Metabolic Abnormalities and Intestinal Microecology in Patients With Chronic Disorders of Consciousness

Sponsor

First Affiliated Hospital of Zhejiang University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04530968

Collaborator

(none)

200

Enrollment

Location

60.6

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Disorder of Consciousness	Other: No intervention

Detailed Description

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Metabolic Abnormalities and Intestinal Microecology in Patients With Chronic Disorders of Consciousness

Actual Study Start Date :

Mar 13, 2018

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Emerged from Minimally Conscious State (EMCS) Emerged from Minimally Conscious State (EMCS): recovery of functional object uses or communication from chronic	Other: No intervention No intervention
Minimally conscious state (MCS) Minimally conscious state (MCS): have reproducible signs of awareness and exhibit fluctuations in consciousness	Other: No intervention No intervention
Vegetative state (VS) Vegetative state (VS): can open their eyes and preserve sleep-wake cycles, but unaware of themselves and their surroundings	Other: No intervention No intervention
Healthy controls (HCs) Healthy controls (HCs)	Other: No intervention No intervention

Outcome Measures

Primary Outcome Measures

metabolic profiling and Intestinal microbial spectrum [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.

Secondary Outcome Measures

Coma Recovery Scale-Revised(CRS-R) [30 minutes before samples collection]
Coma Recovery Scale-Revised (CRS-R) score was used to quantify the severity, which consists of 23 hierarchically arranged items that comprise six subscales addressing auditory, visual, motor, oromotor/verbal, communication, and arousal processes. The lowest item on each subscale represents reflexive activity, whereas the highest items represent cognitively mediated behaviors In total, The lowest mark on the scale is 0 and the highest mark is 23. To a certain extent, the higher the score is, the better the level of consciousness is, whereas the lower the level of consciousness is.
Glasgow Outcome Scale (GOS) [6 months]
A GOS value of <3 was considered as a bad recovery, while a GOS value of ≥3 was considered as a good recovery.
Indicators of brain connectivity by EEG [On the same day as collecting the samples]
Phase locking value (PLV)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

Exclusion Criteria:

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