Vibrant capsule treatment for neurogenic bowel in spinal cord injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.