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

Autism Clinical Trial

Official title:

Psychophysiological Effects of Lactobacillus Plantarum PS128 in Preschool Children With Autism Spectrum Disorder: a Randomized, Placebo-controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03982290
• Other study ID #: 17MMHIS193e
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: December 2020

Study information

• Verified date: June 2019
• Source: Mackay Memorial Hospital
• Contact: Hui-Ju Chen MD
• Phone: 02-25433535
• Email: hjuchen0623[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Months to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism
• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Other:
• Probiotic, Lactobacillus plantarum PS128
PS128 capsules, 2 capsules per day
• Placebo, microcrystalline cellulose
Placebo capsules, 2 capsules per day

Locations

Country	Name	City	State
Taiwan	Department of Pediatric Neurology, MacKay Children's Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Mackay Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	ASEBA for behavioral assessment	Baseline, week 8 and week 16
Primary	Changes from hyperactivity subscale of Attention-Deficit/Hyperactivity Disorder Test (ADHDT) at week 8 and week 16	Inattention, hyperactive symptoms evaluation	Baseline, week 8 and week 16
Secondary	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	Baseline, week 8 and week 16
Secondary	Change of total scores at week 8 and week 16 from baseline of Changes of Childhood Asperger Syndrome Test (CAST)	CAST for behavioral assessment	Baseline, week 8 and week 16
Secondary	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	Baseline, week 8 and week 16
Secondary	Change of total scores at week 8 and week 16 from baseline of Social Interaction Assessment Scale	Communicative and interactive assessment	Baseline, week 8 and week 16
Secondary	Comparison of Microbiota composition between week 8 and baseline	Gut and oral microbiota analysis	Baseline and week 8