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

Disorder of Consciousness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04530968
• Other study ID #: microbiome and metabolomic
• Status: Recruiting
• Start date: March 13, 2018
• Est. completion date: April 1, 2023

Study information

• Verified date: July 2020
• Source: First Affiliated Hospital of Zhejiang University
• Contact: Benyan Luo, PhD
• Phone: 13967166677
• Email: luobenyan[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 1, 2023
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Consciousness Disorders
• Disease
• Disorder of Consciousness

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
China	SCIEX QTRAP 5500 liquid chromatograph / triple quadrupole mass spectrometer.	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Coma Recovery Scale-Revised(CRS-R)	Coma 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.	30 minutes before samples collection
Secondary	Glasgow Outcome Scale (GOS)	A GOS value of <3 was considered as a bad recovery, while a GOS value of =3 was considered as a good recovery.	6 months
Secondary	Indicators of brain connectivity by EEG	Phase locking value (PLV)	On the same day as collecting the samples