Identifying Biomarkers of GI Comorbidities in ASD: A Longitudinal Pilot Study Linking Multi-Omics With Behavioral and Gastrointestinal Comorbidities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Gut Microbiome Alpha Diversity
研究概览
简要总结
This study investigates the microbiome-gut-brain axis in pediatric autism spectrum disorder (ASD). By longitudinally tracking participants, the study evaluates whether multi-omic profiles (gut microbiota and metabolome) correlate with behavioral and gastrointestinal fluctuations over time.
详细描述
Participants undergo longitudinal tracking over a 12-14 month period. Biological specimens (stool, blood, and urine) and clinical/behavioral metadata are collected at three-month intervals and during acute exacerbations of GI or behavioral symptoms to characterize multi-omic alterations.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 5-19 years old, male or female.
- •Confirmed ASD diagnosis using ADOS/ADOS-2 (or ADI-R).
排除标准
- •Past bowel surgery.
- •Serious chronic medical conditions (e.g., diabetes).
- •Use of anti-inflammatory medications.
- •History of inflammatory bowel disease, Celiac disease, H. pylori infection, or eosinophilic disorders.
- •Recent antibiotic use within 1 month prior to enrollment.
结局指标
主要结局
Gut Microbiome Alpha Diversity
时间窗: Baseline, 3, 6, 9, and 12-14 months
Evaluated via 16S rRNA and ITS gene sequencing from stool specimens to determine microbial diversity within a single sample. Unit of Measure: Shannon Diversity Index.
Gut Microbiome Relative Abundance
时间窗: Baseline, 3, 6, 9, and 12-14 months
Evaluated via 16S rRNA and ITS gene sequencing from stool specimens to identify changes in specific microbial taxa. Unit of Measure: Relative abundance, reported as the percentage (%) of total bacterial sequences.
Fecal Metabolomic Profile
时间窗: Baseline, 3, 6, 9, and 12-14 months
Characterization of stool specimens using mass spectrometry (LC-MS and GC-MS) to identify biochemical changes and microbial-produced metabolites. Unit of Measure: Relative concentration (or peak area abundance) of identified metabolites per gram of stool.
Blood Metabolomic Profile and Steroid Levels
时间窗: Baseline, 3, 6, 9, and 12-14 months
Characterization of blood specimens using mass spectrometry to evaluate metabolomics, specifically focusing on steroid levels. Unit of Measure: Relative concentration of identified metabolites and steroids in blood volume (e.g., ng/mL).
Urinary Metabolomic Profile
时间窗: Baseline, 3, 6, 9, and 12-14 months
Characterization of urine specimens using mass spectrometry to identify biochemical changes and microbial-produced metabolites. Unit of Measure: Relative concentration of identified metabolites in urine volume, normalized to creatinine.
次要结局
- Gastrointestinal Severity (GI Severity Index)(Baseline, 3, 6, 9, and 12-14 months)
- Functional Gastrointestinal Disorders Assessed by Rome IV(Baseline, 3, 6, 9, and 12-14 months)
- Gastrointestinal Signs and Symptoms Assessed by the GISSI-17(Baseline, 3, 6, 9, and 12-14 months)
- Behavioral Severity Assessed by the Aberrant Behavior Checklist (ABC)(Baseline, 3, 6, 9, and 12-14 months)
- Sensory Processing Assessed by the Child Sensory Profile 2(Baseline, 3, 6, 9, and 12-14 months)
- Repetitive Behaviors Assessed by the Repetitive Behavior Scale-Revised (RBS-R)(Baseline, 3, 6, 9, and 12-14 months)