Traumatic Brain Injury and the Gut Microbiome

NCT ID: NCT04949607

Last Updated: 2022-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-28
• Study Completion Date: 2022-06-08

Brief Summary

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.

Detailed 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.

Conditions

Brain Injury, Chronic; Brain Injuries, Traumatic

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chronic Traumatic Brain Injury

Subjects aged 18-70 years with chronic traumatic brain injury receiving Inulin treatment.

Group Type: EXPERIMENTAL

Inulin fructooligosaccharide

Intervention Type: DIETARY_SUPPLEMENT

Subjects will be administered inulin at a starting dose of 1g twice daily (2g/day) and ramping up an additional 2g/day until the final dose of 4g twice daily (8g/day), which will continue on until the end of month 3 (week 12). After the month 3 study visit, inulin dosing will begin to ramp down over the next week.

Healthy Controls

Healthy subjects aged 18-70 years receiving Inulin treatment.

Group Type: EXPERIMENTAL

Inulin fructooligosaccharide

Intervention Type: DIETARY_SUPPLEMENT

Subjects will be administered inulin at a starting dose of 1g twice daily (2g/day) and ramping up an additional 2g/day until the final dose of 4g twice daily (8g/day), which will continue on until the end of month 3 (week 12). After the month 3 study visit, inulin dosing will begin to ramp down over the next week.

Interventions

Inulin fructooligosaccharide

Subjects will be administered inulin at a starting dose of 1g twice daily (2g/day) and ramping up an additional 2g/day until the final dose of 4g twice daily (8g/day), which will continue on until the end of month 3 (week 12). After the month 3 study visit, inulin dosing will begin to ramp down over the next week.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

-Traumatic Brain Injury

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

1. Loss of consciousness

2. Post-traumatic amnesia

3. Focal neurologic deficits

4. Seizures

5. Persistent symptoms of increased arousal (e.g., difficulty falling or staying asleep, anger and hypervigilance)

6. Impairment in cognitive, social, occupational, or other important areas of functioning (e.g., problems with work and relationships)

• 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

• 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.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Texas

OTHER

Sponsor Role: collaborator

Centre for Neuro Skills

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brent Masel, MD

Role: PRINCIPAL_INVESTIGATOR

Centre for Neuro Skills

Locations

Centre for Neuro Skills

Bakersfield, California, United States

Countries

United States

Other Identifiers

Pro00054911

Identifier Type: -

Identifier Source: org_study_id