植物乳杆菌 PS128 对自闭症儿童的影响

实验性的：PS128

受试者每天服用 PS128 胶囊（每天 2 粒，一次），持续 12 周。

膳食补充剂：PS128

每个 PS128 胶囊含有 >3 × 10^10 个菌落形成单位 (CFU) 和微晶纤维素，重量为 425 ± 25 mg。

安慰剂比较：安慰剂

受试者将每天服用安慰剂胶囊（每天 2 粒胶囊，一次），持续 12 周。

其他：安慰剂

安慰剂胶囊仅含有 425 ± 25 mg 微晶纤维素。

无干预：正常控制

正常对照组是由年龄、性别相匹配的健康儿童邀请入组。

Changes of Total Scores of Social Responsiveness Scale

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 Repetitive Behavior Scale-Revised

Repetitive Behavior Scale-Revised is a questionnaire that focuses on repetitive behavior. The score ranges from 0-129. The lower scores stand for lower repetitive behavior.

Changes of Total Scores of Child Behavior Checklist

Child Behavior Checklist is a parents' report questionnaire for behavioral and emotional problems. The score ranges from 0-240. The lower scores stand for better behavioral and emotional regulation.

Changes of Total Scores of Adaptive Behavior Assessment System

Adaptive Behavior Assessment System is a parents' report questionnaire for adaptive behavior. The score ranges from 9-171. The higher scores stand for better adaptive behavior.

Changes in Accuracy of Frith-Happe Animation

A quick and objective test of Theory of Mind. 8 questions in total, the more correct questions stand for better Social Cognition.

Changes in Accuracy of Eyes Task

An advanced test for Theory of Mind. 43 questions in total, the more correct questions stand for better social skills.

Changes of Total Scores of Aberrant Behavior Checklist

Aberrant Behavior Checklist is a parents' report questionnaire for aberrant behavior. The score ranges from 0-174. The lower scores stand for less aberrant behavior.

Changes of Total Scores of Emotional Dysregulation Inventory

Emotional Dysregulation Inventory is a parents' report questionnaire for emotional dysregulation. The score ranges from 0-120. The lower scores stand for better emotional regulation.

Changes of Total Scores of Parenting Stress Index, Fourth Editon

Parenting Stress Index is a parents' report questionnaire for parenting stress. The score ranges from 0-180. The lower scores stand for lower parenting stress.

Assessment of Clinical Global Impression-Severity of Illness

The Clinical Global Impression (CGI) is a clinician rated measure of illness severity, improvement, and efficacy of treatment. The CGI-I is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. The score ranges from 1-7. CGI Improvement scale: 1=very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; 7=Very much worse.

Assessment of Patient Global Impression of Change

The self-report measure Patient Global Impression of Change (PGIC) reflects a patient's belief about the efficacy of treatment. PGIC is a 7 point scale depicting a patient's rating of overall improvement. The score ranges from 1-7. Patients rate their change as "1=very much improved ," "2=much improved," "3=minimally improved," "4=no change," "5=minimally worse," "6=much worse," or "7=very much worse)."

Gut Microbiota-Relative Abundance of Bifidobacterium Faecale

Collect the DNA of fecal flora to test the diversity and abundance of gut microbiota as well as short chain fatty acids in Stool samples. The 16S rRNA gene amplicons will be prepared following the Illumina protocol for preparing the 16S metagenomic sequencing library. Values represent percentages and range from 0 to 100%, with higher values indicating a higher relative abundance of the target bacterium in the gut microbiota

MRI T1

Brain structural volumes (cm²). The advanced processing and analysis of the MRI data have been outsourced to an external core facility. Due to resource scheduling and the prolonged timeline required for specialized image preprocessing, the data analysis is currently in progress and has not yet been finalized. Therefore, quantifiable results are unavailable for summary in the data table at this time.

Functional MRI (Resting-state/Biological Motion Task) - BOLD Signal

Blood-oxygen-level-dependent (BOLD) signal is a measurement used in fMRI, which reflects the neural activity. The advanced processing and analysis of the MRI data have been outsourced to an external core facility. Due to resource scheduling and the prolonged timeline required for specialized image preprocessing, the data analysis is currently in progress and has not yet been finalized. Therefore, quantifiable results are unavailable for summary in the data table at this time.

Diffusion Tensor Imaging (DTI) - FA

Fractional anisotropy (FA) is a measurement used in DTI, which reflects the movement of water molecules. FA ranges from 0 to 1, the higher FA value may represent more intact axons. The advanced processing and analysis of the MRI data have been outsourced to an external core facility. Due to resource scheduling and the prolonged timeline required for specialized image preprocessing, the data analysis is currently in progress and has not yet been finalized. Therefore, quantifiable results are unavailable for summary in the data table at this time.

Safety Assessment - Albumin

Safety is assessed function of liver and kidney such as albumin (3.5-5.4 g/dl).

Safety Assessment - Total Protein

Safety is assessed function of liver and kidney such as total protein (6.4-8.3 g/dl).

Safety Assessment - ALP

Safety is assessed function of liver and kidney such as ALP (135-320 U/L).

Safety Assessment - Total Bilirubin

Safety is assessed function of liver and kidney such as total bilirubin (0.3-1.2 mg/dl).

Safety Assessment - T-Cholesterol

Safety is assessed function of liver and kidney such as T-Cholesterol (<170 mg/dL).

Safety Assessment - Uric Acid

Safety is assessed function of liver and kidney such as uric acid (<7.0 mg/dl).

Safety Assessment - BUN

Safety is assessed function of liver and kidney such as BUN (7-25 mg/dl).

Safety Assessment - Creatinine

Safety is assessed function of liver and kidney such as creatinine (0.2-1.0 mg/dl).

Safety Assessment - AST

Safety is assessed function of liver and kidney such as AST (13-40 U/L).

Safety Assessment - ALT

Safety is assessed function of liver and kidney such as ALT (7-40 U/L).

Change in Levels of Exploratory Blood-based Biomarkers for Inflammatory Changes - MPO

Inflammatory is assessed via a composite measure of circulating cytokines - MPO (ng/mL)

Change in Levels of Exploratory Blood-based Biomarkers for Inflammatory Changes - IL-1β

Inflammatory is assessed via a composite measure of circulating cytokines - IL-1β (pg/mL)

Change in Levels of Exploratory Blood-based Biomarkers for Inflammatory Changes - TGF-β1

Inflammatory is assessed via a composite measure of circulating cytokines - TGF-β1 (pg/mL)

Change in Levels of Exploratory Blood-based Biomarkers for Inflammatory Changes - Eotaxin

Inflammatory is assessed via a composite measure of circulating cytokines - Eotaxin (pg/mL)

Change in Levels of Exploratory Blood-based Biomarkers for Inflammatory Changes - IL-6

Inflammatory is assessed via a composite measure of circulating cytokines - IL-6 (ng/mL)

Change in Levels of Exploratory Blood-based Biomarkers for Oxidative Stress Changes - Serotonin

Oxidative stress is assessed via Serotonin (ng/mL).

Change in Levels of Exploratory Blood-based Biomarkers for Oxidative Stress Changes - GABA

Oxidative stress is assessed via GABA (μmol/L).

Change in Levels of Exploratory Blood-based Biomarkers for Oxidative Stress Changes - Cortisol

Oxidative stress is assessed via Cortisol (6-10am 4.82-19.5, 4-8pm 2.47-11.9, μg/dl).

Gut Microbiota-Relative Abundance of Lactiplantibacillus Plantarum

Collect the DNA of fecal flora to test the diversity and abundance of gut microbiota as well as short chain fatty acids in Stool samples. The 16S rRNA gene amplicons will be prepared following the Illumina protocol for preparing the 16S metagenomic sequencing library. Values represent percentages and range from 0 to 100%, with higher values indicating a higher relative abundance of the target bacterium in the gut microbiota.