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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05670288
Other study ID # IRB-300010011
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 15, 2023
Est. completion date February 28, 2027

Study information

Verified date October 2023
Source University of Alabama at Birmingham
Contact Jereme Wilroy, PhD
Phone (205) 934-0355
Email jdwilroy@uab.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date February 28, 2027
Est. primary completion date December 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: 1. 18-65 years of age 2. diagnosis of traumatic SCI at the cervical or thoracic level (C5-T6) 3. classification of A, B (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).

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Gut Microbiome
Observe the changes in microbial community, such as bacteria, in the gut within the first year of spinal cord injury

Locations

Country Name City State
United States The University of Alabama at Birmingahm Birmingham Alabama

Sponsors (1)

Lead Sponsor Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Neurological impairment - Injury level by ISNCSCI Injury level determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam Baseline
Primary Neurological impairment - Injury level by AIS Injury level determined by American Spinal Injury Association Impairment Scale (AIS). classification. Baseline
Primary Neurological impairment - completeness of injury by ISNCSCI Completeness of injury determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam Baseline
Primary Neurological impairment - completeness of injury by AIS Completeness of injury determined by American Spinal Injury Association Impairment Scale (AIS). classification. Baseline
Primary Neurological impairment - Injury level by ISNCSCI Injury level determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam Month 6
Primary Neurological impairment - Injury level by AIS Injury level determined by American Spinal Injury Association Impairment Scale (AIS). classification. Month 6
Primary 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
Primary Neurological impairment - completeness of injury by AIS Completeness of injury determined by American Spinal Injury Association Impairment Scale (AIS). classification. Month 6
Primary Neurological impairment - Injury level by ISNCSCI Injury level determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam Month 12
Primary Neurological impairment - Injury level by AIS Injury level determined by American Spinal Injury Association Impairment Scale (AIS). classification. Month 12
Primary 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
Primary Neurological impairment - completeness of injury by AIS Completeness of injury determined by American Spinal Injury Association Impairment Scale (AIS). classification. Month 12
Primary Microbiome composition - Bacterial 16S rRNA sequincing Bacterial 16S rRNA sequencing will be performed Baseline
Primary Microbiome composition - Bacterial 16S rRNA sequincing Bacterial 16S rRNA sequencing will be performed Month 1
Primary Microbiome composition - Bacterial 16S rRNA sequincing Bacterial 16S rRNA sequencing will be performed Month 6
Primary Microbiome composition - Bacterial 16S rRNA sequincing Bacterial 16S rRNA sequencing will be performed Month 12
Primary 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
Primary 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
Primary 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
Primary 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
Primary Gut derived metabolites Blood will be collected and serum extract metabolites will be isolated Baseline
Primary Gut derived metabolites Blood will be collected and serum extract metabolites will be isolated Month 1
Primary Gut derived metabolites Blood will be collected and serum extract metabolites will be isolated Month 6
Primary Gut derived metabolites Blood will be collected and serum extract metabolites will be isolated Month 12
Primary Analysis of metabolic markers to determine metabolic function Blood will be collected and serum assays for metabolic markers performed Baseline
Primary Analysis of metabolic markers to determine metabolic function Blood will be collected and serum assays for metabolic markers performed Month 1
Primary Analysis of metabolic markers to determine metabolic function Blood will be collected and serum assays for metabolic markers performed Month 6
Primary Analysis of metabolic markers to determine metabolic function Blood will be collected and serum assays for metabolic markers performed Month 12
Primary Analysis of inflammatory markers to determine Inflammatory state Blood will be collected and serum assays for inflammatory markers performed Baseline
Primary Analysis of inflammatory markers to determine Inflammatory state Blood will be collected and serum assays for inflammatory markers performed Month 1
Primary Analysis of inflammatory markers to determine Inflammatory state Blood will be collected and serum assays for inflammatory markers performed Month 6
Primary Analysis of inflammatory markers to determine Inflammatory state Blood will be collected and serum assays for inflammatory markers performed Month 12
Primary 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
Primary Bowel function - Bristol Stool Scale Bristol Stool Scale assessment will be utilized to assess bowel-related symptoms. Baseline
Primary 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
Primary Bowel function - Bristol Stool Scale Bristol Stool Scale assessment will be utilized to assess bowel-related symptoms. Month 1
Primary 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
Primary Bowel function - Bristol Stool Scale Bristol Stool Scale assessment will be utilized to assess bowel-related symptoms. Month 6
Primary 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
Primary Bowel function - Bristol Stool Scale Bristol Stool Scale assessment will be utilized to assess bowel-related symptoms. Month 12
Secondary Diet Participant records 24-hour dietary recalls Baseline
Secondary Diet Participant records 24-hour dietary recalls Month 1
Secondary Diet Participant records 24-hour dietary recalls Month 6
Secondary Diet Participant records 24-hour dietary recalls Month 12
Secondary Physical activity - PARA-SCI Complete PARA-SCI questionnaire to determine physical activity level Baseline
Secondary Physical activity - CDEs Complete rehabilitation therapies survey (CDEs) to determine physical activity level Baseline
Secondary Physical activity - PARA-SCI Complete PARA-SCI questionnaire to determine physical activity level Month 1
Secondary Physical activity - CDEs Complete rehabilitation therapies survey (CDEs) to determine physical activity level Month 1
Secondary Physical activity - PARA-SCI Complete PARA-SCI questionnaire to determine physical activity level Month 6
Secondary Physical activity - CDEs Complete rehabilitation therapies survey (CDEs) to determine physical activity level Month 6
Secondary Physical activity - PARA-SCI Complete PARA-SCI questionnaire to determine physical activity level Month 12
Secondary Physical activity - CDEs Complete rehabilitation therapies survey (CDEs) to determine physical activity level Month 12
Secondary Medication List - Medical Record Review Medical record review of prescribed medications being taken Baseline
Secondary Medication List - Self-report Self-report of prescribed medications being taken Baseline
Secondary Medication List - Medical Record Review Medical record review of prescribed medications being taken Month 1
Secondary Medication List - Self-report Self-report of prescribed medications being taken Month 1
Secondary Medication List - Medical Record Review Medical record review of prescribed medications being taken Month 6
Secondary Medication List - Self-report Self-report of prescribed medications being taken Month 6
Secondary Medication List - Medical Record Review Medical record review of prescribed medications being taken Month 12
Secondary Medication List - Self-report Self-report of prescribed medications being taken Month 12
Secondary Supplement usage - Medical Record Review Medical record review of supplements being taken Baseline
Secondary Supplement usage - self-report Self-report of supplements being taken Baseline
Secondary Supplement usage - Medical Record Review Medical record review of supplements being taken Month 1
Secondary Supplement usage - self-report Self-report of supplements being taken Month 1
Secondary Supplement usage - Medical Record Review Medical record review of supplements being taken Month 6
Secondary Supplement usage - self-report Self-report of supplements being taken Month 6
Secondary Supplement usage - Medical Record Review Medical record review of supplements being taken Month 12
Secondary Supplement usage - self-report Self-report of supplements being taken Month 12
Secondary Depression Complete PHQ9 questionnaires to determine depression level Baseline
Secondary Depression Complete PHQ9 questionnaires to determine depression level Month 1
Secondary Depression Complete PHQ9 questionnaires to determine depression level Month 6
Secondary Depression Complete PHQ9 questionnaires to determine depression level Month 12
Secondary Anxiety Complete GAD7 questionnaire to determine anxiety level Baseline
Secondary Anxiety Complete GAD7 questionnaire to determine anxiety level Month 1
Secondary Anxiety Complete GAD7 questionnaire to determine anxiety level Month 6
Secondary Anxiety Complete GAD7 questionnaire to determine anxiety level Month 12
Secondary Comorbidities Evaluate Medical history (CDEs) for any other comorbidities beyond GI dysfunction Baseline
Secondary Comorbidities Evaluate Medical history (CDEs) for any other comorbidities beyond GI dysfunction Month 1
Secondary Comorbidities Evaluate Medical history (CDEs) for any other comorbidities beyond GI dysfunction Month 6
Secondary Comorbidities Evaluate Medical history (CDEs) for any other comorbidities beyond GI dysfunction Month 12
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