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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04530968
Enrollment
200
Registered
2020-08-28
Start date
2018-03-13
Completion date
2023-04-01
Last updated
2024-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disorder of Consciousness

Keywords

Disorder of Consciousness, microbiome, metabolomics

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

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.

Interventions

OTHERNo intervention

No intervention

Sponsors

First Affiliated Hospital of Zhejiang University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
metabolic profiling and Intestinal microbial spectrum1 monthA 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

MeasureTime frameDescription
Coma Recovery Scale-Revised(CRS-R)30 minutes before samples collectionComa 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 monthsA 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 EEGOn the same day as collecting the samplesPhase locking value (PLV)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026