Novel Chewable Pleuran-Based Supplement Decreases Respiratory Tract Infections in Children: A Randomised Controlled Trial
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064190%3A_____%2F25%3A10001427" target="_blank" >RIV/00064190:_____/25:10001427 - isvavai.cz</a>
Alternative codes found
RIV/00216208:11110/25:10504363
Result on the web
<a href="https://doi.org/10.1007/s12325-025-03393-3" target="_blank" >https://doi.org/10.1007/s12325-025-03393-3</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1007/s12325-025-03393-3" target="_blank" >10.1007/s12325-025-03393-3</a>
Alternative languages
Result language
angličtina
Original language name
Novel Chewable Pleuran-Based Supplement Decreases Respiratory Tract Infections in Children: A Randomised Controlled Trial
Original language description
IntroductionRecurrent respiratory tract infections (RRTIs) are common in childhood and impose substantial socioeconomic burden. beta-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.MethodsThis 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 (R) 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.ResultsIn 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.ConclusionChewable 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 RegistrationClinicalTrials.gov ID NCT06974747.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30104 - Pharmacology and pharmacy
Result continuities
Project
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Continuities
V - Vyzkumna aktivita podporovana z jinych verejnych zdroju
Others
Publication year
2025
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
ADVANCES IN THERAPY
ISSN
0741-238X
e-ISSN
1865-8652
Volume of the periodical
42
Issue of the periodical within the volume
12
Country of publishing house
US - UNITED STATES
Number of pages
18
Pages from-to
6132-6149
UT code for WoS article
001592783200001
EID of the result in the Scopus database
2-s2.0-105018769716