Recruiting

Observational Study

Sponsor:

University of Alabama at Birmingham

Code:

NCT05670288

Conditions

Spinal Cord Injuries

Gut Microbiome

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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

Spinal Cord Injuries

Gut Microbiome

Study ID

NCT05670288

Start date

Oct 15, 2023

Status verified date

Dec, 2025

Completion date

Feb 28, 2027

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

35 participants

Anticipated

Interventions and Outcome Measures

Arms

Spinal Cord Injury

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

Primary outcome measure

  • Neurological impairment - Injury level by ISNCSCI [ Time Frame: Baseline ]
  • Neurological impairment - Injury level by AIS [ Time Frame: Baseline ]
  • Neurological impairment - completeness of injury by ISNCSCI [ Time Frame: Baseline ]
  • Neurological impairment - completeness of injury by AIS [ Time Frame: Baseline ]
  • Neurological impairment - Injury level by ISNCSCI [ Time Frame: Month 6 ]
  • Neurological impairment - Injury level by AIS [ Time Frame: Month 6 ]
  • Neurological impairment - completeness of injury by ISNCSCI [ Time Frame: Month 6 ]
  • Neurological impairment - completeness of injury by AIS [ Time Frame: Month 6 ]
  • Neurological impairment - Injury level by ISNCSCI [ Time Frame: Month 12 ]
  • Neurological impairment - Injury level by AIS [ Time Frame: Month 12 ]
  • Neurological impairment - completeness of injury by ISNCSCI [ Time Frame: Month 12 ]
  • Neurological impairment - completeness of injury by AIS [ Time Frame: Month 12 ]
  • Microbiome composition - Bacterial 16S rRNA sequincing [ Time Frame: Baseline ]
  • Microbiome composition - Bacterial 16S rRNA sequincing [ Time Frame: Month 1 ]
  • Microbiome composition - Bacterial 16S rRNA sequincing [ Time Frame: Month 6 ]
  • Microbiome composition - Bacterial 16S rRNA sequincing [ Time Frame: Month 12 ]
  • Microbiome composition - Metagenomics [ Time Frame: Baseline ]
  • Microbiome composition - Metagenomics [ Time Frame: Month 1 ]
  • Microbiome composition - Metagenomics [ Time Frame: Month 6 ]
  • Microbiome composition - Metagenomics [ Time Frame: Month 12 ]
  • Gut derived metabolites [ Time Frame: Baseline ]
  • Gut derived metabolites [ Time Frame: Month 1 ]
  • Gut derived metabolites [ Time Frame: Month 6 ]
  • Gut derived metabolites [ Time Frame: Month 12 ]
  • Analysis of metabolic markers to determine metabolic function [ Time Frame: Baseline ]
  • Analysis of metabolic markers to determine metabolic function [ Time Frame: Month 1 ]
  • Analysis of metabolic markers to determine metabolic function [ Time Frame: Month 6 ]
  • Analysis of metabolic markers to determine metabolic function [ Time Frame: Month 12 ]
  • Analysis of inflammatory markers to determine Inflammatory state [ Time Frame: Baseline ]
  • Analysis of inflammatory markers to determine Inflammatory state [ Time Frame: Month 1 ]
  • Analysis of inflammatory markers to determine Inflammatory state [ Time Frame: Month 6 ]
  • Analysis of inflammatory markers to determine Inflammatory state [ Time Frame: Month 12 ]
  • Bowel function - International Bowel Function Basic and Extended Data Set Assessment [ Time Frame: Baseline ]
  • Bowel function - Bristol Stool Scale [ Time Frame: Baseline ]
  • Bowel function - International Bowel Function Basic and Extended Data Set Assessment [ Time Frame: Month 1 ]
  • Bowel function - Bristol Stool Scale [ Time Frame: Month 1 ]
  • Bowel function - International Bowel Function Basic and Extended Data Set Assessment [ Time Frame: Month 6 ]
  • Bowel function - Bristol Stool Scale [ Time Frame: Month 6 ]
  • Bowel function - International Bowel Function Basic and Extended Data Set Assessment [ Time Frame: Month 12 ]
  • Bowel function - Bristol Stool Scale [ Time Frame: Month 12 ]

Central Contacts and Locations

Central contacts

Jereme Wilroy, PhD

(205) 934-0355jdwilroy@uab.edu

Locations

The University of Alabama at Birmingahm

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Jereme Wilroy, PhD

(205) 934-0355jdwilroy@uab.edu

Principal Investigator:

Jereme Wilroy, PhD

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Dec 17, 2025

Last verified

Dec, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2025-12-17.