NCT05307744终止不适用
Effects of Lactobacillus Plantarum PS128 in Children With Autism Spectrum Disorder
Chang Gung Memorial Hospital2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2022年7月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Changes of total scores of Social Responsiveness Scale
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(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.
排除标准
- •(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
结局指标
主要结局
Changes of total scores of Social Responsiveness Scale
时间窗: 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.
Changes of Total Scores of Social Responsiveness Scale
时间窗: 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.
次要结局
- 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)
- 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)
- 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)
- 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)
- Safety Assessment - T-Cholesterol(Baseline and Week 12)
- Assessment of Patient Global Impression of Change(Week 12 and Week 16)
- MRI T1(Baseline and Week 12)
- Diffusion Tensor Imaging (DTI) - FA(Baseline and Week 12)
- Changes of Total Scores of Repetitive Behavior Scale-Revised(Baseline, Week 12 and Week 16)
- 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 16)
- Changes in Accuracy of Frith-Happe Animation(Baseline, Week 12 and Week 16)
- 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)
- Changes of Total Scores of Emotional Dysregulation Inventory(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(Week 12 and Week 16)
- Gut Microbiota-Relative Abundance of Bifidobacterium Faecale(Baseline and Week 12)
- Safety Assessment - Uric Acid(Baseline and Week 12)
- Functional MRI (Resting-state/Biological Motion Task) - BOLD Signal(Baseline and Week 12)
- Safety Assessment - Albumin(Baseline and Week 12)
- Safety Assessment - Total Protein(Baseline and Week 12)
- Safety Assessment - ALP(Baseline and Week 12)
- Safety Assessment - Total Bilirubin(Baseline and Week 12)
- Safety Assessment - BUN(Baseline and Week 12)
- Safety Assessment - Creatinine(Baseline and Week 12)
- Safety Assessment - AST(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 - IL-1β(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 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 - Serotonin(Baseline and Week 12)
- Change in Levels of Exploratory Blood-based Biomarkers for Oxidative Stress Changes - GABA(Baseline and Week 12)
- Change in Levels of Exploratory Blood-based Biomarkers for Oxidative Stress Changes - Cortisol(Baseline and Week 12)
- Gut Microbiota-Relative Abundance of Lactiplantibacillus Plantarum(Baseline and Week 12)
研究者
研究点 (2)
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