Observational Study on Gut Microbiome After Spinal Cord Injury
This study is looking at how the gut microbiome (the community of bacteria in your intestines) changes during the first year after a spinal cord injury (SCI). Researchers want to understand if these changes are linked to metabolic (how your body uses energy) and bowel function. They will observe 35 people who have had a recent traumatic SCI (within 6 weeks of injury) affecting their neck or back (C3-L2 level). You could be eligible if you are between 18 and 85 years old and have a specific type of SCI. The study will involve collecting blood and stool samples, and asking about bowel function, at three different times over one year. The goal is to learn more about the connection between your gut health and recovery after SCI.
- Study design
- This is an observational study involving 35 participants. It is not testing a specific intervention or drug.
- What's involved
- You would have blood and stool samples collected, and complete a bowel function survey, at baseline (within 6 weeks of injury), 6 months, and 12 months after your SCI.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 12 months after their spinal cord injury.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Impact of Gut Microbiome on Metabolic and Bowel Function During the First Year After Spinal Cord Injury
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Jereme Wilroy, PhD · PRINCIPAL_INVESTIGATOR · University of Alabama at Birmingham
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Neurological impairment - Injury level by ISNCSCIBaseline
Injury level determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam
- Neurological impairment - Injury level by AISBaseline
Injury level determined by American Spinal Injury Association Impairment Scale (AIS). classification.
- Neurological impairment - completeness of injury by ISNCSCIBaseline
Completeness of injury determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam
- Neurological impairment - completeness of injury by AISBaseline
Completeness of injury determined by American Spinal Injury Association Impairment Scale (AIS). classification.
- Neurological impairment - Injury level by ISNCSCIMonth 6
Injury level determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam
- Neurological impairment - Injury level by AISMonth 6
Injury level determined by American Spinal Injury Association Impairment Scale (AIS). classification.
- Neurological impairment - completeness of injury by ISNCSCIMonth 6
Completeness of injury determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam
- Neurological impairment - completeness of injury by AISMonth 6
Completeness of injury determined by American Spinal Injury Association Impairment Scale (AIS). classification.
- Neurological impairment - Injury level by ISNCSCIMonth 12
Injury level determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam
- Neurological impairment - Injury level by AISMonth 12
Injury level determined by American Spinal Injury Association Impairment Scale (AIS). classification.
- Neurological impairment - completeness of injury by ISNCSCIMonth 12
Completeness of injury determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam
- Neurological impairment - completeness of injury by AISMonth 12
Completeness of injury determined by American Spinal Injury Association Impairment Scale (AIS). classification.
- Microbiome composition - Bacterial 16S rRNA sequincingBaseline
Bacterial 16S rRNA sequencing will be performed
- Microbiome composition - Bacterial 16S rRNA sequincingMonth 1
Bacterial 16S rRNA sequencing will be performed
- Microbiome composition - Bacterial 16S rRNA sequincingMonth 6
Bacterial 16S rRNA sequencing will be performed
- Microbiome composition - Bacterial 16S rRNA sequincingMonth 12
Bacterial 16S rRNA sequencing will be performed
- Microbiome composition - MetagenomicsBaseline
A subset of 16S rRNA gene surveys that show differences in taxa and alpha and beta diversity are selected for follow-up via shotgun metagenomics.
- Microbiome composition - MetagenomicsMonth 1
A subset of 16S rRNA gene surveys that show differences in taxa and alpha and beta diversity are selected for follow-up via shotgun metagenomics.
- Microbiome composition - MetagenomicsMonth 6
A subset of 16S rRNA gene surveys that show differences in taxa and alpha and beta diversity are selected for follow-up via shotgun metagenomics.
- Microbiome composition - MetagenomicsMonth 12
A subset of 16S rRNA gene surveys that show differences in taxa and alpha and beta diversity are selected for follow-up via shotgun metagenomics.
- Gut derived metabolitesBaseline
Blood will be collected and serum extract metabolites will be isolated
- Gut derived metabolitesMonth 1
Blood will be collected and serum extract metabolites will be isolated
- Gut derived metabolitesMonth 6
Blood will be collected and serum extract metabolites will be isolated
- Gut derived metabolitesMonth 12
Blood will be collected and serum extract metabolites will be isolated
- Analysis of metabolic markers to determine metabolic functionBaseline
Blood will be collected and serum assays for metabolic markers performed
- Analysis of metabolic markers to determine metabolic functionMonth 1
Blood will be collected and serum assays for metabolic markers performed
- Analysis of metabolic markers to determine metabolic functionMonth 6
Blood will be collected and serum assays for metabolic markers performed
- Analysis of metabolic markers to determine metabolic functionMonth 12
Blood will be collected and serum assays for metabolic markers performed
- Analysis of inflammatory markers to determine Inflammatory stateBaseline
Blood will be collected and serum assays for inflammatory markers performed
- Analysis of inflammatory markers to determine Inflammatory stateMonth 1
Blood will be collected and serum assays for inflammatory markers performed
- Analysis of inflammatory markers to determine Inflammatory stateMonth 6
Blood will be collected and serum assays for inflammatory markers performed
- Analysis of inflammatory markers to determine Inflammatory stateMonth 12
Blood will be collected and serum assays for inflammatory markers performed
- Bowel function - International Bowel Function Basic and Extended Data Set AssessmentBaseline
International Bowel Function Basic and Extended Data Set assessment will be utilized to assess bowel-related symptoms.
- Bowel function - Bristol Stool ScaleBaseline
Bristol Stool Scale assessment will be utilized to assess bowel-related symptoms.
- Bowel function - International Bowel Function Basic and Extended Data Set AssessmentMonth 1
International Bowel Function Basic and Extended Data Set assessment will be utilized to assess bowel-related symptoms.
- Bowel function - Bristol Stool ScaleMonth 1
Bristol Stool Scale assessment will be utilized to assess bowel-related symptoms.
- Bowel function - International Bowel Function Basic and Extended Data Set AssessmentMonth 6
International Bowel Function Basic and Extended Data Set assessment will be utilized to assess bowel-related symptoms.
- Bowel function - Bristol Stool ScaleMonth 6
Bristol Stool Scale assessment will be utilized to assess bowel-related symptoms.
- Bowel function - International Bowel Function Basic and Extended Data Set AssessmentMonth 12
International Bowel Function Basic and Extended Data Set assessment will be utilized to assess bowel-related symptoms.
- Bowel function - Bristol Stool ScaleMonth 12
Bristol Stool Scale assessment will be utilized to assess bowel-related symptoms.