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

Last updated: June 10, 2019
Sponsor: Mackay Memorial Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Autism

Autism Spectrum Disorder (Asd)

Williams Syndrome

Treatment

N/A

Clinical Study ID

NCT03982290
17MMHIS193e
  • Ages 30-7
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Fulfill Diagnostic and Statistical Manual of Mental Disorders fifth version (DSM-V)criteria of Autism Spectrum Disorder

  • Do not take any other probiotics for at least 3 weeks before and during the studyperiod

Exclusion

Exclusion Criteria:

  • Autistic children with other neurodevelopmental disorders or psychiatric diseases

  • With a clinically significant chronic medical condition, including; anemia, brainmalformations, metabolic diseases, epilepsy, organic gastrointestinal disorders (i.e.gastroesophageal reflux, food allergies, irritable bowel syndrome (IBS)) and Celiacdisease

  • On anti-fungal, antibiotics, special diet (i.e. gluten-free diet, casein-free diet,high-protein diet, ketogenic diet) and current use of psychiatric medications withinthe preceding 3 weeks were excluded

  • Known allergy to probiotics

Study Design

Total Participants: 250
Study Start date:
October 01, 2018
Estimated Completion Date:
December 31, 2020

Study 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.

Connect with a study center

  • Department of Pediatric Neurology, MacKay Children's Hospital

    Taipei,
    Taiwan

    Active - Recruiting

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