- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02874027
The Clinical Research on the Relationship Between Depression and Gut Microbiota in TBI Patients
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Ningxia
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Yinchuan, Ningxia, China, 750004
- Recruiting
- General Hospital of Ningxia Medical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
the moderate and severe TBI patients.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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TBI Patients with depression
All the patients should be diagnosed by CCMD-3(evaluation of depression)
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The study is to investigate whether exist the relationship between depression and circadian rhythm of patients with TBI or not.
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TBI Patients without depression
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The study is to investigate whether exist the relationship between depression and circadian rhythm of patients with TBI or not.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the relationship between depression and circadian rhythm of patients with TBI
Time Frame: From three months to six months after traumatic brain injury
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From three months to six months after traumatic brain injury
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the relationship between gut microbiota and circadian rhythm of patients with TBI
Time Frame: From three months to six months after traumatic brain injury
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From three months to six months after traumatic brain injury
|
Collaborators and Investigators
Investigators
- Study Director: Xia Hechun, Bachelor, General Hospital of Ningxia Medical University
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Wounds and Injuries
- Neurobehavioral Manifestations
- Craniocerebral Trauma
- Trauma, Nervous System
- Consciousness Disorders
- Depression
- Brain Injuries
- Brain Injuries, Traumatic
- Unconsciousness
Other Study ID Numbers
- xhechun2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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