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

NCT04530968 | Completed DMC

• 1 other identifier: microbiome and metabolomic
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Disorder of Consciousness

Keywords

Disorder of Consciousness; microbiome; metabolomics

Outcome Measures

Primary Outcomes (1)

• metabolic profiling and Intestinal microbial spectrum

  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.

  1 month

Secondary Outcomes (3)

• Coma Recovery Scale-Revised(CRS-R)

  30 minutes before samples collection

• Glasgow Outcome Scale (GOS)

  6 months

• Indicators of brain connectivity by EEG

  On the same day as collecting the samples

Study Arms (4)

Emerged from Minimally Conscious State (EMCS)

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

Other: No intervention

Minimally conscious state (MCS)

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

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

Other: No intervention

Healthy controls (HCs)

Healthy controls (HCs)

Other: No intervention

Interventions

No intervention OTHER

No intervention

Emerged from Minimally Conscious State (EMCS); Healthy controls (HCs); Minimally conscious state (MCS); Vegetative state (VS)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

SCIEX QTRAP 5500 liquid chromatograph / triple quadrupole mass spectrometer.

Hangzhou, Zhejiang, 310002, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma for metabolites and lipids；Fecal samples for microbiome and metabolites.

MeSH Terms

Conditions

Consciousness Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 28, 2020
• Study Start: March 13, 2018
• Primary Completion: September 1, 2022
• Study Completion: April 1, 2023
• Last Updated: May 7, 2024

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)