By: Mathieu Millette, Ph.D., Mcb.A., and Riham Zahra, MS Consider being a parent of a child with autism spectrum disorder (ASD), facing daily challenges while searching for solutions to improve your child's quality of life. Every day brings uncertainty, but also hope and determination. This blog highlights a new clinical trial exploring the potential of a specific probiotic formulation, Bio-K+TM, to create positive changes in the lives of children with ASD. ASD is a group of heterogeneous neurodevelopmental disorders characterized by restricted, repetitive patterns of behavior and deficits in communication and social interaction (1). The global prevalence of ASD is estimated to be between 1% and 2% (2). In Canada, 1 in 50 (2%) children and youth under the age of 17 are diagnosed with ASD (3) while in the United States, the latest report states that 1 in 36 children has autism (4). Children with ASD frequently experience co-occurring conditions such as anxiety, gastrointestinal (GI) issues, and sleep disturbances. Emerging research suggests a link between gut microbiota and ASD symptoms, prompting growing probiotic interventions (5). The gut microbiome, composed of trillions of microorganisms in the digestive tract, plays a crucial role in overall health. Studies have found that children with ASD often have a distinct gut microbiota composition to neurotypical individuals. This altered microbiome is associated with a higher prevalence of GI issues such as constipation, diarrhea, bloating, and abdominal pain. These GI symptoms can significantly impact the quality of life for children with ASD and their families, potentially worsening existing behavioral challenges and sleep disturbances (5). The gut microbiome and autism are believed to be linked through the gut-brain axis, a two-way communication system between the gut and brain. Disruptions in gut health can influence neurodevelopmental outcomes and behavioral symptoms in individuals with ASD. For example, improvements in gut health through dietary modifications or the use of probiotics and prebiotics have been linked to positive behavioral changes (6). This has led researchers to hypothesize that restoring microbial balance in the gut may help alleviate some core symptoms of autism. Study Overview A multidisciplinary team—led by Dr. Valérie Marcil and Dr. Ghizlane Gaougaou from the Research Centre of the CHU Sainte-Justine in Montreal, Quebec, Canada—recently conducted a 30-week feasibility study. Their goal was to evaluate the acceptability, safety, and preliminary impact of Bio-K+TM, a raspberry-flavored vegan probiotic beverage, in children aged 4 to 11 diagnosed with ASD. The study assessed the feasibility of the research protocol and gathered preliminary data on the probiotic's effects on ASD-related behaviors, GI symptoms, and sleep disorders. Researchers also analyzed fecal microbiome composition, blood and fecal metabolomes, and dietary intake during the clinical trial. A total of 23 children with ASD were recruited through social media and medical records. Baseline characteristics were assessed 8 weeks before treatment. Participants consumed one bottle (98 g) of Bio-K+TM daily for 14 weeks, followed by an 8-week washout period. Researchers measured feasibility by assessing recruitment, compliance, and completion rates. To evaluate the preliminary impact of probiotic supplementation, they used tools such as the Autism Treatment Evaluation Checklist (ATEC), the GI Severity Index (GSI), and sleep questionnaires. The results were highly promising. All participants accepted the probiotic beverage, and no adverse events were reported, confirming its safety and tolerability. The study met pre-established benchmarks for recruitment, compliance, and data collection, demonstrating the feasibility of the research protocol. Additionally, preliminary findings suggested improvements in ASD-related behaviors, GI symptoms, and sleep patterns. Notably, the ATEC score decreased by 42.8%, while the GSI score showed a 66% reduction after 14 weeks of supplementation. However, these improvements returned to baseline following the washout phase, highlighting the potential benefits of continuous probiotic use. One of the most significant findings of this study was its impact on quality of life. Parents reported notable improvements in their children's behavior, appetite, sleep, and digestive health after probiotic supplementation. Conclusion The study confirmed that Bio-K+TM supplementation is safe, well-tolerated, and feasible for children with ASD. Preliminary data suggest potential benefits in behavioral symptoms and GI health, although researchers emphasize the need for larger, placebo-controlled studies to validate these findings and establish efficacy. For Kerry Group, parent company of Bio-K+TM, this study represents the first step in its mission to develop clinically supported solutions for children with ASD. These efforts aim to address common challenges that significantly affect both children and their families with daily activities. John Elder Robison (Look Me in the Eye, 2007) and Dena Gassner wrote, “There is no epidemic of autism. Instead, what we face is an epidemic of need.” Both are autistic and parents of autistic adults. They serve on the Interagency Autism Coordinating Committee (IACC), which oversees the U.S. government’s Strategic Plan for Autism for. As scholars and advocates, they stress the importance of recognizing and addressing these needs. For parents and caregivers, this study offers a glimmer of hope and an important step forward in improving the quality of life for children with ASD. References 1. American Psychiatric Association. 2022. Diagnostic and statistical manual of mental disorders (5th ed., text rev.). 2. Lai MC, Lombardo MV, Baron-Cohen S. 2014. Autism. Lancet. 383(9920):896-910. 3. Canada PHAo. Autism spectrum disorder: Highlights from the 2019 Canadian health survey on children and youth. https://www.canada.ca/content/dam/phac-aspc/documents/services/publications/diseases-conditions/autism-spectrum-disorder-canadian-health-survey-children-youth-2019/autism-spectrum-disorder-canadian-health-survey-children-youth-2019.pdf. 4. Maenner MJ, Warren Z, Williams AR, et al. 2023. Prevalence and Characteristics of Autism Spectrum Disorder Among Children Aged 8 Years — Autism and Developmental Disabilities Monitoring Network, 11 Sites, United States, 2020. MMWR Surveill Summ. 72(No. SS-2):1–14. 5. Socała et al. 2021. The role of microbiota-gut-brain axis in neuropsychiatric and neurological disorders. Pharmacological Research.172:105840. 6. Barba-Villa et al. 2025. Probiotics in autism spectrum disorders: a systematic review of clinical studies and future directions. Nutrition Reviews. 83(2):329-343.
