Metabolic Abnormalities and Intestinal Microecology in Patients With Chronic Disorders of Consciousness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- metabolic profiling and Intestinal microbial spectrum
研究概览
简要总结
Following severe traumatic brain injury, patients may remain unconscious for many years. It is the intestinal microbiome and metabolomics analysis comparing differentially intestinal microflora and metabolites between patients with chronic disorder of consciousness and controls so far. The investigators have mature data analysis technology. The obtained results provide new insight into understanding the molecular mechanisms underlying the chronic disorder of consciousness
详细描述
Objective
To determine differences in metabolic profiles and Intestinal microbial abundance among healthy human individuals and patients in a vegetative state (VS) and minimally conscious state (MCS) and to identify metabolites in human plasma that can accurately distinguish VS patients from MCS patients.
Method: Plasma samples and fecal sample were obtained from patients with chronic disorder of consciousness, and healthy volunteers. A comprehensive metabolic profile was obtained with targeted metabolomics analysis and untargeted and targeted lipidomics analysis, as well as intestinal microbial abundance from 16S rRNA gene amplicon sequencing.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients ages 18 to 80 years old;
- •Patients had a history of severe Traumatic brain injury (TBI);
- •Patients had awakened from a coma (indicating preserved sleep-wake cycles), including vegetative state and minimally consciousness state;
- •Patients stay unconscious for more than 1 month.
排除标准
- •Patients with disorders of consciousness caused by other inducements;
- •Other neurological or psychiatric conditions prior to the current brain injury;
- •Persistent seizure-like activity, inhibition or seizure inhibition;
- •The patients had taken a sedative barbiturate neuroleptics or antidepressants within one month;
- •The clinical state is unstable, and there are signs of spontaneous recovery or deterioration within 1 week;
- •The patients have taken gastrointestinal motility drugs or other drugs affecting gastrointestinal motility in the past month;
- •Had taken antibiotics and probiotics in the past month;
- •Patients with intestinal diseases such as colon cancer, ulcerative colitis or crohn's disease;
- •Patients with acute infectious diseases or liver dysfunction
结局指标
主要结局
metabolic profiling and Intestinal microbial spectrum
时间窗: 1 month
A comprehensive metabolic profile from plasma was obtained with targeted metabolomics analysis and untargeted and targeted lipidomics analysis; intestinal microbial spectrum was obetained from fecal by16S rRNA gene sequencing among HCs, EMCS, MCS and VS groups.
次要结局
- Glasgow Outcome Scale (GOS)(6 months)
- Coma Recovery Scale-Revised(CRS-R)(30 minutes before samples collection)
- Indicators of brain connectivity by EEG(On the same day as collecting the samples)