N/A N=43

Association of Amino Acid Prevalence and Chronic Brain Injury

Chronic Traumatic Brain Injury

Bottom Line

View on ClinicalTrials.gov: NCT02113124 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2015

Primary outcome: Primary: Change From Baseline of Concentrations of Essential Amino Acid at 1.5 Hours After Eating — 487.28; 553.70; 1224.19; 1339.54 µM

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: —
Age: Adult, Older Adult · 35+ yrs
Sex: All
Sponsor: Brent Masel
Primary completion: Dec 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline of Concentrations of Essential Amino Acid at 1.5 Hours After Eating	487.28; 553.70; 1224.19; 1339.54	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02113124). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.