Impact of Gut Microbiome on Metabolic and Bowel Function During the First Year After Spinal Cord Injury

Study Overview
=================
Brief Summary
-----------------
The Investigators will recruit 50 participants with acute SCI (within 72 hours of injury) Fasting blood collection and bowel function survey will be conducted 4 times: at baseline [the time of first stool sample, within 72 hours of injury] and 1, 6, and 12 months after SCI. Stool will be collected for gut microbiome analysis 4 times

Detailed Description
-----------------
Stool and fasting blood collection will occur at the 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 and Twilio platform); 6)use of supplements and bowel routine components, including probiotics and laxatives (via self-report); and 7)any other comorbidities beyond GI dysfunction

Official Title
-----------------
Impact of Gut Microbiome on Metabolic and Bowel Function During the First Year After Spinal Cord Injury

Conditions
-----------------
Spinal Cord Injuries, Gut Microbiome

Intervention / Treatment
-----------------
* Other: Gut Microbiome


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-65 years of age diagnosis of traumatic SCI at the cervical or thoracic level (C5-T6) classification of A, B (motor complete, incomplete). Exclusion Criteria: Women who are pregnant prior to consent neurological impairment other than SCI self-reported history of Crohn's disease or diverticulitis irritable bowel syndrome gastric blockage/obstruction or swallowing disorder prior GI surgery intrathecal pump concurrent usage of functional electrical stimulation for bowel management (e.g., constipation).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Spinal Cord Injury<br>Patients who have had an acute spinal cord injury in the past 72 hours | Other: Gut Microbiome<br>* Observe the changes in microbial community, such as bacteria, in the gut within the first year of spinal cord injury<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurological impairment - Injury level by ISNCSCI | Injury level determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam | Baseline | 
| Neurological impairment - Injury level by AIS | Injury level determined by American Spinal Injury Association Impairment Scale (AIS). classification. | Baseline | 
| Neurological impairment - completeness of injury by ISNCSCI | Completeness of injury determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam | Baseline | 
| Neurological impairment - completeness of injury by AIS | Completeness of injury determined by American Spinal Injury Association Impairment Scale (AIS). classification. | Baseline | 
| Neurological impairment - Injury level by ISNCSCI | Injury level determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam | Month 6 | 
| Neurological impairment - Injury level by AIS | Injury level determined by American Spinal Injury Association Impairment Scale (AIS). classification. | 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 | Month 6 | 
| Neurological impairment - completeness of injury by AIS | Completeness of injury determined by American Spinal Injury Association Impairment Scale (AIS). classification. | Month 6 | 
| Neurological impairment - Injury level by ISNCSCI | Injury level determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam | Month 12 | 
| Neurological impairment - Injury level by AIS | Injury level determined by American Spinal Injury Association Impairment Scale (AIS). classification. | 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 | Month 12 | 
| Neurological impairment - completeness of injury by AIS | Completeness of injury determined by American Spinal Injury Association Impairment Scale (AIS). classification. | Month 12 | 
| Microbiome composition - Bacterial 16S rRNA sequincing | Bacterial 16S rRNA sequencing will be performed | Baseline | 
| Microbiome composition - Bacterial 16S rRNA sequincing | Bacterial 16S rRNA sequencing will be performed | Month 1 | 
| Microbiome composition - Bacterial 16S rRNA sequincing | Bacterial 16S rRNA sequencing will be performed | Month 6 | 
| Microbiome composition - Bacterial 16S rRNA sequincing | Bacterial 16S rRNA sequencing will be performed | 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. | 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. | 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. | 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. | Month 12 | 
| Gut derived metabolites | Blood will be collected and serum extract metabolites will be isolated | Baseline | 
| Gut derived metabolites | Blood will be collected and serum extract metabolites will be isolated | Month 1 | 
| Gut derived metabolites | Blood will be collected and serum extract metabolites will be isolated | Month 6 | 
| Gut derived metabolites | Blood will be collected and serum extract metabolites will be isolated | Month 12 | 
| Analysis of metabolic markers to determine metabolic function | Blood will be collected and serum assays for metabolic markers performed | Baseline | 
| Analysis of metabolic markers to determine metabolic function | Blood will be collected and serum assays for metabolic markers performed | Month 1 | 
| Analysis of metabolic markers to determine metabolic function | Blood will be collected and serum assays for metabolic markers performed | Month 6 | 
| Analysis of metabolic markers to determine metabolic function | Blood will be collected and serum assays for metabolic markers performed | Month 12 | 
| Analysis of inflammatory markers to determine Inflammatory state | Blood will be collected and serum assays for inflammatory markers performed | Baseline | 
| Analysis of inflammatory markers to determine Inflammatory state | Blood will be collected and serum assays for inflammatory markers performed | Month 1 | 
| Analysis of inflammatory markers to determine Inflammatory state | Blood will be collected and serum assays for inflammatory markers performed | Month 6 | 
| Analysis of inflammatory markers to determine Inflammatory state | Blood will be collected and serum assays for inflammatory markers performed | 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. | Baseline | 
| Bowel function - Bristol Stool Scale | Bristol Stool Scale assessment will be utilized to assess bowel-related symptoms. | 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. | Month 1 | 
| Bowel function - Bristol Stool Scale | Bristol Stool Scale assessment will be utilized to assess bowel-related symptoms. | 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. | Month 6 | 
| Bowel function - Bristol Stool Scale | Bristol Stool Scale assessment will be utilized to assess bowel-related symptoms. | 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. | Month 12 | 
| Bowel function - Bristol Stool Scale | Bristol Stool Scale assessment will be utilized to assess bowel-related symptoms. | Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diet | Participant records 24-hour dietary recalls | Baseline | 
| Diet | Participant records 24-hour dietary recalls | Month 1 | 
| Diet | Participant records 24-hour dietary recalls | Month 6 | 
| Diet | Participant records 24-hour dietary recalls | Month 12 | 
| Physical activity - PARA-SCI | Complete PARA-SCI questionnaire to determine physical activity level | Baseline | 
| Physical activity - CDEs | Complete rehabilitation therapies survey (CDEs) to determine physical activity level | Baseline | 
| Physical activity - PARA-SCI | Complete PARA-SCI questionnaire to determine physical activity level | Month 1 | 
| Physical activity - CDEs | Complete rehabilitation therapies survey (CDEs) to determine physical activity level | Month 1 | 
| Physical activity - PARA-SCI | Complete PARA-SCI questionnaire to determine physical activity level | Month 6 | 
| Physical activity - CDEs | Complete rehabilitation therapies survey (CDEs) to determine physical activity level | Month 6 | 
| Physical activity - PARA-SCI | Complete PARA-SCI questionnaire to determine physical activity level | Month 12 | 
| Physical activity - CDEs | Complete rehabilitation therapies survey (CDEs) to determine physical activity level | Month 12 | 
| Medication List - Medical Record Review | Medical record review of prescribed medications being taken | Baseline | 
| Medication List - Self-report | Self-report of prescribed medications being taken | Baseline | 
| Medication List - Medical Record Review | Medical record review of prescribed medications being taken | Month 1 | 
| Medication List - Self-report | Self-report of prescribed medications being taken | Month 1 | 
| Medication List - Medical Record Review | Medical record review of prescribed medications being taken | Month 6 | 
| Medication List - Self-report | Self-report of prescribed medications being taken | Month 6 | 
| Medication List - Medical Record Review | Medical record review of prescribed medications being taken | Month 12 | 
| Medication List - Self-report | Self-report of prescribed medications being taken | Month 12 | 
| Supplement usage - Medical Record Review | Medical record review of supplements being taken | Baseline | 
| Supplement usage - self-report | Self-report of supplements being taken | Baseline | 
| Supplement usage - Medical Record Review | Medical record review of supplements being taken | Month 1 | 
| Supplement usage - self-report | Self-report of supplements being taken | Month 1 | 
| Supplement usage - Medical Record Review | Medical record review of supplements being taken | Month 6 | 
| Supplement usage - self-report | Self-report of supplements being taken | Month 6 | 
| Supplement usage - Medical Record Review | Medical record review of supplements being taken | Month 12 | 
| Supplement usage - self-report | Self-report of supplements being taken | Month 12 | 
| Depression | Complete PHQ9 questionnaires to determine depression level | Baseline | 
| Depression | Complete PHQ9 questionnaires to determine depression level | Month 1 | 
| Depression | Complete PHQ9 questionnaires to determine depression level | Month 6 | 
| Depression | Complete PHQ9 questionnaires to determine depression level | Month 12 | 
| Anxiety | Complete GAD7 questionnaire to determine anxiety level | Baseline | 
| Anxiety | Complete GAD7 questionnaire to determine anxiety level | Month 1 | 
| Anxiety | Complete GAD7 questionnaire to determine anxiety level | Month 6 | 
| Anxiety | Complete GAD7 questionnaire to determine anxiety level | Month 12 | 
| Comorbidities | Evaluate Medical history (CDEs) for any other comorbidities beyond GI dysfunction | Baseline | 
| Comorbidities | Evaluate Medical history (CDEs) for any other comorbidities beyond GI dysfunction | Month 1 | 
| Comorbidities | Evaluate Medical history (CDEs) for any other comorbidities beyond GI dysfunction | Month 6 | 
| Comorbidities | Evaluate Medical history (CDEs) for any other comorbidities beyond GI dysfunction | Month 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SCI, Inflammation, Bowel Function, Blood Sugar, Lipid Profiles