Examining the gut microbiome's effects on metabolic and bowel function after spinal cord injury
Impact of Gut Microbiome on Metabolic and Bowel Function During the First Year After Spinal Cord Injury
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 |
|---|---|
| Enrollment | 35 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT05670288 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-85 who have sustained a traumatic spinal cord injury at the cervical to lumbar level.
Not a fit: Patients with neurological impairments other than SCI or those with specific gastrointestinal disorders may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Birmingham, Alabama
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.