Brain InjuriesMicrobiomeSupplementsNutrition and dietCognitive functionDietary supplement
What this study is
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.
What's being tested
- Inulin
Intervention · DIETARY SUPPLEMENT
Inulin, 4g twice daily for 42 days
Study details
- Sponsor
- The University of Texas Medical Branch, Galveston
- Conditions
- Brain Injuries
- Enrolling
- 130 people
- Starts
- 2025-03-06
- Est. completion
- 2028-10-01
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers AcceptedYou may qualify if
- Brain Injury Patients
- 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)
- 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
You can't join if
- 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
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
1
Study locations (1)
1 openUniversity of Texas Medical Branch
Galveston, Texas, United States
- Kate M Randolph, BS · Contact409-772-8126kmrandol@utmb.edu
- Christopher P Danesi, MS · Contact409-772-8126cpdanesi@utmb.edu
- Randall J Urban, MD · Principal investigator
Recruiting
Study team
Sponsor
The University of Texas Medical Branch, Galveston
Study ID 24-0237
Principal investigator
Randall Urban, MD
University of Texas
Study director
Ana Durand, MD
Moody Neurorehabilitation Institute
Have questions? The contacts above can answer them before you apply.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.