Clinical trial NCT02113124: Association of Amino Acid Prevalence and Chronic Brain Injury
Official title: Association of Amino Acid Prevalence and Chronic Brain Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Traumatic Brain Injury
Keywords: Chronic Brain Injury
Traumatic brain injury (TBI)
Amino Acids
Microbiome
Lead sponsor: The Transitional Learning Center, Galveston, TX
Sponsor class: OTHER
Collaborators: name: The Moody Foundation
First posted: 2014-04-14
Enrollment: 43
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals in the chronic brain injured group are recruited from traumatic brain injury rehabilitation facilities. These facilities include Tideway in Galveston, Texas, Centre for Neuro Skills in Bakersfield, CA, and Centre for Neuro Skills in Dallas, TX. The cohorts for this study will be recruited from the communities surrounding the rehabilitation facilities.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline of Concentrations of Essential Amino Acid at 1.5 Hours After Eating
timeFrame: Samples collected on day 1 following 8 hour fasting period and again 90 minutes after eating a predetermined meal
Secondary outcomes:
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Centre for Neuro Skills
state: California
city: Dallas
country: United States
facility: Centre for Neuro Skills
state: Texas
city: Galveston
country: United States
facility: Transitional Learning Center
state: Texas
Study officials:
affiliation: Transitional Learning Center
name: Brent E Masel, MD
role: PRINCIPAL_INVESTIGATOR
References: