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Association of Amino Acid Prevalence and Chronic Brain Injury

NCT ID: NCT02113124

Last Updated: 2015-12-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

43 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-12-31

Brief Summary

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Years after a suffering a brain injury, individuals remain in a physically and cognitively impaired state. The investigators believe that the concentrations of amino acids in the blood are chronically altered and yield negative effects on the individuals health. Preliminary data has shown significantly lower concentrations of amino acids in serum samples from the TBI population, these diminished levels of amino acids may be due to changes in the microbiome. Understanding these changes will help guide rehabilitative services for this population. Individuals with a chronic brain injury will donate samples of blood, oral tissue, and fecal matter to be compared to that of non-injured individuals. Genetic information from the hosts will be striped and discarded; participant's genetic information will not be retained. To better understand changes in the microbiome, any history of antibiotics and probiotics will be assessed.

Detailed Description

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The purpose of this study is to evaluate the levels of Amino Acids in adult individuals with chronic (\> 2 years) traumatic brain injury (TBI) when compared to a non-brain injured cohort population.

Preliminary data from an assay of amino acids in individuals with chronic TBI compared to an assay of individuals without a TBI revealed significantly lower concentrations of amino acids within the TBI group.

The composition and structure of the oral and fecal microbiome will be determined by 16S rDNA sequencing. Taxonomic and community structure profiles will be treated as outcome variables and modeled together with the participant's plasma amino acid concentration, years post-injury, age, sex and other variables to determine correlations. These correlations may improve our understanding of the diminished amino acid metabolism within the chronic TBI population.

The endpoint will identify the microbiome structure and composition by 16S rRNA gene sequencing within the TBI and healthy participants and to assess the participant's amino acid concentrations and other participant demographics and phenotypic characteristics (years post-injury, age, sex). This comparison may improve our understanding of the diminished amino acid metabolism within the chronic TBI population.

Conditions

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Chronic Traumatic Brain Injury

Keywords

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Chronic Brain Injury Traumatic brain injury (TBI) Amino Acids Microbiome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Chronic brain injury

Individuals in this group have suffered a brain injury more than 2 years prior to study. Ages range from 21 to 70.

No interventions assigned to this group

Uninjured control

This group of individuals have no history of brain injury. Ages range between 21 and 70.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Willing to donate 10 ml of blood
* Willing to donate oral tissue sample
* Willing to donate fecal sample

Exclusion Criteria

* (for brain injured group) have a chronic (greater than two years) traumatic brain injury.
* Unable to provide to give voluntary informed consent
Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Moody Foundation

OTHER

Sponsor Role collaborator

Brent Masel

OTHER

Sponsor Role lead

Responsible Party

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Brent Masel

Brent Masel, M.D.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Brent E Masel, MD

Role: PRINCIPAL_INVESTIGATOR

Transitional Learning Center

Locations

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Centre for Neuro Skills

Bakersfield, California, United States

Site Status

Centre for Neuro Skills

Dallas, Texas, United States

Site Status

Transitional Learning Center

Galveston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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TLC IRB #200

Identifier Type: -

Identifier Source: org_study_id