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Lactobacillus plantarum PS128® on behavior activity of children with autism

2020 / 03 / 29

https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370984

 

https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370984

 

Sponsors and Collaborators

YuNing Psychiatry Clinic.

Investigators

Principal Investigator: Yu-Yu Wu, MD, YuNing Psychiatry Clinic. 

 

 

Brief Summary:


Psychobiotics is a group of probiotics which represents beneficial effects to mental health. Lactobacillus plantarum PS128® (PS128®) is a recently published 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).

 

Detailed Description:

 

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.