Psychophysiological Effects of Lactobacillus Plantarum PS128 in Preschool Children With Autism Spectrum Disorder: a Randomized, Placebo-controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Autism
- Sponsor
- Mackay Memorial Hospital
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- Changes from baseline of anxiety subscale in Children's Behavior Checklist (CBCL)/Achenbach System of Empirically Based Assessment (ASEBA) at week 8 and week 16
- Last Updated
- 6 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Hui-Ju Chen
Senior Attending Physician
Mackay Memorial Hospital
Eligibility Criteria
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 study period
Exclusion Criteria
- •Autistic children with other neurodevelopmental disorders or psychiatric diseases
- •With a clinically significant chronic medical condition, including; anemia, brain malformations, metabolic diseases, epilepsy, organic gastrointestinal disorders (i.e. gastroesophageal reflux, food allergies, irritable bowel syndrome (IBS)) and Celiac disease
- •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 within the preceding 3 weeks were excluded
- •Known allergy to probiotics
Outcomes
Primary Outcomes
Changes from baseline of anxiety subscale in Children's Behavior Checklist (CBCL)/Achenbach System of Empirically Based Assessment (ASEBA) at week 8 and week 16
Time Frame: Baseline, week 8 and week 16
ASEBA for behavioral assessment
Changes from hyperactivity subscale of Attention-Deficit/Hyperactivity Disorder Test (ADHDT) at week 8 and week 16
Time Frame: Baseline, week 8 and week 16
Inattention, hyperactive symptoms evaluation
Secondary Outcomes
- Change of total scores at week 8 and week 16 from baseline of Penn Interactive Peer Play Scale, (PIPPS)(Baseline, week 8 and week 16)
- Change of total scores at week 8 and week 16 from baseline of Social Interaction Assessment Scale(Baseline, week 8 and week 16)
- Gastrointestinal symptoms recorded by using GI Severity Index (6-GSI) at week 8 and week 16(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)(Baseline, week 8 and week 16)
- Comparison of Microbiota composition between week 8 and baseline(Baseline and week 8)