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

May 6, 2024 updated by: First Affiliated Hospital of Zhejiang University
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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310002
        • SCIEX QTRAP 5500 liquid chromatograph / triple quadrupole mass spectrometer.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Emerged from Minimally Conscious State (EMCS)
Emerged from Minimally Conscious State (EMCS): recovery of functional object uses or communication from chronic
Other: No intervention
No intervention
Minimally conscious state (MCS)
Minimally conscious state (MCS): have reproducible signs of awareness and exhibit fluctuations in consciousness
Other: No intervention
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
No intervention
Healthy controls (HCs)
Other: No intervention
No intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
metabolic profiling and Intestinal microbial spectrum
Time Frame: 1 month
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Coma Recovery Scale-Revised(CRS-R)
Time Frame: 30 minutes before samples collection
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
Glasgow Outcome Scale (GOS)
Time Frame: 6 months
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
Indicators of brain connectivity by EEG
Time Frame: On the same day as collecting the samples
Phase locking value (PLV)
On the same day as collecting the samples

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
First Affiliated Hospital of Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 13, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 29, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • microbiome and metabolomic

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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