Recruiting

Prebiotic Treatment

Sponsor:

The University of Texas Medical Branch, Galveston

Code:

NCT06607523

Conditions

Brain Injuries

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Inulin

Study Details

Brief 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.

Conditions

Brain Injuries

Study ID

NCT06607523

Start date

Mar 6, 2025

Status verified date

Dec, 2025

Completion date

Oct 1, 2028

Anticipated

Primary completion date

Oct 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

130 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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).

Interventions

Inulin

Inulin, 4g twice daily for 42 days

Primary outcome measure

  • Quantify absolute abundance of gut microbiome using metagenomic analysis at baseline [ Time Frame: baseline ]
  • Quantify absolute abundance of gut microbiome using metagenomic analysis after 42 days of inulin supplementation [ Time Frame: 42 days inulin treatment ]
  • Quantify absolute abundance of gut microbiome using metagenomic analysis at 3 months of discontinuation of inulin [ Time Frame: 3 months of discontinuation of inulin ]
  • Quantify absolute abundance of gut microbiome using metagenomic analysis at 6 months of discontinuation of inulin [ Time Frame: 6 months of discontinuation of inulin ]
  • Fold change in relative abundance of gut microbiome using metatranscriptomic analysis from baseline to 42 days of inulin treatment [ Time Frame: From baseline to 42 days of inulin treatment ]
  • Fold change in relative abundance of gut microbiome using metatranscriptomic analysis from baseline to 3 months after discontinuation of inulin treatment [ Time Frame: From baseline to 3 months after discontinuation of inulin treatment ]
  • Fold change in relative abundance of gut microbiome using metatranscriptomic analysis from baseline to 6 months after discontinuation of inulin treatment [ Time Frame: From baseline to 6 months after discontinuation of inulin treatment ]

Central Contacts and Locations

Central contacts

Kate Randolph, BS

409-772-8126kmrandol@utmb.edu

Christopher Danesi, MS

409-772-8126cpdanesi@utmb.edu

Locations

University of Texas Medical Branch

Recruiting

Galveston, Texas, United States, 77555

Contacts

Kate M Randolph, BS

409-772-8126kmrandol@utmb.edu

Christopher P Danesi, MS

409-772-8126cpdanesi@utmb.edu

Principal Investigator:

Randall J Urban, MD

More Information

Sponsor

The University of Texas Medical Branch, Galveston

Last update posted

Dec 19, 2025

Last verified

Dec, 2025

Keywords

  • Brain Injury
  • Neurorehabilitation
  • Fatigue
  • Cognition

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Medical Branch, Galveston on 2025-12-19.