Traumatic Brain Injury and the Gut Microbiome

Centre for Neuro Skills (CNS)

Status

Completed

Conditions

Brain Injury, Chronic

Brain Injuries, Traumatic

Treatments

Dietary Supplement: Inulin fructooligosaccharide

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04949607

Pro00054911

Details and patient eligibility

About

The purpose of the study is to determine whether administration of a prebiotic, inulin, can improve the symptom complex associated with traumatic brain injury and whether inulin administration can alter the bacteria that live in the gut.

Full description

The investigators will study subjects (aged 18-70 years) with a history of moderate/severe traumatic brain injury (n=10) and healthy controls (aged 18-70 years) (n=10). All subjects will undergo a 3-month intervention of oral inulin treatment. The traumatic brain injury subjects will be administered oral inulin twice daily for 3 months. Testing including cognitive function assessment (Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), and questionnaires of fatigue, mood and quality of life and sleep will occur at month 0, 3 and 6. Blood sampling for measurement of amino acid levels, hormones, short chain fatty acids and markers of neuroinflammation will be drawn before and 90 minutes (+/- 10 minutes) after a standardized meal will occur at month 0 and month 3. In addition, fecal samples for analysis of the GI microbiome will be collected at month -1, month 0, month 1, month 2, month 3, and month 6 along with an assessment of gastrointestinal health. Traumatic brain injury subjects will be selected from residents at a long term residential rehabilitation center. Healthy control subjects will be administered oral inulin twice daily with meals for 3 months. Quality of life will be assessed by questionnaires at months 0, 3 and 6. Blood sampling for measurement of amino acid levels, hormones, short chain fatty acids and markers of neuroinflammation will be drawn before and 90 minutes (+/- 10 minutes) after a standardized meal will occur at month 0 and month 3. Fecal samples will be collected at month -1, month 0, month 3 and month 6 for analysis of the GI microbiome along with an assessment of gastrointestinal health. A member of the study team will check monthly for adverse events and overall well-being and ensure compliance and ongoing consent.

Enrollment

23 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

-Traumatic Brain Injury

Head trauma greater than two years prior manifesting in one or more of the following:

Loss of consciousness
Post-traumatic amnesia
Focal neurologic deficits
Seizures
Persistent symptoms of increased arousal (e.g., difficulty falling or staying asleep, anger and hypervigilance)
Impairment in cognitive, social, occupational, or other important areas of functioning (e.g., problems with work and relationships)

Exclusion criteria

Traumatic Brain Injury
1. Unwilling to give consent. Patients with rights managed by Legal Authorized Representative must consent to participate in addition to consent from their legal agent
2. < 2 years post-injury
3. Known allergy to study agent.
4. Other medical condition or medication administration deemed exclusionary by the study investigators.
  
  Inclusion Criteria:
Healthy Control
1. Ages 18 to 70 years
2. Works at Centre for Neuro Skills
3. Participant is willing and able to give informed consent for participation in the study.
  
  Exclusion Criteria
Healthy Control
1. Subjects with a history of inflammatory bowel disease, Celiac disease or active diverticular disease.
2. Known allergy to study agent.
3. Other medical condition or medication administration deemed exclusionary by the study investigators.