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

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.

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Injuries; Gut Microbiome
• Intervention / Treatment: Other: Gut Microbiome

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

• Study Type: Observational
• Enrollment (Estimated): 35

Contacts and Locations

• Study Contact: Name: Jereme Wilroy, PhD; Phone Number: (205) 934-0355; Email: jdwilroy@uab.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Recruiting
      • The University of Alabama at Birmingahm
      • Contact: Jereme Wilroy, PhD; Phone Number: (205) 934-0355; Email: jdwilroy@uab.edu
      • Principal Investigator: Jereme Wilroy, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who have had an acute spinal cord injury in the past 6 weeks.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: University of Pittsburgh Medical Center; Craig Hospital; Rancho Los Amigos National Rehabilitation Center
• Investigators: Principal Investigator: Jereme Wilroy, PhD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: December 8, 2022
• First Submitted That Met QC Criteria: December 20, 2022
• First Posted (Actual): January 4, 2023

Study Record Updates

• Last Update Posted (Estimated): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Inflammation; SCI; Blood Sugar; Lipid Profiles; Bowel Function
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Pathologic Processes; Trauma, Nervous System; Spinal Cord Diseases; Pathological Conditions, Signs and Symptoms; Inflammation; Spinal Cord Injuries
• Other Study ID Numbers: IRB-300010011; 90SIMS0020 (Other Grant/Funding Number: National Institute on Disability, Independent Living, and Rehabilitation Research)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No