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

Part of paid clinical trials in Galveston, Texas.

Sponsor
The University of Texas Medical Branch, Galveston
Study ID
NCT06607523
Status
Recruiting
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Conditions

  • Brain Injuries

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Inulin — DIETARY_SUPPLEMENT
    Inulin, 4g twice daily for 42 days

Study Details

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.

Key Dates

Start date
Mar 6, 2025
Status verified
Dec 2025
Primary completion
Oct 1, 2028
Completion
Oct 1, 2028

Study Design

Enrollment
130 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Community Controls
    Community Control subjects will not receive intervention.
  • No Intervention: Brain Injury Patients - no intervention
    Brain injury patients receiving residential standard of care post-acute neurorehabilitation.
  • Active Comparator: Brain Injury Patients - inulin intervention
    Brain injury patients receiving residential standard of care post-acute neurorehabilitation plus 42 days of daily oral inulin supplementation (4g 2x daily).

Primary Outcome Measure

Quantify absolute abundance of gut microbiome using metagenomic analysis at baseline [ Time Frame: baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas Medical BranchGalvestonTexas77555
Kate M Randolph, BS
[email protected]
409-772-8126
Christopher P Danesi, MS
[email protected]
409-772-8126
Randall J Urban, MD (PRINCIPAL_INVESTIGATOR)

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