14日

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  • Milos Jesenak,
  • Elena Prokopova,
  • Jan Bozensky,
  • Branka Bonaci-Nikolic,
  • Katarina Milosevic,
  • Katarina Stankovic,
  • Olivera Ostojic,
  • Zorica Zivkovic,
  • Zuzana Diamant,
  • Peter Kunc,
  • Kamil Janeczek,
  • Juraj Majtan

摘要

Introduction

Recurrent respiratory tract infections (RRTIs) are common in childhood and impose substantial socioeconomic burden. β-Glucans, particularly pleuran from Pleurotus ostreatus, demonstrate immunomodulatory properties through the pathogen-associated molecular pattern receptor interactions. This study evaluated a novel chewable pleuran-based supplement with vitamin D and zinc for preventing respiratory infections in children with RRTIs.

Methods

This international, multicentre, randomised, double-blind, placebo-controlled trial enrolled 249 children with RRTIs from Slovakia, Czech Republic, and Serbia. Participants received either pleuran-based supplement (IMG® with vitamin D and zinc) or active placebo (vitamin D and zinc) for 3 months during respiratory infection season (October–March). Primary endpoint was total respiratory tract infections (RTIs). Secondary endpoints included RTI subtypes, RTI duration, missed school days, and safety evaluations.

Results

In total, 217 children completed the study (104 active, 113 placebo). The active group experienced significantly fewer total RTIs versus placebo (2.35 ± 1.25 vs. 2.77 ± 1.78; P = 0.042), representing 15.2% reduction over 3 months. Common cold episodes were reduced by 18.6% (1.53 ± 1.22 vs. 1.88 ± 1.25; P = 0.040). Effects were pronounced in children over 6 years (P = 0.026 for total RTIs; P = 0.005 for common cold) and evident after the first month (P = 0.037). Tonsillopharyngitis showed significant reductions in frequency (P = 0.003) and duration (P = 0.009). Post hoc analysis of children enrolled at respiratory season onset confirmed significant reductions in common cold frequency (P = 0.004) and duration (P = 0.023). The supplement demonstrated excellent tolerability with 98.7% compliance and only mild adverse events.

Conclusion

Chewable pleuran-based supplement with vitamin D and zinc significantly reduced respiratory tract infections in children with RRTIs, with rapid onset and favourable safety profile, demonstrating therapeutic potential in this vulnerable population.

Trial Registration

ClinicalTrials.gov ID NCT06974747.