Disorder of ConsciousnessNCT04530968
Metabolic Abnormalities and Intestinal Microecology in Patients With Chronic Disorders of Consciousness
An observational study of Disorder of Consciousness, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Disorder of Consciousness
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 13 Mar 2018to 1 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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 locations and contacts
1 site in 1 country.
China1 site
SCIEX QTRAP 5500 liquid chromatograph / triple quadrupole mass spectrometer.
Hangzhou, Zhejiang, 310002
About this study
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
Read the 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.
- Conditions
- Disorder of Consciousness
- Being tested
- No intervention
- Keywords
- Disorder of Consciousness, microbiome, metabolomics
- Medical subject headings
- Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Emerged from Minimally Conscious State (EMCS) | Emerged from Minimally Conscious State (EMCS): recovery of functional object uses or communication from chronic Receives: Other: No intervention | |
| Minimally conscious state (MCS) | Minimally conscious state (MCS): have reproducible signs of awareness and exhibit fluctuations in consciousness Receives: 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 Receives: Other: No intervention | |
| Healthy controls (HCs) | Healthy controls (HCs) Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (3)
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.
Measured: 30 minutes before samples collection
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.
Measured: 6 months
Indicators of brain connectivity by EEG
Phase locking value (PLV)
Measured: On the same day as collecting the samples
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start13 Mar 2018
- Primary completion1 Sep 2022
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorder of ConsciousnessStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04530968
- Sponsor's protocol ID
- microbiome and metabolomic
- Status last verified
- Jul 2020
- First submitted
- 29 Jul 2020
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Abnormalities and Intestinal Microecology in Patients With Chronic Disorders of Consciousness
- ClinicalTrials.gov ID
- NCT04530968
- Acronym / sponsor ID
- microbiome and metabolomic
- Conditions
- Disorder of Consciousness
- Keywords
- Disorder of Consciousness, microbiome, metabolomics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 13 Mar 2018 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 28 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Emerged from Minimally Conscious State (EMCS) | – | Other: No interventionEmerged from Minimally Conscious State (EMCS): recovery of functional object uses or communication from chronic |
| Minimally conscious state (MCS) | – | Other: No interventionMinimally conscious state (MCS): have reproducible signs of awareness and exhibit fluctuations in consciousness |
| Vegetative state (VS) | – | Other: No interventionVegetative state (VS): can open their eyes and preserve sleep-wake cycles, but unaware of themselves and their surroundings |
| Healthy controls (HCs) | – | Other: No interventionHealthy controls (HCs) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Emerged from Minimally Conscious State (EMCS), Healthy controls (HCs), Minimally conscious state (MCS), Vegetative state (VS) |
Primary outcome
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.
3 secondary outcomes
Coma Recovery Scale-Revised(CRS-R)
Time frame: 30 minutes before samples collection
Glasgow Outcome Scale (GOS)
Time frame: 6 months
Indicators of brain connectivity by EEG
Time frame: On the same day as collecting the samples
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disorder of Consciousness, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
metabolic profiling and Intestinal microbial spectrum (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024; AzTrials last refreshed its copy on 6 Nov 2026.