Status:
RECRUITING
The Gut-Brain Axis During Neurorehabilitation; Prebiotic Treatment to Alter the Gut Microbiome and Neurologic Symptoms
Lead Sponsor:
The University of Texas Medical Branch, Galveston
Collaborating Sponsors:
Moody Neurorehabilitation Institute
Conditions:
Brain Injuries
Eligibility:
All Genders
18+ years
Phase:
NA
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, ca...
Detailed Description
The investigative research team previously described Brain Injury Associated Fatigue and Altered Cognition (BIAFAC) as a treatable syndrome that occurs in a subset of patients following traumatic brai...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT06607523
Start Date
March 6 2025
End Date
October 1 2028
Last Update
December 19 2025
Active Locations (1)
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1
University of Texas Medical Branch
Galveston, Texas, United States, 77555