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

NCT05670288 | Recruiting

• 2 other identifiers: IRB-30001001190SIMS0020
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Gut Microbiome; Spinal Cord Injuries

Keywords

SCI; Inflammation; Bowel Function; Blood Sugar; Lipid Profiles

Outcome Measures

Primary Outcomes (40)

• 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 Outcomes (40)

• Diet

  Baseline

• Diet

  Month 1

• Diet

  Month 6

• Diet

  Month 12

• Physical activity - PARA-SCI

  Baseline

Study Arms (1)

Spinal Cord Injury

Patients who have had an acute spinal cord injury in the past 72 hours

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• years of age
• diagnosis of traumatic SCI at the cervical to lumbar level (C3-L2)
• classification of A, B, C (motor complete, incomplete).

You may not qualify if:

• 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).
• able to ambulate

Sponsors & Collaborators

• Rancho Los Amigos National Rehabilitation Center: collaborator
• University of Alabama at Birmingham: lead
• University of Pittsburgh Medical Center: collaborator
• Craig Hospital: collaborator

Study Sites (1)

The University of Alabama at Birmingahm

Birmingham, Alabama, 35294, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Stool and Blood

MeSH Terms

Conditions

Spinal Cord Injuries; Inflammation

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jereme Wilroy, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jereme Wilroy, PhD

CONTACT

(205) 934-0355; jdwilroy@uab.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: January 4, 2023
• Study Start: October 15, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)