Lactobacillus plantarum PS128 on behavior activity of children with autism

Lactobacillus plantarum PS128 (PS128) is a recently reported psychobiotic. This trial aimed at investigating the effects of PS128 on behavior activity of children diagnosed with autism spectrum disorder (ASD). This trial will include 80 male subjects , aged from 7-15, who were diagnosed with ASD according to DSM-V and further confirmed diagnosis with Autism Diagnostic Interview-Revise (ADI-R). People who were prescribed to use antibiotics within 2 weeks or ingest probiotics products within 2 weeks will be excluded. Subjects will randomly assign to PS128 group or placebo group. After inclusion, the subjects will take PS128 (3 × 10^10 CFU) or placebo (microcrystalline cellulose) one capsule after breakfast and dinner (2 capsules per day) for 28 days. Symptoms improvement was evaluated on day 0 and on the endpoint. Clinical Global Impression-Severity (CGI-S) on day 0 and Clinical Global Impressions-Improvement (CGI-I) on day 28 were scored by principle investigator at examination room of clinic. Autism Behavior Checklist-Taiwan Version (ABCT), Social Responsiveness Scale (SRS), Child Behavior Checklist for Ages 6-18 (CBCL/6-18), and SNAP-IV parent rating scale were completed by parent of subjects on day 0 and day 28. Stool and urine samples were collected on day 0 and day 28.