Prebiotic treatment to improve gut health and brain function after injury
The Gut-Brain Axis During Neurorehabilitation; Prebiotic Treatment to Alter the Gut Microbiome and Neurologic Symptoms
This study is testing if a type of dietary fiber called Inulin can improve gut health and help reduce fatigue and cognitive problems in people recovering from brain injuries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Texas Medical Branch, Galveston Academic / other |
| Locations | 1 site (Galveston, Texas) |
| Trial ID | NCT06607523 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the gut microbiome of patients undergoing neurorehabilitation after brain injuries and to assess whether the dietary fiber Inulin can positively alter their microbiome. The research focuses on patients with Brain Injury Associated Fatigue and Altered Cognition (BIAFAC), a syndrome linked to traumatic brain injury. By comparing microbiome biomarkers in these patients to community controls, the study seeks to establish correlations between gut health and neurological symptoms. The ultimate goal is to determine if Inulin can alleviate fatigue and cognitive issues in these patients.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and above who are less than six months post-brain injury and admitted to the Moody Neurorehabilitation Institute.
Not a fit: Patients with significant comorbidities, such as severe heart or liver disease, or those with a history of inflammatory bowel disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve fatigue and cognitive function in patients recovering from brain injuries.
How similar studies have performed: While the approach of using prebiotics to alter the gut microbiome is gaining interest, this specific application in neurorehabilitation is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Brain Injury Patients Inclusion * Ages 18 and above * Admitted to Moody Neurorehabilitation Institute for care * Less than 6 months post-injury * English speaking * Must be able to eat and drink by mouth * Willing and able to comply with study procedures * Willing and able to provide consent (with LAR if needed) Exclusion * Significant heart, liver, kidney, blood or respiratory disease * HIV, Hepatitis B or Hepatitis C * Pregnancy or becoming pregnant during the study * History of inflammatory bowel disease * History of celiac disease * Active diverticular disease * Known allergy to study agent * Any medical condition that, in the opinion of the investigator, would place the subject at increased risk for participation Community Control Subjects Inclusion * Ages 18 and above * Have a family member who is admitted to Moody Neurorehabilitation Institute for care OR is working at Moody Neurorehabilitation Institute * English speaking * Willing and able to comply with study procedures * Willing and able to provide consent * FACs score ≤ 50 Exclusion * Trauma to head in last 6 months * Stroke in last 6 months * Significant heart, liver, kidney, blood or respiratory disease * HIV, Hepatitis B or Hepatitis C * Pregnancy or becoming pregnant during the study * History of inflammatory bowel disease * History of celiac disease * Active diverticular disease * Any medical condition that, in the opinion of the investigator, would place the subject at increased risk for participation
Where this trial is running
Galveston, Texas
- University of Texas Medical Branch — Galveston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Randall Urban, MD — University of Texas
- Study coordinator: Kate Randolph, BS
- Email: kmrandol@utmb.edu
- Phone: 409-772-8126
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.