Impact of Gut Microbiome on Metabolic and Bowel Function During the First Year After Spinal Cord Injury
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Spinal Cord Injury Patients who have had an acute spinal cord injury in the past 72 hours |
Other: Gut Microbiome
Observe the changes in microbial community, such as bacteria, in the gut within the first year of spinal cord injury
|
Outcome Measures
Primary Outcome Measures
- 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.
- Neurological impairment - Injury level by ISNCSCI [Month 6]
Injury level determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam
- Neurological impairment - Injury level by AIS [Month 6]
Injury level determined by American Spinal Injury Association Impairment Scale (AIS). classification.
- Neurological impairment - completeness of injury by ISNCSCI [Month 6]
Completeness of injury determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam
- Neurological impairment - completeness of injury by AIS [Month 6]
Completeness of injury determined by American Spinal Injury Association Impairment Scale (AIS). classification.
- Neurological impairment - Injury level by ISNCSCI [Month 12]
Injury level determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam
- Neurological impairment - Injury level by AIS [Month 12]
Injury level determined by American Spinal Injury Association Impairment Scale (AIS). classification.
- Neurological impairment - completeness of injury by ISNCSCI [Month 12]
Completeness of injury determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam
- Neurological impairment - completeness of injury by AIS [Month 12]
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 - Bacterial 16S rRNA sequincing [Month 1]
Bacterial 16S rRNA sequencing will be performed
- Microbiome composition - Bacterial 16S rRNA sequincing [Month 6]
Bacterial 16S rRNA sequencing will be performed
- Microbiome composition - Bacterial 16S rRNA sequincing [Month 12]
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.
- Microbiome composition - Metagenomics [Month 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 - Metagenomics [Month 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 - Metagenomics [Month 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 metabolites [Baseline]
Blood will be collected and serum extract metabolites will be isolated
- Gut derived metabolites [Month 1]
Blood will be collected and serum extract metabolites will be isolated
- Gut derived metabolites [Month 6]
Blood will be collected and serum extract metabolites will be isolated
- Gut derived metabolites [Month 12]
Blood will be collected and serum extract metabolites will be isolated
- Analysis of metabolic markers to determine metabolic function [Baseline]
Blood will be collected and serum assays for metabolic markers performed
- Analysis of metabolic markers to determine metabolic function [Month 1]
Blood will be collected and serum assays for metabolic markers performed
- Analysis of metabolic markers to determine metabolic function [Month 6]
Blood will be collected and serum assays for metabolic markers performed
- Analysis of metabolic markers to determine metabolic function [Month 12]
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
- Analysis of inflammatory markers to determine Inflammatory state [Month 1]
Blood will be collected and serum assays for inflammatory markers performed
- Analysis of inflammatory markers to determine Inflammatory state [Month 6]
Blood will be collected and serum assays for inflammatory markers performed
- Analysis of inflammatory markers to determine Inflammatory state [Month 12]
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.
- Bowel function - Bristol Stool Scale [Baseline]
Bristol Stool Scale assessment will be utilized to assess bowel-related symptoms.
- Bowel function - International Bowel Function Basic and Extended Data Set Assessment [Month 1]
International Bowel Function Basic and Extended Data Set assessment will be utilized to assess bowel-related symptoms.
- Bowel function - Bristol Stool Scale [Month 1]
Bristol Stool Scale assessment will be utilized to assess bowel-related symptoms.
- Bowel function - International Bowel Function Basic and Extended Data Set Assessment [Month 6]
International Bowel Function Basic and Extended Data Set assessment will be utilized to assess bowel-related symptoms.
- Bowel function - Bristol Stool Scale [Month 6]
Bristol Stool Scale assessment will be utilized to assess bowel-related symptoms.
- Bowel function - International Bowel Function Basic and Extended Data Set Assessment [Month 12]
International Bowel Function Basic and Extended Data Set assessment will be utilized to assess bowel-related symptoms.
- Bowel function - Bristol Stool Scale [Month 12]
Bristol Stool Scale assessment will be utilized to assess bowel-related symptoms.
Secondary Outcome Measures
- Diet [Baseline]
Participant records 24-hour dietary recalls
- Diet [Month 1]
Participant records 24-hour dietary recalls
- Diet [Month 6]
Participant records 24-hour dietary recalls
- Diet [Month 12]
Participant records 24-hour dietary recalls
- 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
- Physical activity - PARA-SCI [Month 1]
Complete PARA-SCI questionnaire to determine physical activity level
- Physical activity - CDEs [Month 1]
Complete rehabilitation therapies survey (CDEs) to determine physical activity level
- Physical activity - PARA-SCI [Month 6]
Complete PARA-SCI questionnaire to determine physical activity level
- Physical activity - CDEs [Month 6]
Complete rehabilitation therapies survey (CDEs) to determine physical activity level
- Physical activity - PARA-SCI [Month 12]
Complete PARA-SCI questionnaire to determine physical activity level
- Physical activity - CDEs [Month 12]
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
- Medication List - Medical Record Review [Month 1]
Medical record review of prescribed medications being taken
- Medication List - Self-report [Month 1]
Self-report of prescribed medications being taken
- Medication List - Medical Record Review [Month 6]
Medical record review of prescribed medications being taken
- Medication List - Self-report [Month 6]
Self-report of prescribed medications being taken
- Medication List - Medical Record Review [Month 12]
Medical record review of prescribed medications being taken
- Medication List - Self-report [Month 12]
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
- Supplement usage - Medical Record Review [Month 1]
Medical record review of supplements being taken
- Supplement usage - self-report [Month 1]
Self-report of supplements being taken
- Supplement usage - Medical Record Review [Month 6]
Medical record review of supplements being taken
- Supplement usage - self-report [Month 6]
Self-report of supplements being taken
- Supplement usage - Medical Record Review [Month 12]
Medical record review of supplements being taken
- Supplement usage - self-report [Month 12]
Self-report of supplements being taken
- Depression [Baseline]
Complete PHQ9 questionnaires to determine depression level
- Depression [Month 1]
Complete PHQ9 questionnaires to determine depression level
- Depression [Month 6]
Complete PHQ9 questionnaires to determine depression level
- Depression [Month 12]
Complete PHQ9 questionnaires to determine depression level
- Anxiety [Baseline]
Complete GAD7 questionnaire to determine anxiety level
- Anxiety [Month 1]
Complete GAD7 questionnaire to determine anxiety level
- Anxiety [Month 6]
Complete GAD7 questionnaire to determine anxiety level
- Anxiety [Month 12]
Complete GAD7 questionnaire to determine anxiety level
- Comorbidities [Baseline]
Evaluate Medical history (CDEs) for any other comorbidities beyond GI dysfunction
- Comorbidities [Month 1]
Evaluate Medical history (CDEs) for any other comorbidities beyond GI dysfunction
- Comorbidities [Month 6]
Evaluate Medical history (CDEs) for any other comorbidities beyond GI dysfunction
- Comorbidities [Month 12]
Evaluate Medical history (CDEs) for any other comorbidities beyond GI dysfunction
Eligibility Criteria
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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The University of Alabama at Birmingahm | Birmingham | Alabama | United States | 35294 |
Sponsors and Collaborators
- University of Alabama at Birmingham
Investigators
- Principal Investigator: Jereme Wilroy, PhD, University of Alabama at Birmingham
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB-300010011