Clinical trial NCT03982290: Psychophysiological Effects of Lactobacillus Plantarum PS128 in Preschool Children With Autism Spectrum Disorder
Official title: Psychophysiological Effects of Lactobacillus Plantarum PS128 in Preschool Children With Autism Spectrum Disorder: a Randomized, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autism
Keywords: autism
preschool children
Lead sponsor: Mackay Memorial Hospital
Sponsor class: OTHER
First posted: 2019-06-11
Enrollment: 250
Sex: ALL
Minimum age (years): 30
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Double-blinded, randomized, placebo-controlled
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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
timeFrame: Baseline, week 8 and week 16
measure: Changes from hyperactivity subscale of Attention-Deficit/Hyperactivity Disorder Test (ADHDT) at week 8 and week 16
timeFrame: Baseline, week 8 and week 16
Secondary outcomes:
measure: Gastrointestinal symptoms recorded by using GI Severity Index (6-GSI) at week 8 and week 16
timeFrame: Baseline, week 8 and week 16
measure: Change of total scores at week 8 and week 16 from baseline of Changes of Childhood Asperger Syndrome Test (CAST)
timeFrame: Baseline, week 8 and week 16
measure: Change of total scores at week 8 and week 16 from baseline of Penn Interactive Peer Play Scale, (PIPPS)
timeFrame: Baseline, week 8 and week 16
measure: Change of total scores at week 8 and week 16 from baseline of Social Interaction Assessment Scale
timeFrame: Baseline, week 8 and week 16
measure: Comparison of Microbiota composition between week 8 and baseline
timeFrame: Baseline and week 8
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Pediatric Neurology, MacKay Children's Hospital
Study officials:
affiliation: Department of Pediatric Neurology, MacKay Children's Hospital
name: Hui-Ju Chen MD
role: PRINCIPAL_INVESTIGATOR
References: