Microbiome and the Gut-Brain Axis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- The potential differences in gut microbiome profiles between persons diagnosed with a major mental illness vs. healthy controls.
研究概览
简要总结
This research study will examine the relationship interconnecting medical body health, mental health, and microbes of the digestive tract in persons living with serious mental illnesses,as compared to persons without such disorders. Existing research suggests that interactions between digestive tract microbes and the body may influence brain function circuits, mood, anxiety state, cognition, behavior, and medical physiology.
详细描述
People living with serious mental illnesses have far shorter life expectancy due to various attending medical disorders. Vast knowledge gaps exist regarding microbial taxa responsible for governing various the human states of health or morbidity or interactions with medications. Serious mental illnesses collectively comprise the single largest medical category of life-long disability worldwide. Mounting evidence in humans and in animal models of schizophrenia, post-traumatic stress disorder (PTSD) and related mental illnesses point to gut microbiome-host interactions that may influence brain function circuits, mood, anxiety state, cognition, behavior, as well as generate medical comorbidities. This research study will collect stool samples and blood for in vitro analysis of microbiome and metabolomics.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •People with an existing major mental illness, as already diagnosed currently or within the past year by their doctor prior to being consented,
- •Meeting criteria of the fourth or fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV or DSM 5) or ICD-9 or ICD-10;
- •Diagnosed with a cardiovascular disorder.
排除标准
- •Probiotic use currently or within 2 months prior to study enrollment,
- •Antibiotic treatment currently or within 2 months prior to study enrollment;
- •Diagnosis of an intellectual disability, pervasive developmental disorder, and/or progressive dementias including Alzheimer's disease.
结局指标
主要结局
The potential differences in gut microbiome profiles between persons diagnosed with a major mental illness vs. healthy controls.
时间窗: Baseline
In vitro metagenomic sequencing and taxa analyses of gut microbial DNA isolated from stool samples.
Correlation of blood biomarkers with gut microbiome taxa, comparing persons diagnosed with a major mental illness vs. healthy controls.
时间窗: Baseline
In vitro analysis of blood biomarkers including short chain fatty acids, inflammatory markers, and evidence for presence of bacteria.
次要结局
未报告次要终点