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

Not Applicable

• Conditions: Autism
• Interventions: Other: Probiotic, Lactobacillus plantarum PS128; Other: Placebo, microcrystalline cellulose

• Registration Number: NCT03982290
• Lead Sponsor: Mackay Memorial Hospital

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.

Study Timeline

• Study Start: 2018-10-01
• Study First Submitted: 2019-05-31
• Status Verified: 2019-06
• Study First Submitted QC: 2019-06-10
• Last Update Submitted: 2019-06-10
• Study First Posted: 2019-06-11
• Last Update Posted: 2019-06-11
• Primary Completion: 2019-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lactobacillus plantarum PS128 (PS128)	Probiotic, Lactobacillus plantarum PS128	Subjects will receive oral Lactobacillus plantarum PS128 capsules, 2 capsules per day, for 16 weeks.
Placebo	Placebo, microcrystalline cellulose	Subjects will receive oral placebo capsules, 2 capsules per day, for the first 8 weeks. The following 8 weeks, subjects will receive oral Lactobacillus plantarum PS128 capsules, 2 capsules per day, for 8 weeks.

Primary Outcome Measures

Name	Time	Method
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	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	Baseline, week 8 and week 16	Inattention, hyperactive symptoms evaluation

Secondary Outcome Measures

Name	Time	Method
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	PIPPS for communicative and interactive assessment
Change of total scores at week 8 and week 16 from baseline of Social Interaction Assessment Scale	Baseline, week 8 and week 16	Communicative and interactive assessment
Gastrointestinal symptoms recorded by using GI Severity Index (6-GSI) at week 8 and week 16	Baseline, week 8 and week 16	constipation, diarrhea, stool consistency, stool smell, flatulence, and abdominal pain
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	CAST for behavioral assessment
Comparison of Microbiota composition between week 8 and baseline	Baseline and week 8	Gut and oral microbiota analysis

Trial Locations

Locations (1)

Department of Pediatric Neurology, MacKay Children's Hospital; 🇨🇳 Taipei, Taiwan