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

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ClinicalTrials.gov Identifier: NCT02874027
Recruitment Status : Unknown
Verified August 2016 by General Hospital of Ningxia Medical University.
Recruitment status was:  Recruiting
First Posted : August 22, 2016
Last Update Posted : August 23, 2016
Sponsor:
Information provided by (Responsible Party):
General Hospital of Ningxia Medical University

Brief 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 and circadian rhythm of patients with TBI or not and focus the study on the potential of the host-microbiota interaction in regulating depression.

Condition or disease Intervention/treatment
Traumatic Brain Injury With Brief Loss of Consciousness Other: The TBI patients with depression

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.


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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case Control
Official Title: The Clinical Research on the Relationship Between Depression and Gut Microbiota in TBI Patients
Study Start Date : August 2016
Estimated Primary Completion Date : May 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
TBI Patients with depression
All the patients should be diagnosed by CCMD-3(evaluation of depression)
Other: The TBI patients with depression
The study is to investigate whether exist the relationship between depression and circadian rhythm of patients with TBI or not.

TBI Patients without depression Other: The TBI patients with depression
The study is to investigate whether exist the relationship between depression and circadian rhythm of patients with TBI or not.




Primary Outcome Measures :
  1. the relationship between depression and circadian rhythm of patients with TBI [ Time Frame: From three months to six months after traumatic brain injury ]

Secondary Outcome Measures :
  1. the relationship between gut microbiota and circadian rhythm of patients with TBI [ Time Frame: From three months to six months after traumatic brain injury ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The number of patients is 25 and the health people is 25.
Criteria

Inclusion Criteria:

  1. 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)
  2. clinical diagnosis of depression

Exclusion Criteria:

the moderate and severe TBI patients.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02874027


Contacts
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Contact: Xia hechun, Bachelor 8613995109559 xhechun@aliyun.com

Locations
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China, Ningxia
General Hospital of Ningxia Medical University Recruiting
Yinchuan, Ningxia, China, 750004
Contact: Xia Hechun, Bachelor    8613995109559    Xhechun@aliyun.com   
Sponsors and Collaborators
General Hospital of Ningxia Medical University
Investigators
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Study Director: Xia Hechun, Bachelor General Hospital of Ningxia Medical University

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Responsible Party: General Hospital of Ningxia Medical University
ClinicalTrials.gov Identifier: NCT02874027     History of Changes
Other Study ID Numbers: xhechun2
First Posted: August 22, 2016    Key Record Dates
Last Update Posted: August 23, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by General Hospital of Ningxia Medical University:
gut microbiota
depression
gut-brain axis
circadian rhythm
Traumatic Brain Injury

Additional relevant MeSH terms:
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Depression
Brain Injuries
Brain Injuries, Traumatic
Unconsciousness
Behavioral Symptoms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms