Effects of Lactobacillus Plantarum PS128 in Children With Autism Spectrum Disorder

Chang Gung Memorial Hospital1 site in 1 country120 target enrollmentJuly 15, 2022

ConditionsAutism Spectrum Disorder

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Autism Spectrum Disorder
Sponsor: Chang Gung Memorial Hospital
Enrollment: 120
Locations: 1
Primary Endpoint: Changes of total scores of Social Responsiveness Scale
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Autism spectrum disorder (ASD) is a neurodevelopmental disorder that can cause significant social, communication and behavioral deficits. Probiotics are regarded as active microorganisms. With sufficient amounts, probiotics can regulate intestinal flora, intestinal permeability, inflammation and antioxidant reactions in the body. These reactions may further promote health, regulate metabolic disease progression and prevent complications. Lactobacillus plantarum PS128 (PS128) was reported to be a psychobiotic in several animal and human studies which modulated the levels of neurotransmitters in different brain areas. This study is to evaluate whether the consumption of PS128 can improve the symptoms of patients with ASD. The current randomized, placebo-controlled trial was conducted to investigate the psychophysiological effects of PS128 in school children with ASD.

Registry

clinicaltrials.gov

Start Date

July 15, 2022

End Date

December 31, 2026

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Chang Gung Memorial Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•(1) Age 7 to 12 years old.
•(2) PS128 group and placebo group: Children with autism spectrum disorder, confirmed by Autism Diagnostic Observation Schedule.
•(3) Normal control group: Children without autism spectrum disorder.

Exclusion Criteria

•(1) Receiving antibiotics within one month.
•(2) Probiotics used in powder, capsule, or tablet in two weeks (except for Yogurt, Yogurt, Yakult and other related foods).
•(3) Patients with hepatobiliary gastrointestinal tract who have undergone surgery (except for hernia surgery and appendectomy)
•(4) Those with special diets (gluten-free, casein-free, high-protein, and ketogenic diet).
•(5) Those with a history of cancer.
•(6) Those who are allergic to lactic acid bacteria.
•(7) Not eligible judged by PI

Outcomes

Primary Outcomes

Changes of total scores of Social Responsiveness Scale

Time Frame: Baseline, Week 12 and Week 16

Social Responsiveness Scale can measure the autism clinical severity with the range from 65-260. The lower scores stand for better social responsiveness.

Secondary Outcomes

Changes of total scores of Child Behavior Checklist(Baseline, Week 12 and Week 16)
Changes of total scores of Adaptive Behavior Assessment System(Baseline, week 12 and Week 16W)
Changes in accuracy of Eyes task(Baseline, Week 12 and Week 16)
Changes of total scores of Aberrant Behavior Checklist(Baseline, Week 12 and Week 16)
Safety assessment - Uric Acid(Baseline and Week 12)
Change in levels of exploratory blood-based biomarkers for inflammatory changes - IL-1β(Baseline and Week 12)
Changes in accuracy of Frith-Happe animation(Baseline, Week 12 and Week 16)
Changes of total scores of Parenting Stress Index, Fourth Editon(Baseline, Week 12 and Week 16)
Assessment of Clinical Global Impression-Severity of Illness(Baseline, Week 12 and Week 16)
Diffusion Tensor Imaging (DTI) - FA(Baseline and Week 12)
Safety assessment - Total Protein(Baseline and Week 12)
Safety assessment - ALP(Baseline and Week 12)
Changes of total scores of Repetitive Behavior Scale-Revised(Baseline, Week 12 and Week 16)
Gut microbiota(Baseline and Week 12)
Safety assessment - Creatinine(Baseline and Week 12)
Safety assessment - AST(Baseline and Week 12)
Change in levels of exploratory blood-based biomarkers for inflammatory changes - Eotaxin(Baseline and Week 12)
Change in levels of exploratory blood-based biomarkers for inflammatory changes - IL-6(Baseline and Week 12)
Change in levels of exploratory blood-based biomarkers for oxidative stress changes - GABA(Baseline and Week 12)
Visual Analogue Scale for GI symptoms(Baseline, week 12 and Week 16)
MRI T1(Baseline and Week 12)
functional MRI (resting-state/biological motion task) - BOLD signal(Baseline and Week 12)
Safety assessment - Total Bilirubin(Baseline and Week 12)
Changes of total scores of Emotional Dysregulation Inventory(Baseline, Week 12 and Week 16)
Assessment of Patient Global Impression of Change(Week 12 and Week 16)
Safety assessment - Albumin(Baseline and Week 12)
Safety assessment - T-Cholesterol(Baseline and Week 12)
Safety assessment - BUN(Baseline and Week 12)
Safety assessment - ALT(Baseline and Week 12)
Change in levels of exploratory blood-based biomarkers for inflammatory changes - MPO(Baseline and Week 12)
Change in levels of exploratory blood-based biomarkers for inflammatory changes - TGF-β1(Baseline and Week 12)
Change in levels of exploratory blood-based biomarkers for oxidative stress changes - Serotonin(Baseline and Week 12)
Change in levels of exploratory blood-based biomarkers for oxidative stress changes - Cortisol(Baseline and Week 12)