Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06607523
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-03
Brief Title:
The Gut-Brain Axis During Neurorehabilitation Prebiotic Treatment to Alter the Gut Microbiome and Neurologic Symptoms
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Gut-Brain Axis During Neurorehabilitation Prebiotic Treatment to Alter the Gut Microbiome and Neurologic Symptoms
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
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 eg age sex and clinical factors eg 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
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 eg age sex and clinical factors eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None