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Prebiotic

Inulin for Traumatic Brain Injury

N/A

Waitlist Available

Led By Randall Urban, MD

Research Sponsored by The University of Texas Medical Branch, Galveston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ages 18 and above

Be older than 18 years old

Must not have

Active diverticular disease

Stroke in last 6 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months discontinuation of inulin

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to study the bacteria in the gut of patients recovering from neurorehabilitation and compare it with people in the community. The study will also investigate if taking a dietary fiber supplement called In

Who is the study for?

This trial is for individuals in post-acute residential neurorehabilitation after a traumatic brain injury. It's designed to see if their gut bacteria (microbiome) can be altered by a dietary fiber called Inulin, which might help with fatigue and thinking problems.

What is being tested?

The study tests whether taking Inulin, a type of dietary fiber, changes the gut microbiome and improves neurological symptoms like fatigue and cognition in people recovering from traumatic brain injuries.

What are the potential side effects?

Inulin may cause digestive side effects such as bloating, gas, discomfort, or an upset stomach due to its nature as a dietary fiber.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have active diverticular disease.

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I have not had a stroke in the last 6 months.

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I do not have serious heart, liver, kidney, blood, or lung conditions.

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I do not have HIV, Hepatitis B, or Hepatitis C.

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I have a history of inflammatory bowel disease.

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I have been diagnosed with celiac disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months discontinuation of inulin

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months discontinuation of inulin

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months discontinuation of inulin for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Fold change in relative abundance of gut microbiome using using metatranscriptomic analysis from baseline to 3 months after discontinuation of inulin treatment

Fold change in relative abundance of gut microbiome using using metatranscriptomic analysis from baseline to 42 days of inulin treatment

Fold change in relative abundance of gut microbiome using using metatranscriptomic analysis from baseline to 6 months after discontinuation of inulin treatment

+4 more

Secondary study objectives

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

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

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

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Active Control

Group I: Community ControlsActive Control1 Intervention

Community Control subjects will not receive intervention.

Group II: Brain Injury Patients - no interventionActive Control1 Intervention

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

Group III: Brain Injury Patients - inulin interventionActive Control1 Intervention

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

0 / 7Eligibility criteria met