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

IF 4 3区医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL

Advances in Therapy Pub Date : 2025-10-14 DOI:10.1007/s12325-025-03393-3

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

{"title":"Novel Chewable Pleuran-Based Supplement Decreases Respiratory Tract Infections in Children: A Randomised Controlled Trial.","authors":"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","doi":"10.1007/s12325-025-03393-3","DOIUrl":null,"url":null,"abstract":"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.","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.0000,"publicationDate":"2025-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Advances in Therapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s12325-025-03393-3","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}

引用次数: 0

Abstract

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.

查看原文本刊更多论文

一项随机对照试验：新型可咀嚼胸膜补充剂可减少儿童呼吸道感染。

反复呼吸道感染（RRTIs）在儿童中很常见，并造成了巨大的社会经济负担。β-葡聚糖，特别是来自平菇的胸脯聚糖，通过病原体相关的分子模式受体相互作用显示出免疫调节特性。本研究评估了一种新的含维生素D和锌的可咀嚼胸脯酸补充剂，用于预防RRTIs儿童呼吸道感染。方法：这项国际、多中心、随机、双盲、安慰剂对照试验纳入了来自斯洛伐克、捷克共和国和塞尔维亚的249名rrti儿童。在呼吸道感染季节（10月至3月），参与者接受为期3个月的以胸膜为基础的补充剂（含维生素D和锌的IMG®）或活性安慰剂（维生素D和锌）。主要终点为全呼吸道感染（RTIs）。次要终点包括RTI亚型、RTI持续时间、缺课天数和安全性评估。结果：总共有217名儿童完成了研究（104名有效，113名安慰剂）。与安慰剂组相比，活跃组总rti显著减少（2.35±1.25 vs 2.77±1.78;P = 0.042）， 3个月减少15.2%。普通感冒发作次数减少18.6%（1.53±1.22∶1.88±1.25;P = 0.040）。在6岁以上的儿童中效果显著（总rti P = 0.026；普通感冒P = 0.005），第一个月后效果明显（P = 0.037）。扁桃体咽炎的发生频率（P = 0.003）和持续时间（P = 0.009）显著减少。在呼吸季节开始时入组的儿童的事后分析证实，普通感冒的频率（P = 0.004）和持续时间（P = 0.023）显著减少。该补充剂表现出良好的耐受性，98.7%的依从性，只有轻微的不良事件。结论：含维生素D和锌的咀嚼胸脯酸补充剂可显著减少RRTIs儿童呼吸道感染，具有快速起效和良好的安全性，在这一易感人群中显示出治疗潜力。试验注册：ClinicalTrials.gov ID NCT06974747。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Advances in Therapy 医学-药学

CiteScore

7.20

自引率

2.60%

发文量

353

审稿时长

6-12 weeks

期刊介绍： Advances in Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Advances in Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.