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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-13

Study Completion Date

2023-04-01

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Disorder of Consciousness

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Emerged from Minimally Conscious State (EMCS)

Emerged from Minimally Conscious State (EMCS): recovery of functional object uses or communication from chronic

No intervention

Intervention Type OTHER

No intervention

Minimally conscious state (MCS)

Minimally conscious state (MCS): have reproducible signs of awareness and exhibit fluctuations in consciousness

No intervention

Intervention Type OTHER

No intervention

Vegetative state (VS)

Vegetative state (VS): can open their eyes and preserve sleep-wake cycles, but unaware of themselves and their surroundings

No intervention

Intervention Type OTHER

No intervention

Healthy controls (HCs)

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Patients ages 18 to 80 years old;
2. Patients had a history of severe Traumatic brain injury (TBI);
3. Patients had awakened from a coma (indicating preserved sleep-wake cycles), including vegetative state and minimally consciousness state;
4. Patients stay unconscious for more than 1 month.

Exclusion Criteria

1. Patients with disorders of consciousness caused by other inducements;
2. Other neurological or psychiatric conditions prior to the current brain injury;
3. Persistent seizure-like activity, inhibition or seizure inhibition;
4. The patients had taken a sedative barbiturate neuroleptics or antidepressants within one month;
5. The clinical state is unstable, and there are signs of spontaneous recovery or deterioration within 1 week;
6. The patients have taken gastrointestinal motility drugs or other drugs affecting gastrointestinal motility in the past month;
7. Had taken antibiotics and probiotics in the past month;
8. Patients with intestinal diseases such as colon cancer, ulcerative colitis or crohn's disease;
9. Patients with acute infectious diseases or liver dysfunction

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes