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

Area of Science:

• Immunology
• Pediatrics
• Nutritional Science

Background:

• Recurrent respiratory tract infections (RRTIs) are a significant health concern in children, leading to substantial socioeconomic burdens.
• Beta-glucans, like pleuran from Pleurotus ostreatus, possess immunomodulatory properties via pathogen-associated molecular pattern receptor interactions.
• This study investigated a new chewable supplement combining pleuran, vitamin D, and zinc for preventing respiratory infections in children diagnosed with RRTIs.

Purpose of the Study:

• To evaluate the efficacy of a novel pleuran-based supplement with vitamin D and zinc in preventing respiratory tract infections (RTIs) in children experiencing recurrent RTIs (RRTIs).
• To assess secondary endpoints including RTI subtypes, duration, school absenteeism, and safety.
• To determine the onset of action and safety profile of the supplement in a pediatric population with RRTIs.

Main Methods:

• An international, multicenter, randomized, double-blind, placebo-controlled trial was conducted with 249 children diagnosed with RRTIs across Slovakia, Czech Republic, and Serbia.
• Participants received either a pleuran-based supplement (IMG® with vitamin D and zinc) or an active placebo (vitamin D and zinc) for three months during the respiratory infection season (October-March).
• The primary endpoint was the total number of respiratory tract infections (RTIs), with secondary endpoints focusing on RTI subtypes, duration, missed school days, and safety assessments.

Main Results:

• The study included 217 children (104 active, 113 placebo) who completed the trial. The active supplement group showed a statistically significant reduction in total RTIs compared to the placebo group (15.2% reduction over 3 months; P=0.042).
• Significant reductions were observed in common cold episodes (18.6%; P=0.040), particularly in children over 6 years old. Tonsillopharyngitis frequency and duration were also significantly decreased (P=0.003 and P=0.009, respectively).
• The supplement demonstrated a rapid onset of action, with effects evident after the first month. It was well-tolerated, with 98.7% compliance and only mild adverse events reported.

Conclusions:

• The chewable pleuran-based supplement containing vitamin D and zinc significantly reduced the incidence of respiratory tract infections in children with RRTIs.
• The intervention exhibited a rapid onset of therapeutic effect and a favorable safety profile, indicating its potential as a preventative measure.
• This supplement represents a promising therapeutic option for managing and preventing respiratory infections in the vulnerable pediatric population experiencing RRTIs.