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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
250
PS128 capsules, 2 capsules per day
Placebo capsules, 2 capsules per day
Department of Pediatric Neurology, MacKay Children's Hospital
Taipei, Taiwan
RECRUITINGChanges from baseline of anxiety subscale in Children's Behavior Checklist (CBCL)/Achenbach System of Empirically Based Assessment (ASEBA) at week 8 and week 16
ASEBA for behavioral assessment
Time frame: Baseline, week 8 and week 16
Changes from hyperactivity subscale of Attention-Deficit/Hyperactivity Disorder Test (ADHDT) at week 8 and week 16
Inattention, hyperactive symptoms evaluation
Time frame: Baseline, week 8 and week 16
Gastrointestinal symptoms recorded by using GI Severity Index (6-GSI) at week 8 and week 16
constipation, diarrhea, stool consistency, stool smell, flatulence, and abdominal pain
Time frame: Baseline, week 8 and week 16
Change of total scores at week 8 and week 16 from baseline of Changes of Childhood Asperger Syndrome Test (CAST)
CAST for behavioral assessment
Time frame: Baseline, week 8 and week 16
Change of total scores at week 8 and week 16 from baseline of Penn Interactive Peer Play Scale, (PIPPS)
PIPPS for communicative and interactive assessment
Time frame: Baseline, week 8 and week 16
Change of total scores at week 8 and week 16 from baseline of Social Interaction Assessment Scale
Communicative and interactive assessment
Time frame: Baseline, week 8 and week 16
Comparison of Microbiota composition between week 8 and baseline
Gut and oral microbiota analysis
Time frame: Baseline and week 8
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