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

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ClinicalTrials.gov Identifier: NCT02849028
Recruitment Status : Unknown
Verified July 2016 by General Hospital of Ningxia Medical University.
Recruitment status was:  Recruiting
First Posted : July 29, 2016
Last Update Posted : July 29, 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 sleep disorder for TBI patients. The microbiota-gut-brain connection may further provide an opportunity for microbiota manipulation to treat the TBI patients with sleep disorders.This study is to investigate whether exist the relationship between sleep disorder and circadian rhythm of patients with TBI or not and focus the study on the potential of the host-microbiota interaction in regulating sleep disorder.

Condition or disease Intervention/treatment
Loss of Consciousness of Unspecified Duration Cerebral Laceration and Contusion Traumatic Brain Injury Behavioral: sleep disorder

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 disrupted sleep, which is especially common following mild TBI. And another one is intestinal function disorder.

Sleep 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 : 42 participants
Observational Model: Case Control
Official Title: The Clinical Research on the Relationship Between Circadian Rhythm and Gut Microbiota in TBI Patients
Study Start Date : July 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Disorders

Group/Cohort Intervention/treatment
TBI Patients with sleep disorder
All the patients should be diagnosed by polysomnographic (PSG)
Behavioral: sleep disorder
The study is to investigate whether exist the relationship between sleep disorder and circadian rhythm of patients with TBI or not.

health people
The people have a normal sleep
Behavioral: sleep disorder
The study is to investigate whether exist the relationship between sleep disorder and circadian rhythm of patients with TBI or not.




Primary Outcome Measures :
  1. the relationship between sleep disorder and circadian rhythm of patients with TBI [ Time Frame: From two weeks to three months after traumatic brain injury ]
    use real-time PCR and western blot to examine the mRNA and protein expression of circadian genes, BMAL1, Per2, Cry1, Melatonin, and compare with healthy control individuals.


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



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:   Yes
Sampling Method:   Probability Sample
Study Population
The number of patients is 21 and the health people is 21.
Criteria

Inclusion Criteria:

  • The mild TBI (mTBI) patients with sleep disorder (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)

Exclusion Criteria:

  • The mild TBI patients without sleep disorder and 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): NCT02849028


Contacts
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Contact: Xia Hechun, Bachelor 8613995199559 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 The General Hospital of Ningxia Medical University

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Responsible Party: General Hospital of Ningxia Medical University
ClinicalTrials.gov Identifier: NCT02849028     History of Changes
Other Study ID Numbers: xhechun1
First Posted: July 29, 2016    Key Record Dates
Last Update Posted: July 29, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by General Hospital of Ningxia Medical University:
gut microbiota
sleep disorder
gut-brain axis
circadian rhythm
Traumatic Brain Injury
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Unconsciousness
Lacerations
Contusions
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Wounds, Nonpenetrating
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms