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

Zhejiang University logo

Zhejiang University

Status

Unknown

Conditions

Disorder of Consciousness

Treatments

Other: No intervention

Study type

Observational

Funder types

Other

Identifiers

NCT04530968
microbiome and metabolomic

Details and patient eligibility

About

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

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

200 participants in 4 patient groups

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

Trial contacts and locations

0

Loading...

Central trial contact

Benyan Luo, PhD; Fangping He, MS

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems