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Status unknownNCT02849028Updated Jul 29, 2016

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

An observational study in Loss of Consciousness of Unspecified Duration, Cerebral Laceration and Contusion and Traumatic Brain Injury, sponsored by General Hospital of Ningxia Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-07-29.

Sponsored by General Hospital of Ningxia Medical University · Observational

The sponsor has not verified this record recently (last verified Jul 2016), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Enrollment
42
Ages
18 Years to 60 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Loss of Consciousness of Unspecified Duration
  • Cerebral Laceration and Contusion
  • Traumatic Brain Injury

Keywords

  • gut microbiota
  • sleep disorder
  • gut-brain axis
  • circadian rhythm
  • Traumatic Brain Injury
03

In context

Contusions

43 studies on the registry are indexed under Contusions; 8 are open to participants now.

This study's planned enrollment of 42 is below the median of 75 across 10 observational studies indexed under Contusions.

Browse Contusions studies →

Lead sponsor

General Hospital of Ningxia Medical University is the lead sponsor of 110 studies on the registry; 43 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

The number of patients is 21 and the health people is 21.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • The mild TBI patients without sleep disorder and the moderate and severe TBI patients.
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Study design

Observational model
Case-control
Enrollment
42 participants (estimated)
Patient registry
No

Groups and cohorts

  • TBI Patients with sleep disorder

    All the patients should be diagnosed by polysomnographic (PSG)

    Behavioral: sleep disorder

  • health people

    The people have a normal sleep

    Behavioral: sleep disorder

Interventions

  • Behavioralsleep disorder

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From two weeks to three months after traumatic brain injury

Secondary outcomes

  1. the relationship between gut microbiota and circadian rhythm of patients with TBI

    the relationship between gut microbiota and circadian rhythm of patients with TBI

    Time frame: From two weeks to three months after traumatic brain injury

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Study locations

1 of 1 sites recruiting
  • General Hospital of Ningxia Medical University
    Yinchuan, Ningxia 750004, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02849028
Responsible party
Sponsor
First posted
Jul 29, 2016
Start date
Jul 2016
Primary completion
Dec 2016 (estimated)
Completion
Dec 2016 (estimated)
Last update
Jul 29, 2016

Study contacts

Xia Hechun, Bachelor
Contact
Xhechun@aliyun.com
8613995199559
Xia Hechun, Bachelor
study director · The General Hospital of Ningxia Medical University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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