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| Name | Class |
|---|---|
| Moody Neurorehabilitation Institute | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inulin | Dietary Supplement | Inulin, 4g twice daily for 42 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Brain Injury Patients
Inclusion
Exclusion
Community Control Subjects
Inclusion
Exclusion
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kate Randolph, BS | Contact | 409-772-8126 | kmrandol@utmb.edu | |
| Christopher Danesi, MS | Contact | 409-772-8126 | cpdanesi@utmb.edu |
| Name | Affiliation | Role |
|---|---|---|
| Randall Urban, MD | University of Texas | Principal Investigator |
| Ana Durand, MD | Moody Neurorehabilitation Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Medical Branch | Recruiting | Galveston | Texas | 77555 | United States |
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| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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| ID | Term |
|---|---|
| D007444 | Inulin |
| ID | Term |
|---|---|
| D013213 | Starch |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 |
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| 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 |
| baseline |
| 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. | 42 days of inulin treatment |
| 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. | 3 months discontinuation of inulin |
| 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. | 6 months discontinuation of inulin |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Macromolecular Substances |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005630 | Fructans |
| D011134 | Polysaccharides |