PS128 Successfully Targets Behavioral and Emotional Challenges in Autism Spectrum Disorder (ASD): Completion of Pivotal Clinical Trial on Preschool Children with ASD

SAN DIEGO, Jan. 25, 2024 /PRNewswire/ — A recent study published in the Research in Autism Spectrum Disorders unveils groundbreaking solutions for neurodevelopmental disorders. This is the first double-blinded, randomized, placebo-controlled trial aimed at exploring the impact of a single probiotic strain on behavioral changes in preschool children aged 2.5–7 years with autism spectrum disorder (ASD), specifically targeting the gut-brain axis (GBA). The primary objective was to determine treatment effects by assessing using questionnaires related to ASD, mood, and activity symptoms at various time points with the intervention of Lactobacillus plantarum PS128 (PS128) probiotic.

This trial enrolled 86 subjects and randomly allocated them in a 1:1 ratio to either the “PS128 early use group” (E group) or the “PS128 late use group” (L group). During the first stage, the E group received PS128, while the L group received placebo for 2 months. In the second stage, all subjects received PS128 for an additional 2 months. This trial demonstrated a significant reduction in anxious/depressed problems after taking two capsules of PS128 per day, providing a total of 6 × 10¹⁰ colony-forming units, for 2 months. The L group also showed notable improvement following 2 months of PS128 intervention in the second stage. These findings provide support for the notion that a brief 2-month intervention with a high dose of PS128 effectively improved certain internalizing issues in young children with ASD.

PS128 was proven to be a psychobiotic with neurotransmitter modulatory effects. Bened Life believes that PS128’s positive impact on alleviating ASD-related symptoms is connected to changes in the metabolism of dopamine and serotonin in the brain. This belief is supported by previous studies showing that PS128 influences the metabolism of dopamine and serotonin in various rodent models. PS128 may also enhance the effect through its potential influence on microbial diversity.

Leveraging the Gut-Brain Axis (GBA) for Neurological Disorders Management

The intricate connection between the nervous system and the gastrointestinal tract is recognized as the GBA. It comprises the linkage between the central nervous system (brain), the enteric nervous system (gut), and the microbiome residing in the gut (microbiota), facilitated by the circulatory system, immune system, and the vagus nerve. The bidirectional communication between the brain and gut occurs through various channels, including nerve signals, immune molecules, hormones, and microbial metabolites. This sophisticated network underscores the dynamic interplay between neurological and gastrointestinal elements.

Individuals with neurodevelopmental conditions like ASD often experience imbalances of neurotransmitters, especially in happy hormones serotonin or dopamine activity, possibly resulting from gut dysbiosis. Taking a neurologically active probiotic like PS128 may offer potential assistance in managing these imbalances. Previous clinical trials involving children and adolescents with ASD suggest a potential reduction in ASD-related neurological behaviors with the use of PS128, along with improvements in anxiety levels, shared attention, and communication skills. Other findings indicate that PS128 could offer benefits in alleviating attention deficit hyperactivity disorder (ADHD)-related symptoms without causing adverse effects. This contrasts with many ADHD medications known for their side effects, suggesting a potential advantage of PS128 in avoiding such problems.

The decline in dopamine levels is associated with the aggregation of ⍺-synuclein in brain neurons that leads to the depletion of dopamine-producing neurons and the onset of motor symptoms in Parkinson’s disease (PD). In addition to conventional treatment, individuals with PD experienced enhanced motor function and improved quality of life after supplementing with PS128 for 12 weeks. Notably, PS128 is considered safe to take alongside the usual dose of levodopa or other medications.

Furthermore, in a preliminary trial of PS128, there was a noteworthy amelioration in the severity of depression among individuals diagnosed with major depressive disorder.

Ongoing clinical trials are underway to uncover the unique position of neurobiotic PS128 in psychiatric disorders, seeking deeper insights to support and enhance mental well-being.

About Neurobiotics

Neurobiotics (or psychobiotics) offer a novel and low-risk alternative in providing comprehensive aid for individuals dealing with neurological conditions such as ASD and PD. Unlike common probiotics focused solely on digestion, neurobiotics encompass strains with neurological activity that support neurological health. Neurobiotic PS128 leverages the GBA to alleviate neurological symptoms associated with mood regulation, movement, learning, memory processes, and cognitive function. PS128 is safe for human supplementation, and no adverse events related to the PS128 intervention were found clinically.

About Bened Life

Bened Life is dedicated to providing science-backed, pharmaceutical-grade, gut-brain probiotics that support mental and neurological health. Neuralli Medical Probiotic, which contains the clinical dose of L. plantarum PS128, is a product attributed to the brand Bened Life. Visit benedlife.com to learn more about Neuralli.

Contact info
Name: Eva Lee
Email: international@benedlife.com