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

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02849028
• Other study ID #: xhechun1
• Status: Recruiting
• Phase: N/A
• First received: July 21, 2016
• Last updated: July 26, 2016
• Start date: July 2016
• Est. completion date: December 2016

Study information

• Verified date: July 2016
• Source: General Hospital of Ningxia Medical University
• Contact: Xia Hechun, Bachelor
• Phone: 8613995199559
• Email: Xhechun[@]aliyun.com
• Is FDA regulated: No
• Health authority: China: Ministry of Science and Technology
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Observational Model: Case Control

Related Conditions & MeSH terms

• Brain Injuries
• Cerebral Laceration and Contusion
• Contusions
• Lacerations
• Loss of Consciousness of Unspecified Duration
• Traumatic Brain Injury
• Unconsciousness

Intervention

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

Locations

Country	Name	City	State
China	General Hospital of Ningxia Medical University	Yinchuan	Ningxia

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Ningxia Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the relationship between sleep disorder and circadian rhythm of patients with TBI	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.	From two weeks to three months after traumatic brain injury	Yes
Secondary	the relationship between gut microbiota and circadian rhythm of patients with TBI	the relationship between gut microbiota and circadian rhythm of patients with TBI	From two weeks to three months after traumatic brain injury	Yes