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Psychophysiological Effects of Lactobacillus Plantarum PS128 in Preschool Children With Autism Spectrum Disorder

Autism Clinical Trial

Official title:
Psychophysiological Effects of Lactobacillus Plantarum PS128 in Preschool Children With Autism Spectrum Disorder: a Randomized, Placebo-controlled Trial

Clinical Trial Summary

Autism Spectrum Disorders (ASD) comprises a complex group of disorders of neuronal development characterized by social and communication impairment along with presence of repetitive and restrictive behaviors. Emerging evidences support the gut-brain axis and further microbiota-gut-brain axis. Elevated prevalence of gastrointestinal (GI) dysfunction in individuals with ASD suggested that targeting gut may benefit patients with ASD. Lactobacillus plantarum PS128 (PS128) was reported to be a psychobiotic in several animal studies which modulated the levels of neurotransmitters in different brain areas. The current randomized, placebo-controlled trial was conducted to investigate the psychophysiological effects of PS128 in preschool children with ASD.

Clinical Trial Description

Emerging evidences support the gut-brain axis and further microbiota-gut-brain axis. Elevated prevalence of gastrointestinal (GI) dysfunction in individuals with ASD suggested that targeting gut may benefit patients with ASD. Lactobacillus plantarum PS128 (PS128) was reported to be a psychobiotic in several animal studies which modulated the levels of neurotransmitters in different brain areas. The current randomized, placebo-controlled trial was conducted to investigate the psychophysiological effects of PS128 in preschool children with ASD. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03982290
Study type Interventional
Source Mackay Memorial Hospital
Contact Hui-Ju Chen MD
Phone 02-25433535
Email hjuchen0623@gmail.com
Status Recruiting
Phase N/A
Start date October 1, 2018
Completion date December 2020
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