Improvement of sleep and melatonin in children with autism spectrum disorder after β‐1,3/1,6‐glucan consumption: An open‐label prospective pilot clinical study

This clinical study evaluates AFO-202 strain AP-beta-glucan in children with Autism Spectrum Disorder (ASD) — a condition where immune dysregulation and neuroinflammation are increasingly recognized as key factors, not merely behavioral manifestations.

Key findings:

• Significant improvement in behavioral assessment scores (CARS and ABC behavioral scales)
• Improved sleep quality — a major quality-of-life concern for ASD families
• Reduced serum α-synuclein levels — a neuroinflammatory biomarker also elevated in Parkinson's disease
• AFO-202 strain demonstrated safety and tolerability in pediatric population

Significance: The reduction in α-synuclein is a particularly important biomarker finding. Elevated α-synuclein indicates neuroinflammation and protein aggregation associated with neurodegeneration. AP-beta-glucan's ability to reduce this marker suggests neuroprotective immunomodulation via the gut-brain axis. Given the critical role of gut microbiome in ASD and the documented prebiotic effects of AP-glucan, this mechanism is biologically plausible. This positions AP-glucan as a scientifically grounded, natural adjunct for ASD behavioral management.