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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Texas Medical Branch, Galveston

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Ages 18 and above

Admitted to Moody Neurorehabilitation Institute for care

Less than 6 months post-injury

English speaking

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Inulin

    Dietary supplement

    Inulin, 4g twice daily for 42 days

Treatment groups

130 Participants
are divided into 3 treatment groups
Group A: Community ControlsNo intervention 0 interventions
Group B: Brain Injury Patients - no interventionNo intervention 0 interventions
Group C: Brain Injury Patients - inulin interventionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
baseline
2

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.

Time frame
42 days inulin treatment
3

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.

Time frame
3 months of discontinuation of inulin
4

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.

Time frame
6 months of discontinuation of inulin

Secondary outcomes

1

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

The Fatigue and Altered Cognition Scale (FACS) is a joint project from University of Texas Medical Branch and Texas A\&M University. The FACS is a 20 question assessment designed to access perceived fatigue and cognition. There are 2 subscales used to calculate a total score. The subscales are: Fatigue and Altered Cognition. The total score is calculated by adding the subscales together. The range of the total score is 0-100, with a higher score indicating more fatigue and altered cognition.

Time frame
baseline
2

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

The Fatigue and Altered Cognition Scale (FACS) is a joint project from University of Texas Medical Branch and Texas A\&M University. The FACS is a 20 question assessment designed to access perceived fatigue and cognition. There are 2 subscales used to calculate a total score. The subscales are: Fatigue and Altered Cognition. The total score is calculated by adding the subscales together. The range of the total score is 0-100, with a higher score indicating more fatigue and altered cognition.

Time frame
42 days of inulin treatment
3

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

The Fatigue and Altered Cognition Scale (FACS) is a joint project from University of Texas Medical Branch and Texas A\&M University. The FACS is a 20 question assessment designed to access perceived fatigue and cognition. There are 2 subscales used to calculate a total score. The subscales are: Fatigue and Altered Cognition. The total score is calculated by adding the subscales together. The range of the total score is 0-100, with a higher score indicating more fatigue and altered cognition.

Time frame
3 months discontinuation of inulin
4

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

The Fatigue and Altered Cognition Scale (FACS) is a joint project from University of Texas Medical Branch and Texas A\&M University. The FACS is a 20 question assessment designed to access perceived fatigue and cognition. There are 2 subscales used to calculate a total score. The subscales are: Fatigue and Altered Cognition. The total score is calculated by adding the subscales together. The range of the total score is 0-100, with a higher score indicating more fatigue and altered cognition.

Time frame
6 months discontinuation of inulin

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Medical Branch, Galveston

Lead sponsor

Moody Neurorehabilitation Institute

Collaborator