Probiotic specialist Bio-K has announced the findings from clinical research exploring the role of gut microbiome in children living with Autism Spectrum Disorder (ASD).
Initial findings indicate that daily consumption of a Bio-K+ probiotic drink by neurodivergent children was safe and well-tolerated.
Preliminary observations also suggested potential improvements in gastrointestinal (GI) symptoms, ASD-related behaviours and sleep patterns.
The study
The 30-week feasibility study included a 14-week supplementation period followed by a washout phase (a predefined, treatment-free interval that allows previous medication effects to dissipate and prevents "carryover" effects between treatments).
Participants consumed one daily serving of Bio-K+ probiotic.
Bio-K reported the following key observations:
- a strong safety and tolerability profile, with no adverse events reported
- high compliance among participants
- preliminary improvements in GI symptoms, behavioural outcomes and sleep patterns
- some observed 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 company stated that while the results were encouraging, the research is only a pilot study that is designed to assess feasibility and generate preliminary insights.
It added that larger, placebo-controlled trials are also needed to confirm efficacy and confirmed one was already underway: a randomised, triple-blind, placebo-controlled study initiated earlier this year.
Supported financially by CIHR and Kerry, the trial will enrol more than 120 children to evaluate the impact of Bio-K+ on behaviours, GI symptoms, brain function, sleep profile, faecal microbiome, 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 Dr Mathieu Millette, 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."