The Investigators will recruit 35 participants with acute SCI (within 6 weeks of injury) Fasting blood collection and bowel function survey will be conducted 3 times: at baseline \[within 6 weeks of injury\], 6, and 12 months after SCI. Stool will be collected for gut microbiome analysis 3 times.
Stool and fasting blood collection will occur at the rehabilitation hospital (during in-patient stay) and at participants' homes. During the hospital stay, stool will be collected at the bedside by the research team and placed in a Para-pak® vial for sample preservation. Blood will also be collected by the research team. For sample collection at home, a research nurse will travel to participants home to perform blood draws and bing back to the research lab for processing/analysis/storage. The nurse may also collect the stool sample at the same time as the blood draw if available. If not, participants and their caregivers will be provided with a pre-paid/labeled FedEx package containing a stool collection kit (Para-pak® vial). Prior to bowel movement, participants and caregivers will be asked to clean the anal area using the sanitizing wipes; approximately 5-10 mL of stool will be transferred to the Para-pak® vial using the attached spatula in the Para-pak® vial. For participants who conduct their bowel management program in their beds, an additional sterile absorbent pad will be provided to use as a barrier between the bed and the participant to limit contamination. FedEx package containing the stool sample will be shipped to the investigators' lab For each participant, the Investigators will record 1) diet (via 24-hour dietary recalls), 2) physical activity habits (via the rehabilitation therapies survey included in the SCI common data elements \[CDEs\], 3)Leisure Time Physical Activity Questionnaire; 4)depression and anxiety (via Patient Health Questionnaire-9 \[PHQ9\] and the General Anxiety Disorder-7 scale (GAD7),respectively); 5)prescribed medications, including antibiotics (via RedCap platform); 6)use of supplements and bowel routine components, including probiotics and laxatives (via self-report); and 7)any other comorbidities beyond GI dysfunction
Study Type
OBSERVATIONAL
Enrollment
35
The University of Alabama at Birmingahm
Birmingham, Alabama, United States
RECRUITINGNeurological impairment - Injury level by ISNCSCI
Injury level determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam
Time frame: Baseline
Neurological impairment - Injury level by AIS
Injury level determined by American Spinal Injury Association Impairment Scale (AIS). classification.
Time frame: Baseline
Neurological impairment - completeness of injury by ISNCSCI
Completeness of injury determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam
Time frame: Baseline
Neurological impairment - completeness of injury by AIS
Completeness of injury determined by American Spinal Injury Association Impairment Scale (AIS). classification.
Time frame: Baseline
Neurological impairment - Injury level by ISNCSCI
Injury level determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam
Time frame: Month 6
Neurological impairment - Injury level by AIS
Injury level determined by American Spinal Injury Association Impairment Scale (AIS). classification.
Time frame: Month 6
Neurological impairment - completeness of injury by ISNCSCI
Completeness of injury determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam
Time frame: Month 6
Neurological impairment - completeness of injury by AIS
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Completeness of injury determined by American Spinal Injury Association Impairment Scale (AIS). classification.
Time frame: Month 6
Neurological impairment - Injury level by ISNCSCI
Injury level determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam
Time frame: Month 12
Neurological impairment - Injury level by AIS
Injury level determined by American Spinal Injury Association Impairment Scale (AIS). classification.
Time frame: Month 12
Neurological impairment - completeness of injury by ISNCSCI
Completeness of injury determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam
Time frame: Month 12
Neurological impairment - completeness of injury by AIS
Completeness of injury determined by American Spinal Injury Association Impairment Scale (AIS). classification.
Time frame: Month 12
Microbiome composition - Bacterial 16S rRNA sequincing
Bacterial 16S rRNA sequencing will be performed
Time frame: Baseline
Microbiome composition - Bacterial 16S rRNA sequincing
Bacterial 16S rRNA sequencing will be performed
Time frame: Month 1
Microbiome composition - Bacterial 16S rRNA sequincing
Bacterial 16S rRNA sequencing will be performed
Time frame: Month 6
Microbiome composition - Bacterial 16S rRNA sequincing
Bacterial 16S rRNA sequencing will be performed
Time frame: Month 12
Microbiome composition - Metagenomics
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.
Time frame: Baseline
Microbiome composition - Metagenomics
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.
Time frame: Month 1
Microbiome composition - Metagenomics
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.
Time frame: Month 6
Microbiome composition - Metagenomics
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.
Time frame: Month 12
Gut derived metabolites
Blood will be collected and serum extract metabolites will be isolated
Time frame: Baseline
Gut derived metabolites
Blood will be collected and serum extract metabolites will be isolated
Time frame: Month 1
Gut derived metabolites
Blood will be collected and serum extract metabolites will be isolated
Time frame: Month 6
Gut derived metabolites
Blood will be collected and serum extract metabolites will be isolated
Time frame: Month 12
Analysis of metabolic markers to determine metabolic function
Blood will be collected and serum assays for metabolic markers performed
Time frame: Baseline
Analysis of metabolic markers to determine metabolic function
Blood will be collected and serum assays for metabolic markers performed
Time frame: Month 1
Analysis of metabolic markers to determine metabolic function
Blood will be collected and serum assays for metabolic markers performed
Time frame: Month 6
Analysis of metabolic markers to determine metabolic function
Blood will be collected and serum assays for metabolic markers performed
Time frame: Month 12
Analysis of inflammatory markers to determine Inflammatory state
Blood will be collected and serum assays for inflammatory markers performed
Time frame: Baseline
Analysis of inflammatory markers to determine Inflammatory state
Blood will be collected and serum assays for inflammatory markers performed
Time frame: Month 1
Analysis of inflammatory markers to determine Inflammatory state
Blood will be collected and serum assays for inflammatory markers performed
Time frame: Month 6
Analysis of inflammatory markers to determine Inflammatory state
Blood will be collected and serum assays for inflammatory markers performed
Time frame: Month 12
Bowel function - International Bowel Function Basic and Extended Data Set Assessment
International Bowel Function Basic and Extended Data Set assessment will be utilized to assess bowel-related symptoms.
Time frame: Baseline
Bowel function - Bristol Stool Scale
Bristol Stool Scale assessment will be utilized to assess bowel-related symptoms.
Time frame: Baseline
Bowel function - International Bowel Function Basic and Extended Data Set Assessment
International Bowel Function Basic and Extended Data Set assessment will be utilized to assess bowel-related symptoms.
Time frame: Month 1
Bowel function - Bristol Stool Scale
Bristol Stool Scale assessment will be utilized to assess bowel-related symptoms.
Time frame: Month 1
Bowel function - International Bowel Function Basic and Extended Data Set Assessment
International Bowel Function Basic and Extended Data Set assessment will be utilized to assess bowel-related symptoms.
Time frame: Month 6
Bowel function - Bristol Stool Scale
Bristol Stool Scale assessment will be utilized to assess bowel-related symptoms.
Time frame: Month 6
Bowel function - International Bowel Function Basic and Extended Data Set Assessment
International Bowel Function Basic and Extended Data Set assessment will be utilized to assess bowel-related symptoms.
Time frame: Month 12
Bowel function - Bristol Stool Scale
Bristol Stool Scale assessment will be utilized to assess bowel-related symptoms.
Time frame: Month 12
Diet
Participant records 24-hour dietary recalls
Time frame: Baseline
Diet
Participant records 24-hour dietary recalls
Time frame: Month 1
Diet
Participant records 24-hour dietary recalls
Time frame: Month 6
Diet
Participant records 24-hour dietary recalls
Time frame: Month 12
Physical activity - PARA-SCI
Complete PARA-SCI questionnaire to determine physical activity level
Time frame: Baseline
Physical activity - CDEs
Complete rehabilitation therapies survey (CDEs) to determine physical activity level
Time frame: Baseline
Physical activity - PARA-SCI
Complete PARA-SCI questionnaire to determine physical activity level
Time frame: Month 1
Physical activity - CDEs
Complete rehabilitation therapies survey (CDEs) to determine physical activity level
Time frame: Month 1
Physical activity - PARA-SCI
Complete PARA-SCI questionnaire to determine physical activity level
Time frame: Month 6
Physical activity - CDEs
Complete rehabilitation therapies survey (CDEs) to determine physical activity level
Time frame: Month 6
Physical activity - PARA-SCI
Complete PARA-SCI questionnaire to determine physical activity level
Time frame: Month 12
Physical activity - CDEs
Complete rehabilitation therapies survey (CDEs) to determine physical activity level
Time frame: Month 12
Medication List - Medical Record Review
Medical record review of prescribed medications being taken
Time frame: Baseline
Medication List - Self-report
Self-report of prescribed medications being taken
Time frame: Baseline
Medication List - Medical Record Review
Medical record review of prescribed medications being taken
Time frame: Month 1
Medication List - Self-report
Self-report of prescribed medications being taken
Time frame: Month 1
Medication List - Medical Record Review
Medical record review of prescribed medications being taken
Time frame: Month 6
Medication List - Self-report
Self-report of prescribed medications being taken
Time frame: Month 6
Medication List - Medical Record Review
Medical record review of prescribed medications being taken
Time frame: Month 12
Medication List - Self-report
Self-report of prescribed medications being taken
Time frame: Month 12
Supplement usage - Medical Record Review
Medical record review of supplements being taken
Time frame: Baseline
Supplement usage - self-report
Self-report of supplements being taken
Time frame: Baseline
Supplement usage - Medical Record Review
Medical record review of supplements being taken
Time frame: Month 1
Supplement usage - self-report
Self-report of supplements being taken
Time frame: Month 1
Supplement usage - Medical Record Review
Medical record review of supplements being taken
Time frame: Month 6
Supplement usage - self-report
Self-report of supplements being taken
Time frame: Month 6
Supplement usage - Medical Record Review
Medical record review of supplements being taken
Time frame: Month 12
Supplement usage - self-report
Self-report of supplements being taken
Time frame: Month 12
Depression
Complete PHQ9 questionnaires to determine depression level
Time frame: Baseline
Depression
Complete PHQ9 questionnaires to determine depression level
Time frame: Month 1
Depression
Complete PHQ9 questionnaires to determine depression level
Time frame: Month 6
Depression
Complete PHQ9 questionnaires to determine depression level
Time frame: Month 12
Anxiety
Complete GAD7 questionnaire to determine anxiety level
Time frame: Baseline
Anxiety
Complete GAD7 questionnaire to determine anxiety level
Time frame: Month 1
Anxiety
Complete GAD7 questionnaire to determine anxiety level
Time frame: Month 6
Anxiety
Complete GAD7 questionnaire to determine anxiety level
Time frame: Month 12
Comorbidities
Evaluate Medical history (CDEs) for any other comorbidities beyond GI dysfunction
Time frame: Baseline
Comorbidities
Evaluate Medical history (CDEs) for any other comorbidities beyond GI dysfunction
Time frame: Month 1
Comorbidities
Evaluate Medical history (CDEs) for any other comorbidities beyond GI dysfunction
Time frame: Month 6
Comorbidities
Evaluate Medical history (CDEs) for any other comorbidities beyond GI dysfunction
Time frame: Month 12