This trial is active, not recruiting.

Condition chronic traumatic brain injury
Sponsor Brent Masel
Collaborator The Moody Foundation
Start date December 2013
End date December 2015
Trial size 41 participants
Trial identifier NCT02113124, TLC IRB #200


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective cross-sectional
Individuals in this group have suffered a brain injury more than 2 years prior to study. Ages range from 35 to 70.
This group of individuals have no history of brain injury. Ages range between 35 and 70.

Primary Outcomes

Change from baseline of concentrations of essential amino acid at 1.5 hours after eating
time frame: Samples taken following 8 hour fasting period and again 90 minutes after eating a predetermined meal
Bioinformatic analysis of oral and gastrointestinal microbiome
time frame: Samples will be collected once consent is given (day 1). Participation in this study ceases after sample collection.

Eligibility Criteria

Male or female participants from 35 years up to 70 years old.

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

Additional Information

Official title Association of Amino Acid Prevalence and Chronic Brain Injury
Principal investigator Brent E Masel, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by The Transitional Learning Center, Galveston, TX.