Prucalopride to help symptoms of diabetic and idiopathic gastroparesis
A multicenter, double-blind, randomized, placebo- controlled, parallel study to assess the efficacy of 5- HT4 agonist prucalopride for the treatment of diabetic and idiopathic gastroparesis
People with diabetic or idiopathic gastroparesis are given prucalopride or a placebo to see if taking prucalopride eases stomach-emptying problems and related symptoms.
Quick facts
| Grant type | U01 cooperative agreement |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Texas Tech University Health Sciences Center at El Paso NIH-funded |
| Lab location | 1 site (El Paso, United States) |
| Project ID | NIH-11158600 on NIH RePORTER |
What this research studies
If I join, I'll be randomly assigned to receive prucalopride or a placebo and neither I nor the study team will know which I get, with the trial running at multiple clinical centers. Participants are enrolled in a gastroparesis registry where clinical information and blood samples, including peripheral blood mononuclear cells (PBMCs), are collected. Some participants may provide stomach or duodenal brushings during endoscopy, and tissue samples if they undergo relevant surgery, while others may have pyloric function measured with EndoFLIP. The project also completes a related Buspirone treatment arm and follows symptoms, side effects, and objective stomach-emptying tests over time.
Who could benefit from this research
Good fit: Adults diagnosed with diabetic or idiopathic gastroparesis who meet the trial's medical criteria and are willing to attend clinic visits, provide blood samples, and undergo endoscopy-related sampling or other tests are ideal candidates.
Not a fit: People whose gastroparesis has a different known cause, who cannot take prucalopride, or who are unable or unwilling to undergo the required procedures may not benefit or be eligible.
Why it matters
Potential benefit: If successful, this could reduce nausea, vomiting, bloating, and delayed stomach emptying for people with diabetic or idiopathic gastroparesis.
How similar studies have performed: Prucalopride is approved for chronic constipation and small studies suggest it may help stomach motility, but large randomized trials in gastroparesis have been limited.
Where this research is happening
El Paso, United States
- Texas Tech University Health Sciences Center at El Paso — El Paso, United States (Active)
Researchers
- Principal investigator: Sarosiek, Irene — Texas Tech University Health Sciences Center at El Paso
- Study coordinator: Sarosiek, Irene
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.