Vibrant capsule treatment for neurogenic bowel in spinal cord injury
Pilot Trial of the Vibrant Capsule for Spinal Cord Injury Neurogenic Bowel Dysfunction
This trial will test whether taking the Vibrant capsule is safe and helps bowel control in people with chronic spinal cord injury who have upper motor neuron neurogenic bowel.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT07213986 on ClinicalTrials.gov |
What this trial studies
This single-site interventional study gives the Vibrant capsule to adults with chronic spinal cord injury (SCI)–related upper motor neuron neurogenic bowel to measure safety and bowel outcomes. The Vibrant capsule is already FDA-approved for chronic idiopathic constipation, and this study applies that medication to the SCI population to see if similar benefits occur. Eligible participants have had SCI for more than one year, stable neurologic function for at least six months, and an unchanged bowel program for at least three months; key exclusions include frequent bowel incontinence, certain gastrointestinal disorders, recent GI surgery, or conditions affecting swallowing. Investigators will record bowel frequency, use of bowel interventions (digital stimulation, suppositories, enemas), adverse events, and any changes in bowel-management needs over the study period.
Who should consider this trial
Good fit: Adults with chronic (over one year) spinal cord injury causing upper motor neuron neurogenic bowel, stable neurologic function for at least six months, on a consistent bowel program for three months, having at least one bowel movement every three days, and able to communicate in English and attend the Houston site are ideal candidates.
Not a fit: People with frequent bowel incontinence (more than once per week), known bowel obstruction or significant GI disease, recent bowel surgery, persistent autonomic dysreflexia triggered by bowel care, pregnancy, or swallowing/esophageal disorders are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the Vibrant capsule could reduce constipation symptoms and lower the need for manual stimulation, suppositories, or enemas for people with SCI-related neurogenic bowel.
How similar studies have performed: The Vibrant capsule has shown benefit and is FDA-approved for chronic idiopathic constipation, but its use specifically for SCI-related neurogenic bowel is novel and has limited prior data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Individuals with chronic spinal cord injury (SCI) of more than one year. * Stable neurological level and function of SCI for at least six months. * Consistent bowel program without changes for at least 3 months. * At least one scheduled bowel movement (BM) every three days. * Use of digital stimulation, suppositories, enemas, or mini enemas, as part of the scheduled bowel program. * Use of oral medications as part of the bowel program. Exclusion Criteria: * Bowel incontinence occurring more than once per week. * Non-English-speaking individuals. * History of bowel obstruction, ileus, diverticulitis, or bowel surgery for a disease (appendix removal is ok). * Persistent autonomic dysreflexia (AD) triggered by bowel movements. * Recent changes to spasticity medications within the past month. * History of significant gastrointestinal disorders * History of Zenker's diverticulum * Dysphagia * Esophageal stricture * Eosinophilic esophagitis or achalasia * Pregnancy. * Presence of implanted devices that could be affected by proximity to a direct current magnetic field.
Where this trial is running
Houston, Texas
- TIRR Memorial Hermann — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Argyrios Stampas, MD — The University of Texas Health Science Center, Houston
- Study coordinator: Argyrios Stampas, MD
- Email: argyrios.stampas@uth.tmc.edu
- Phone: 7127975938
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.