Prebiotic treatment to improve gut health and brain function after injury
Official title: The Gut-Brain Axis During Neurorehabilitation; Prebiotic Treatment to Alter the Gut Microbiome and Neurologic Symptoms
Run by The University of Texas Medical Branch, Galveston · NCT06607523 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 130 (estimated) |
| Sponsor | The University of Texas Medical Branch, Galveston Academic / other |
| Locations | 1 site (Galveston, Texas) |
| Status | Recruiting |
| Started | March 6, 2025 |
| Main results expected | October 1, 2028 |
| Study ends | October 1, 2028 |
| Registry record updated | December 19, 2025 |
| Trial ID | NCT06607523 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.