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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

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.

Detailed Summary:

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 gov
Sponsor: General Hospital of Ningxia Medical University

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: 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


Original Secondary Outcome: Same as current

Information By: General Hospital of Ningxia Medical University

Dates:
Date Received: July 21, 2016
Date Started: July 2016
Date Completion: December 2016
Last Updated: July 26, 2016
Last Verified: July 2016