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Clinical Study Highlights Improvements to Gut Microbiome and Autism Spectrum Disorder Symptoms with Use of Custom Probiotics

May 8, 2024, 07:46 AM by
Researchers with Sun Genomics and Arizona State University (ASU) have discovered that probiotic supplementation may improve symptoms in people with autism spectrum disorder. The joint metagenomics study assessed the effects of customized probiotic supplementation on children and adults with autism.

SAN DIEGO, May 7, 2024Researchers with Sun Genomicsand Arizona State University (ASU) have discovered that probiotic supplementation may improve symptoms in people with autism spectrum disorder. The joint metagenomics study assessed the effects of customized probiotic supplementation on children and adults with autism. 


Recently published in the journal mSystems, the research shows that customized probiotic supplementation based on the makeup of an individual’s gut microbiome, as well as certain dietary habits, may play an important role in improving the beneficial bacteria in the gut and may improve some behavioral symptoms associated with autism. 


Following the three-month clinical study, more than half of the participants reported moderate improvements in receptive language and comprehension, expressive language and speech, cognition and thinking and gastrointestinal problems after taking Flore, a personalized probiotic made by Sun Genomics 


“With participants reporting improvements in both autism spectrum disorder symptoms and gastrointestinal discomfort after the trial, we are pleased that our easily accessible solution had such a positive impact on their well-being,” said Sunny Jain, founder and chief executive officer of Floré. “Our research uncovered critical insight into the connection between precision nutrition – in the form of precision probiotics – and both gut health and autism spectrum disorder. We are hopeful that our joint research will lead to credible, less invasive solutions to improve symptoms and enhance the quality of life for so many around the world.”  


Additionally, certain dietary choices such as eating fruit appear to influence the composition of gut microbes, which could improve symptom management. For individuals who have autism and for their caregivers, changes in diet and adding probiotics may help improve overall quality of life. 


The clinical research was conducted with the participation of 296 children and adults diagnosed with autism spectrum disorder and 123 age-matched neurotypical controls. 170 participants completed the open-label study. 


Based on an analysis of their unique gut microbiota, each participant was given Floré customized probiotics that they used for three months or longer. They also completed a series of questionnaires including the Parent Global Impressions of Autism (PGIA); Gastrointestinal Symptom Rating Scale; and the Social Responsiveness Scale before taking the probiotics and repeated the questionnaires three months later. 

Key Findings:  

  • Gastrointestinal Improvement:According to the PGIA, 62% of individuals with autism spectrum disorder reported a reduction in gastrointestinal discomfort and improvement in overall autism-related symptoms. 

  • Behavioral and Autism Symptoms: Follow-up surveys revealed moderate improvement in thinking abilities, sensory experiences and overall autism-related symptoms among participants. 

  • Microbial Changes:Study participants who showed improvement had notable increases in beneficial bacteria (probiotics) in their gut over time. 

  • Diversity Findings: While there wasn't a significant overall difference in the variety of microbes (beta diversity) between groups (age, gender), there were notable changes in the diversity of microbes within individuals (alpha diversity). 

  • Relationship with Diet and Symptoms: Certain dietary habits, such as daily fruit consumption outside of the study, were associated with increases in microbial diversity and specific species. Additionally, custom probiotic supplements positively influenced gastrointestinal symptoms and overall autism-related issues. 

  • Dietary Impact on Microbes: The study also discovered significant variations in microbial composition between individuals who followed a gluten- and dairy-free diet and those who consumed these products. 


This collaborative clinical trial was conducted with ASU Professors James Adams and Rosa Krajmalnik-Brown. Adams leads the ASU Autism/Asperger's research program. The joint research team leveraged the success and findings of ASU’s 2019 autism research. An earlier 2017 studyshowed that Microbiota Transplant Therapy (MTT) greatly improved gut diversity in 18 children with autism. The most recent clinical trial conducted by Sun Genomics and ASU explored some available alternatives to their successful MTT work. 


“This is the largest metagenomics study of adults and children with autism spectrum disorder with an intervention targeting the microbiome,” said Krajmalnik-Brown, director of theBiodesign Center for Health Through Microbiomesat the ASU Biodesign Institute. “Although the results are preliminary, we hope to learn more about who potentially could be good candidates for this precision approach and learn which probiotic formulations work best to help more people.” 


As a result of the study’s findings, Sun Genomics is developing and beta-testing three custom Floré probiotic formulations for people with neurodiversity to help improve gastrointestinal symptoms and support mood, speech and neurological pathways. The next step is a randomized, double-blind and placebo-controlled study, which is needed to confirm the clinical study findings.