RecruitingNot ApplicableNCT06607523
The Gut-Brain Axis During Neurorehabilitation; Prebiotic Treatment to Alter the Gut Microbiome and Neurologic Symptoms
Sponsor
The University of Texas Medical Branch, Galveston
Enrollment
130 participants
Start Date
Mar 6, 2025
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria36
- 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
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Interventions
DIETARY_SUPPLEMENTInulin
Inulin, 4g twice daily for 42 days
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06607523
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