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

NCT06607523 | Recruiting

• 1 other identifier: 24-0237
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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

Keywords

Brain Injury; Neurorehabilitation; Fatigue; Cognition

Outcome Measures

Primary Outcomes (7)

• Quantify absolute abundance of gut microbiome using metagenomic analysis at baseline

  Metagenomic analysis using a custom PCR array will be performed on stool samples to identify associated changes in microbiome absolute abundance at the genus and species level.

  baseline

• Quantify absolute abundance of gut microbiome using metagenomic analysis after 42 days of inulin supplementation

  Metagenomic analysis using a custom PCR array will be performed on stool samples to identify associated changes in microbiome absolute abundance at the genus and species level.

  42 days inulin treatment

• Quantify absolute abundance of gut microbiome using metagenomic analysis at 3 months of discontinuation of inulin

  Metagenomic analysis using a custom PCR array will be performed on stool samples to identify associated changes in microbiome absolute abundance at the genus and species level.

  3 months of discontinuation of inulin

• Quantify absolute abundance of gut microbiome using metagenomic analysis at 6 months of discontinuation of inulin

  Metagenomic analysis using a custom PCR array will be performed on stool samples to identify associated changes in microbiome absolute abundance at the genus and species level.

  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

  Metatranscriptomic analysis using a RNA seq will be performed on stool samples to identify associated fold changes in which genes are turned on and off.

  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

  Metatranscriptomic analysis using a RNA seq will be performed on stool samples to identify associated fold changes in which genes are turned on and off.

  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

  Metatranscriptomic analysis using a RNA seq will be performed on stool samples to identify associated fold changes in which genes are turned on and off.

  From baseline to 6 months after discontinuation of inulin treatment

Secondary Outcomes (4)

• Fatigue and Cognition as measured by the Fatigue and Altered Cognition Scale at baseline

  baseline

• Fatigue and Cognition as measured by the Fatigue and Altered Cognition Scale after 42 days of inulin treatment

  42 days of inulin treatment

• Fatigue and Cognition as measured by the Fatigue and Altered Cognition Scale at 3 months after discontinuation of inulin

  3 months discontinuation of inulin

• Fatigue and Cognition as measured by the Fatigue and Altered Cognition Scale at 6 months discontinuation of inulin

  6 months discontinuation of inulin

Study Arms (3)

Community Controls

NO INTERVENTION

Community Control subjects will not receive intervention.

Brain Injury Patients - no intervention

NO INTERVENTION

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

Brain Injury Patients - inulin intervention

ACTIVE COMPARATOR

Brain injury patients receiving residential standard of care post-acute neurorehabilitation plus 42 days of daily oral inulin supplementation (4g 2x daily).

Dietary Supplement: Inulin

Interventions

Inulin DIETARY_SUPPLEMENT

Inulin, 4g twice daily for 42 days

Brain Injury Patients - inulin intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Moody Neurorehabilitation Institute: collaborator
• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries; Fatigue

Interventions

Inulin

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Fructans; Polysaccharides

Study Officials

• Randall Urban, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

• Ana Durand, MD

  Moody Neurorehabilitation Institute

  STUDY DIRECTOR

Central Study Contacts

Kate Randolph, BS

CONTACT

409-772-8126; kmrandol@utmb.edu

Christopher Danesi, MS

CONTACT

409-772-8126; cpdanesi@utmb.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 23, 2024
• Study Start: March 6, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)