Clinical trial NCT05307744: Effects of Lactobacillus Plantarum PS128 in Children With ASD
Official title: Effects of Lactobacillus Plantarum PS128 in Children With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Bened Biomedical Co., Ltd.
First posted: 2022-04-01
Enrollment: 120
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

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