"I am different, not less."
- Dr. Temple Grandin
In 2016, one in every 54 children in the U.S. was diagnosed with autism, a number that keeps rising each year.
Challenges of Autism
Autism spectrum disorder (ASD) can present in many ways. Core symptoms include unique behaviors and obstacles to communication or social interaction.
Some children with autism are incredibly gifted, yet speaking or interacting with others is nearly impossible. Others struggle with hyperactivity or expressing emotions. When family or friends show them love and care, they are unable to respond positively, which can unfortunately lead to to strained relationships.
No treatment has been approved for the core symptoms of autism. We are hopeful at the positive clinical results PS128 has shown, which are described below.
PS128 vs. Other Probiotics
Type: open-label, double-arm, baseline-controlled study
Location: San Matteo Foundation (Pavia), Italy
Participants: 131 individuals with ASD, average age of 7, male and female
Participants received a daily dose of either PS128 or other probiotics for 6 months. Clinical Global Impression (CGI) scores based on a clinician’s overall assessment of each patient were collected before and after the treatment period.
Patients who improved from taking PS128
87% of the PS128 group showed improvement, while 40% of those taking other probiotics did.
Of the improved PS128 group, 34% were “very much improved” or “much improved.”
The most common benefits were
increased shared attention
reduced stereotyped (repetitive) movements, and
improved communication skills.
Improvement from taking PS128
Average CGI-Severity score of the PS128 group improved from "markedly ill" to "moderately ill."
The PS128 group's average improvement was more than twice of those taking other probiotics.
Very few side effects and no serious adverse events were reported.
Disease improvement after treatment
Significantly improved CGI-Improvement scores (measuring a clinician’s assessment of each patient’s improvement during the trial) were seen in those given both PS128 and oxytocin.
Participants taking only PS128 or oxytocin also improved much more than the placebo group.
SRS and ABC scores improved in subjects given PS128.
These benefits, as well as substantial increases in beneficial species of gut microbiota, suggest synergy between PS128 and oxytocin.
All treatment was well-tolerated, without serious adverse events.
PS128 + Oxytocin vs. Placebo
Type: randomized, placebo-controlled, double-blinded, two-stage pilot trial
Location: Massachusetts General Hospital, USA
Participants: 35 individuals with ASD, ages 3-20, male and female
Participants received a daily dose of either PS128 or a placebo for 28 weeks. Once 16 weeks had passed, daily nasal oxytocin therapy was added to the regimen of both groups.
They were evaluated at the beginning of the trial, at 16 weeks before oxytocin was added, and again at 28 weeks after the study finished. Social behaviors were measured by the Social Responsiveness Scale (SRS) and Aberrant Behavior Checklist (ABC). Assessments also included the Clinical Global Impression (CGI) scale, biomarkers, and fecal microbiome evaluations.
PS128 vs. Placebo
Type: randomized, placebo-controlled, double-blinded
Location: YuNing Psychiatry Clinic, Taiwan
Participants: 71 individuals with ASD, ages 7-15, male
Participants received a daily dose of either PS128 or a placebo for 4 weeks. They were evaluated at baseline and again after the study finished. Assessments included the Social Responsiveness Scale (SRS); the Autism Behavior Checklist-Taiwan version (ABC-T); the Child Behavior Checklist (CBCL); the Taiwan version of Swanson, Nolan, and Pelham-IV (SNAP-IV); and the Clinical Global Impression (CGI) scale.
Opposition, defiance, and other autism-related behaviors were improved.
The SNAP-IV scale measures core symptoms of attention-deficit/hyperactivity disorder and oppositional defiant disorder. Changes in the scores of younger children (ages 7-12) taking PS128 daily for four weeks were compared with their placebo counterparts. Significantly lower (improved) scores were found in the PS128 group, suggesting that the psychobiotic helped alleviate their behavioral symptoms.
Improvements in social communication and interaction, restricted interests, and repetitive behaviors were seen.
The SRS gauges social communication, awareness, and emotions, as well as limited interests and repetitious actions typical to autism.
Assessments at baseline and again after four weeks of treatment showed significant improvement for those children given PS128.
Anxiety levels were reduced.
A wide range of behaviors are evaluated using the Child Behavior Checklist.
Significantly decreased levels of anxiousness were shown by those who took PS128 during the trial.
No adverse events were reported during the study
Probiotics and Autism
Our gut, which contains around 100 million neurons, is often called our “second brain,” and these enteric nerve cells can function independently of our central nervous system (CNS). These two neural networks frequently communicate with and influence each other, and when neurological development is impaired, GI health can suffer. For example, children with an ASD have higher rates of gastrointestinal (GI) symptoms such as diarrhea, constipation, or abdominal pain, than do children of typical neurological development.
This interaction between our two “brains” has been found to not only take place directly via neural transmission but also through endocrine, immune, and metabolic pathways.
Martha Herbert, a leading autism researcher at Harvard Medical School, used MRI scans to examine the neural anatomy of children with autism. She found their brains were full of activated immune cells and inflammatory molecules, contributing to the chronic neuroinflammation often seen in those with ASD. In a paper reporting her findings, she proposed that autism disorders are not primarily caused by brain abnormalities but actually influenced by multiple body systems, including the digest and immune systems .
Gut Microbiota and Autism
Gut-brain axis research has led to understanding of a direct, reciprocal influence that exists between GI tract microbiota and the CNS, including nervous system disorders such as autism, Parkinson’s, depression, and anxiety.
Regarding autism specifically, the gut microflora of individuals with an ASD is unique when compared to those without. Autism patients have a higher proportion of Firmicutes bacteria and relatively fewer Bacteroides. This has led to scientists asking whether gut microbe modification could lead to CNS improvements and neurological disorder treatments .
Treating Autism Via the Microbiome
Researcher Elaine Hsiao showed how this microbiome-gut-brain connection can influence ASD-like symptoms in mice . Knowing that immune cells and inflammatory cytokines in the brain contribute to autism symptoms , Hsiao’s team mimicked an infection to activate the immune systems of pregnant mice. Soon after, the newborn pups exhibited both autism-like behaviors (anxiety, repetitive behaviors, and impaired social interaction) and GI tract symptoms (atypical, imbalanced gut microbes and intestinal permeability.)
Notably, after the pups were treated with Bacteroides from a human gut, their intestinal walls became more stable and blood data showed a decrease in a substance (4EPS) that induced their anxiety-like symptoms. Post-treatment, not only were the pups’ gut microbiomes more like those of a healthy mouse, but their symptoms of anxiety, repetitive behavior, and social impairment were also attenuated.
PS128 Is Helping
After being ingested, PS128 begins to play an active role in our microbiome. Though the functional mechanisms are not yet fully understood, it likely stimulates our microbiota-gut-brain axis to regulate neural, endocrine, immune, and metabolic pathways, thus improving symptoms of ASD. These benefits may be specifically due to PS128's unique ability to modulate levels of dopamine, serotonin, and short-chain fatty acids .
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