NCT06607523 The Gut-Brain Axis During Neurorehabilitation; Prebiotic Treatment to Alter the Gut Microbiome and Neurologic Symptoms
| NCT ID | NCT06607523 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The University of Texas Medical Branch, Galveston |
| Condition | Brain Injuries |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2025-03-06 |
| Primary Completion | 2028-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 130 participants in total. It began in 2025-03-06 with a primary completion date of 2028-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of this study is to characterize the microbiome of patients undergoing post-acute residential neurorehabilitation compared to community controls and to determine if a dietary fiber, Inulin, can create a shift in the microbiome leading to changes in fatigue and cognition.
Eligibility 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
Contact & Investigator
Randall Urban, MD
PRINCIPAL INVESTIGATOR
University of Texas
Frequently Asked Questions
Who can join the NCT06607523 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Brain Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06607523 currently recruiting?
Yes, NCT06607523 is actively recruiting participants. Contact the research team at kmrandol@utmb.edu for enrollment information.
Where is the NCT06607523 trial being conducted?
This trial is being conducted at Galveston, United States.
Who is sponsoring the NCT06607523 clinical trial?
NCT06607523 is sponsored by The University of Texas Medical Branch, Galveston. The principal investigator is Randall Urban, MD at University of Texas. The trial plans to enroll 130 participants.