Gut Microbiome, Spinal Cord Injuries
Conditions
Keywords
SCI, Inflammation, Bowel Function, Blood Sugar, Lipid Profiles
Brief summary
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.
Detailed description
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
Interventions
None listed
Sponsors
University of Pittsburgh Medical Center
Craig Hospital
Rancho Los Amigos National Rehabilitation Center
University of Alabama at Birmingham
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. 18-85 years of age 2. diagnosis of traumatic SCI at the cervical to lumbar level (C3-L2) 3. classification of A, B, C (motor complete, incomplete).
Exclusion criteria
1. Women who are pregnant prior to consent 2. neurological impairment other than SCI 3. self-reported history of Crohn's disease or diverticulitis 4. irritable bowel syndrome 5. gastric blockage/obstruction or swallowing disorder 6. prior GI surgery 7. intrathecal pump 8. concurrent usage of functional electrical stimulation for bowel management (e.g., constipation). 9. able to ambulate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bowel function - Bristol Stool Scale | Baseline | Bristol Stool Scale assessment will be utilized to assess bowel-related symptoms. |
| Gut derived metabolites | Baseline | Blood will be collected and serum extract metabolites will be isolated |
| Neurological impairment - Injury level by ISNCSCI | Baseline | Injury level determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam |
| Neurological impairment - Injury level by AIS | Baseline | Injury level determined by American Spinal Injury Association Impairment Scale (AIS). classification. |
| Neurological impairment - completeness of injury by ISNCSCI | Baseline | Completeness of injury determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam |
| Neurological impairment - completeness of injury by AIS | Baseline | Completeness of injury determined by American Spinal Injury Association Impairment Scale (AIS). classification. |
| Microbiome composition - Bacterial 16S rRNA sequincing | Baseline | Bacterial 16S rRNA sequencing will be performed |
| Microbiome composition - Metagenomics | Baseline | 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. |
| Analysis of metabolic markers to determine metabolic function | Baseline | Blood will be collected and serum assays for metabolic markers performed |
| Analysis of inflammatory markers to determine Inflammatory state | Baseline | Blood will be collected and serum assays for inflammatory markers performed |
| Bowel function - International Bowel Function Basic and Extended Data Set Assessment | Baseline | International Bowel Function Basic and Extended Data Set assessment will be utilized to assess bowel-related symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical activity - PARA-SCI | Baseline | Complete PARA-SCI questionnaire to determine physical activity level |
| Physical activity - CDEs | Baseline | Complete rehabilitation therapies survey (CDEs) to determine physical activity level |
| Medication List - Medical Record Review | Baseline | Medical record review of prescribed medications being taken |
| Medication List - Self-report | Baseline | Self-report of prescribed medications being taken |
| Supplement usage - Medical Record Review | Baseline | Medical record review of supplements being taken |
| Supplement usage - self-report | Baseline | Self-report of supplements being taken |
| Depression | Baseline | Complete PHQ9 questionnaires to determine depression level |
| Anxiety | Baseline | Complete GAD7 questionnaire to determine anxiety level |
| Comorbidities | Baseline | Evaluate Medical history (CDEs) for any other comorbidities beyond GI dysfunction |
| Diet | Baseline | Participant records 24-hour dietary recalls |
Countries
United States
Contacts
Primary ContactJereme Wilroy, PhD
Outcome results
None listed