NCT02874027

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 22, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Last Updated

August 23, 2016

Status Verified

August 1, 2016

Enrollment Period

9 months

First QC Date

August 17, 2016

Last Update Submit

August 21, 2016

Conditions

Traumatic Brain Injury With Brief Loss of Consciousness

Keywords

gut microbiotadepressiongut-brain axiscircadian rhythmTraumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

  • the relationship between depression and circadian rhythm of patients with TBI

    From three months to six months after traumatic brain injury

Secondary Outcomes (1)

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

    From three months to six months after traumatic brain injury

Study Arms (2)

TBI Patients with depression

All the patients should be diagnosed by CCMD-3(evaluation of depression)

Other: The TBI patients with depression

TBI Patients without depression

Other: The TBI patients with depression

Interventions

The TBI patients with depressionOTHER

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

TBI Patients with depressionTBI Patients without depression

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The number of patients is 25 and the health people is 25.

You may qualify if:

  • 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)
  • clinical diagnosis of depression

You may not qualify if:

  • the moderate and severe TBI patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

RECRUITING

MeSH Terms

Conditions

DepressionBrain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Xia Hechun, Bachelor

    General Hospital of Ningxia Medical University

    STUDY DIRECTOR

Central Study Contacts

Xia hechun, Bachelor

CONTACT

8613995109559xhechun@aliyun.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2016

First Posted

August 22, 2016

Study Start

August 1, 2016

Primary Completion

May 1, 2017

Last Updated

August 23, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)