Bio-K+ Announces ‘Encouraging Findings’ in Ongoing Study of Microbiome Intervention in Children with Autism

Bio-K+, a specialist in probiotic solutions, announced encouraging preliminary findings in an ongoing clinical study exploring the role of the gut microbiome in children with Autism Spectrum Disorder (ASD).

The study was conducted in collaboration with researchers at the CHU Sainte-Justine Research Center in Montreal, and is supported by the Canadian Institutes of Health Research.

The initial findings suggest that daily consumption of a raspberry-flavored vegan Bio-K+ probiotic drink was safe and well-tolerated, potentially supporting improvements in gastrointestinal symptoms, ASD-related behaviors, and sleep patterns.

The 30-week study included a 14-week supplementation period followed by a washout phase, where participants each consumed one daily serving of Bio-K+.

Some of the improvements diminished after discontinuation, suggesting a potential link between ongoing microbiome support and sustained benefits. Parents also reported positive changes in appetite, sleep, and overall well-being.

The pilot study was designed to assess feasibility and generate preliminary insights, the company noted, and larger placebo-controlled trials are needed for confirmation.

With support from CIHR and Kerry, a randomized, triple blind, placebo-controlled study was initiated earlier this year. More than 120 children are expected to be enrolled to evaluate the impact of Bio-K+ on behavior, GI symptoms, brain function, sleep, fecal microbiome and metabolome, and blood chemistry in neurodivergent children.

“These findings contribute to an evolving understanding of the gut-brain connection and highlight the importance of continued research in this area,” said Matthieu Millette, PhD, scientific director of Bio-K+. “Up to 80% of neurodivergent children diagnosed with ASD experience significant GI challenges, underscoring the importance of exploring the microbiome’s role in their quality of life. The emerging evidence around Bio-K+ is promising and may help guide future approaches to supporting these children and their families.”