Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06607523

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

Led by The University of Texas Medical Branch, Galveston · Updated on 2025-12-19

130

Participants Needed

1

Research Sites

186 weeks

Total Duration

On this page

Sponsors

T

The University of Texas Medical Branch, Galveston

Lead Sponsor

M

Moody Neurorehabilitation Institute

Collaborating Sponsor

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 64 50
Not Eligible

You will not qualify if you...

  • 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
  • Trauma to head in last 6 months
  • Stroke in last 6 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Texas Medical Branch

Galveston, Texas, United States, 77555

Actively Recruiting

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Research Team

K

Kate Randolph, BS

CONTACT

C

Christopher Danesi, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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