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The Gut-Brain Axis During Neurorehabilitation; Prebiotic Treatment to Alter the Gut Microbiome and Neurologic Symptoms

The University of Texas Medical Branch, Galveston · with Moody Neurorehabilitation Institute · NCT06607523

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
130
US sites recruiting
1
Study start
March 6, 2025
Record last updated
December 19, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Inulin

Conditions: Brain Injuries

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • University of Texas Medical Branch

    Galveston, TX 77555

    Site contact: Kate M Randolph, BS · 409-772-8126 · kmrandol@utmb.edu

Study contacts (from the official record)

  • Kate Randolph, BS · 409-772-8126 · kmrandol@utmb.edu
  • Christopher Danesi, MS · 409-772-8126 · cpdanesi@utmb.edu
All healthy volunteers studies in Texas →
The Gut-Brain Axis During Neurorehabilitation; Prebiotic Treatment… (NCT06607523) | Bored Studies