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

NCT ID: NCT06607523

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-06

Study Completion Date

2028-10-01

Brief Summary

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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.

Detailed Description

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The investigative research team previously described Brain Injury Associated Fatigue and Altered Cognition (BIAFAC) as a treatable syndrome that occurs in a subset of patients following traumatic brain injury (TBI). In addition to fatigue and brain fog, BIAFAC patients have altered growth hormone (GH) secretion, reduced serum amino acid levels, and an altered (dysbiotic) gut microbiome. GH treatment dramatically improves patient symptoms but is not curative; symptoms return when GH treatment ends and the associated gut dysbiosis is not corrected. In preliminary work with mouse models created using human fecal transplants from clinical BIAFAC subjects, transplanting the dysbiotic gut bacteria from BIAFAC patients alone caused fatigue, altered cognition, and dysregulated GH secretion without any trauma or head injury. These mouse models indicate that gut dysbiosis has a causative role in the development of BIAFAC by triggering both altered GH secretion and neurologic symptoms. In this clinical trial a dietary fiber, Inulin, will be administered to patients undergoing neurorehabilitation after brain injury to create a shift in their microbiome.

Specific Aims

Aim 1. Identify differences in blood and fecal microbiome biomarkers of neurorehabilitation patients.

Specific Aim 1a. Identify differences in blood and fecal microbiome biomarkers between patients entering an inpatient post-acute neurorehabilitation program and community controls.

Specific Aim 1b. Identify correlations between biomarkers (blood and fecal microbiome), demographics (e.g. age, sex), and clinical factors (e.g. medical history) of post-acute neurorehabilitation patients.

Specific Aim 1c. Document longitudinal change in blood and fecal microbiome biomarkers of patients during inpatient post-acute neurorehabilitation.

Aim 2. Determine the effect of dietary inulin supplement on patients undergoing post-acute neurorehabilitation.

Specific Aim 2a. Determine how dietary inulin supplementation impacts the gut microbiome profile and function in brain injury patients during inpatient post-acute neurorehabilitation.

Specific Aim 2b. Determine if dietary inulin supplementation affects fatigue and cognition in patients during inpatient post-acute neurorehabilitation.

Aim 3. Determine if short-term early intervention dietary inulin supplementation during post-acute neurorehabilitation affects longer-term patient-reported outcomes.

Conditions

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Brain Injuries

Keywords

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Brain Injury Neurorehabilitation Fatigue Cognition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Community Controls

Community Control subjects will not receive intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Brain Injury Patients - no intervention

Brain injury patients receiving residential standard of care post-acute neurorehabilitation.

Group Type NO_INTERVENTION

No interventions assigned to this group

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).

Group Type ACTIVE_COMPARATOR

Inulin

Intervention Type DIETARY_SUPPLEMENT

Inulin, 4g twice daily for 42 days

Interventions

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Inulin

Inulin, 4g twice daily for 42 days

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Moody Neurorehabilitation Institute

UNKNOWN

Sponsor Role collaborator

The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Randall Urban, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Ana Durand, MD

Role: STUDY_DIRECTOR

Moody Neurorehabilitation Institute

Locations

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University of Texas Medical Branch

Galveston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kate Randolph, BS

Role: CONTACT

Phone: 409-772-8126

Email: [email protected]

Christopher Danesi, MS

Role: CONTACT

Phone: 409-772-8126

Email: [email protected]

Facility Contacts

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Kate M Randolph, BS

Role: primary

Christopher P Danesi, MS

Role: backup

Other Identifiers

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24-0237

Identifier Type: -

Identifier Source: org_study_id