Traumatic Brain Injury and the Gut Microbiome

NCT04949607 | Completed

• 1 other identifier: Pro00054911
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injury, Chronic; Brain Injuries, Traumatic

Outcome Measures

Primary Outcomes (5)

• Characterization of fecal microbiome using molecular methods at baseline

  Characterization of the fecal microbiome using a commercially available sampling kit and our lab's patented array for Polymerase Chain Reaction.

  Baseline

• Characterization of fecal microbiome using molecular methods at month 1

  Characterization of the fecal microbiome using a commercially available sampling kit and our lab's patented array for Polymerase Chain Reaction.

  month 1

• Characterization of fecal microbiome using molecular methods at month 2

  Characterization of the fecal microbiome using a commercially available sampling kit and our lab's patented array for Polymerase Chain Reaction.

  month 2

• Characterization of fecal microbiome using molecular methods at month 3

  Characterization of the fecal microbiome using a commercially available sampling kit and our lab's patented array for Polymerase Chain Reaction.

  month 3

• Characterization of fecal microbiome using molecular methods at month 6

  Characterization of the fecal microbiome using a commercially available sampling kit and our lab's patented array for Polymerase Chain Reaction.

  month 6

Secondary Outcomes (108)

• Sleep Quality as measured by Pittsburgh Sleep Quality Index at baseline

  Baseline (month 0)

• Sleep Quality as measured by Pittsburgh Sleep Quality Index at month 3

  month 3

• Sleep Quality as measured by Pittsburgh Sleep Quality Index at month 6

  month 6

• Symptoms of Growth Hormone Deficiency measured by the questionnaire Quality of Life - Assessment of Growth Hormone Deficiency in Adults at baseline

  Baseline (month 0)

• Symptoms of Growth Hormone Deficiency measured by the questionnaire Quality of Life - Assessment of Growth Hormone Deficiency in Adults at month 3

  month 3

Study Arms (2)

Chronic Traumatic Brain Injury

EXPERIMENTAL

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

Dietary Supplement: Inulin fructooligosaccharide

Healthy Controls

EXPERIMENTAL

Healthy subjects aged 18-70 years receiving Inulin treatment.

Dietary Supplement: Inulin fructooligosaccharide

Interventions

Inulin fructooligosaccharide 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.

Chronic Traumatic Brain Injury; Healthy Controls

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Traumatic Brain Injury
• 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 years post-injury
• Known allergy to study agent.
• Healthy Control
• Ages 18 to 70 years
• Works at Centre for Neuro Skills
• Participant is willing and able to give informed consent for participation in the study.
• Healthy Control
• Subjects with a history of inflammatory bowel disease, Celiac disease or active diverticular disease.
• Known allergy to study agent.

Sponsors & Collaborators

• Centre for Neuro Skills: lead
• University of Texas: collaborator

Study Sites (1)

Centre for Neuro Skills

Bakersfield, California, 93313, United States

Location

MeSH Terms

Conditions

Brain Injury, Chronic; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• Brent Masel, MD

  Centre for Neuro Skills

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be administered 1-4 grams of Inulin twice daily for 3 months.

Study Record Dates

• First Submitted: June 25, 2021
• First Posted: July 2, 2021
• Study Start: July 28, 2021
• Primary Completion: June 8, 2022
• Study Completion: June 8, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)