Examining the gut microbiome's effects on metabolic and bowel function after spinal cord injury
Official title: Impact of Gut Microbiome on Metabolic and Bowel Function During the First Year After Spinal Cord Injury
Run by University of Alabama at Birmingham · NCT05670288 · Data updated 2026-11-12
This study is trying to see how the gut bacteria of people with a recent spinal cord injury affects their metabolism and bowel function over the first year after the injury.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 35 (estimated) |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Status | Recruiting |
| Started | October 15, 2023 |
| Main results expected | December 1, 2026 |
| Study ends | February 28, 2027 |
| Registry record updated | December 17, 2025 |
| Trial ID | NCT05670288 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-85 who have sustained a traumatic spinal cord injury at the cervical to lumbar level.
✕Probably not a fit
Patients with neurological impairments other than SCI or those with specific gastrointestinal disorders may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to recruit 35 participants who have experienced an acute spinal cord injury (SCI) within the last six weeks. Participants will undergo fasting blood collection and bowel function surveys at three time points: baseline, 6 months, and 12 months post-injury. Stool samples will also be collected for gut microbiome analysis during these visits, which will occur both in the rehabilitation hospital and at participants' homes. A research nurse will assist with sample collection and provide necessary materials for home collection.
Why it matters
Potential benefit: If successful, this study could enhance understanding of how gut microbiome influences metabolic and bowel function in individuals with spinal cord injuries.
How similar studies have gone: While there is ongoing research into the gut microbiome's role in various conditions, this specific focus on spinal cord injury and its metabolic implications is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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The University of Alabama at Birmingahm
Birmingham, Alabama, United States Recruiting
Study contacts
- Principal investigator: Jereme Wilroy, PhD — University of Alabama at Birmingham
- Study coordinator: Jereme Wilroy, PhD
- Email: jdwilroy@uab.edu
- Phone: (205) 934-0355
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.