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Traumatic Brain Injury With Brief Loss of ConsciousnessNCT02874027

The Clinical Research on the Relationship Between Depression and Gut Microbiota in TBI Patients

An observational study of Traumatic Brain Injury With Brief Loss of Consciousness, run by General Hospital of Ningxia Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Microbiome studies may be highlighted as crucial in the development of depression for TBI patients. The microbiota-gut-brain connection may further provide an opportunity for microbiota manipulation to treat the TBI patients with depression.This study is to investigate whether exist the relationship between depression… Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
The TBI patients with depression
How many people
50 participants
Where
1 siteChina
Study dates
Aug 2016to May 2017
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: The number of patients is 25 and the health people is 25.

Who may be able to join

  • The mild TBI (mTBI) patients (a short loss of consciousness (<30 min), and/or a short post-traumatic amnesia (PTA) (< 24 h), a Glasgow Coma Scale (GCS) score between 13 and 15)
  • clinical diagnosis of depression

Who cannot join

  • the moderate and severe TBI patients.

Trial locations and contacts

1 site in 1 country.

Xia hechun, Bachelor contact

8613995109559

xhechun@aliyun.com

China1 site, 1 recruiting
  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, 750004

    Xia Hechun, Bachelor, 8613995109559, Xhechun@aliyun.com

    Recruiting

Other trials in China

About this study

Microbiome studies may be highlighted as crucial in the development of depression for TBI patients. The microbiota-gut-brain connection may further provide an opportunity for microbiota manipulation to treat the TBI patients with depression.This study is to investigate whether exist the relationship between depression and circadian rhythm of patients with TBI or not and focus the study on the potential of the host-microbiota interaction in regulating depression.

Read the detailed description

Neuroscientists are probing the connections between intestinal microbes and brain development. The general scaffolding of the brain-gut-enteric microbiota axis includes the central nervous system (CNS), the neuroendocrine and neuroimmune systems,the sympathetic and parasympathetic arms of the autonomic nervous system (ANS),the enteric nervous system (ENS), and of course the intestinal microbiota. These components interact to form a complex reflex network with afferent fibers that project to integrative CNS structures and efferent projections to the smooth muscle. Gut microbiota regulates intestinal and extraintestinal homeostasis. Accumulating evidence suggests that the gut microbiota may also regulate brain function and behavior. Results from animal models indicate that disturbances in the composition and functionality of some microbiota members are associated with neurophysiological disorders, strengthening the idea of a microbiota-gut-brain axis and the role of microbiota as a"peacekeeper" in the brain health. It is now clear that the gut-brain communication is bidirectional. On one hand, changes in the microbial community affect behavior. On the other hand, perturbations in behavior alter the composition of the gut microbiota. Since changes in the composition of the gut microbiota are associated with the behavioral and cognitive alterations, a healthy microbiota community is essential for a normal regulation of the microbiota-gut-brain axis. Among the potential factors regulating the axis, microbial metabolites may be the major mediators. Seven million traumatic brain injuries (TBIs) occur each year in the many countries. One of the most common sequelae in patients exposed to TBI is post-traumatic brain syndrome, which is especially common following mild TBI. And the common one is depression.Depression is governed by the intricate interplay between sleep wake homeostasis and circadian rhythms in the body. These rhythms are largely controlled by the suprachiasmatic nucleus (SCN) of the anterior hypothalamus. Clock genes form the molecular machinery of this circadian system, operating via autoregulatory feedback loops.

Among the vertebrate peripheral tissues that express circadian rhythms is the gastrointestinal system, which exhibit circadian rhythms in gene expression (including clock genes), motility and secretion in vivo and in vitro. These rhythms depend upon a patent molecular clock and they are also coordinated by SCN input via the sympathetic nervous system.

The emerging role of the gut microbiome as an important modulator of gastrointestinal function has recently included the role of circadian rhythms. Recent studies have suggested that microbial signaling plays a critical role in homeostatic maintenance of intestinal function along with the host circadian mechanism.

Being tested
The TBI patients with depression
Keywords
gut microbiota, depression, gut-brain axis, circadian rhythm, Traumatic Brain Injury
Medical subject headings
Depression, Brain Injuries, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The TBI patients with depressionOther

    The study is to investigate whether exist the relationship between depression and circadian rhythm of patients with TBI or not.

Study groups in NCT02874027
Study groupRoleWhat they receive
TBI Patients with depressionAll the patients should be diagnosed by CCMD-3(evaluation of depression)
Receives: Other: The TBI patients with depression
TBI Patients without depressionNot described
Receives: Other: The TBI patients with depression

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the relationship between depression and circadian rhythm of patients with TBI

    Measured: From three months to six months after traumatic brain injury

Secondary outcomes (1)
  1. the relationship between gut microbiota and circadian rhythm of patients with TBI

    Measured: From three months to six months after traumatic brain injury

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2016 (estimated)
  2. Study startAug 2016
  3. Primary completionMay 2017 (estimated)

Resources

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
Case-control
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02874027
Sponsor's protocol ID
xhechun2
Status last verified
Aug 2016
First submitted
17 Aug 2016
Last updated
23 Aug 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Traumatic Brain Injury With Brief Loss of Consciousness, run by General Hospital of Ningxia Medical 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 23 Aug 2016. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xia hechun, Bachelor (8613995109559, xhechun@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the relationship between depression and circadian rhythm of patients with TBI (time frame: From three months to six months after traumatic brain injury). 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 23 Aug 2016.

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