Clinical trial NCT04530968: Metabolic Abnormalities and Intestinal Microecology in Patients With Chronic Disorders of Consciousness
Official title: Metabolic Abnormalities and Intestinal Microecology in Patients With Chronic Disorders of Consciousness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Disorder of Consciousness
Keywords: Disorder of Consciousness
microbiome
metabolomics
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2020-08-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic disorder of consciousness were recruited at the rehabilitation units of Hangzhou Hospital of Zhejiang Armed Police Corps, China and Hangzhou Mingzhou Brain Rehabilitation Hospital.

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.

Eligibility criteria: 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

Primary outcomes:
measure: metabolic profiling and Intestinal microbial spectrum
timeFrame: 1 month
Secondary outcomes:
measure: Coma Recovery Scale-Revised(CRS-R)
timeFrame: 30 minutes before samples collection
measure: Glasgow Outcome Scale (GOS)
timeFrame: 6 months
measure: Indicators of brain connectivity by EEG
timeFrame: On the same day as collecting the samples
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: SCIEX QTRAP 5500 liquid chromatograph / triple quadrupole mass spectrometer.
state: Zhejiang
Study officials:
References: