Prucalopride to help symptoms of diabetic and idiopathic gastroparesis
Official title: 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
Funded at Texas Tech University Health Sciences Center at El Paso · NIH-11158600 · Data updated 2026-11-12
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 start | September 30, 2008 |
| Project end | July 31, 2027 |
| Funding year | 2025 |
| Award (this year) | $350,557 |
| NIH project number | 5U01DK074035-16 |
| Project ID | NIH-11158600 on NIH RePORTER |
Who could benefit from this research
✓Could help
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.
✕Less likely to help
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.
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.
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 gone: 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
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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
Related research
Other NIH-funded projects on the same topics.
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New England Gastroparesis Consortium: Neurobiology of Gastroparesis
A national project to learn about gastroparesis in children and adults by creating a registry and gathering information from patients to understand symptoms, quality of life, and disease progression.
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Pediatric and Young Adult Gastroparesis Registry and Disease Course
This project follows children, teens, and young adults with symptoms of gastroparesis to learn how their symptoms change over time and what factors are tied to different disease patterns.
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Pediatric gastroparesis: building a nationwide patient registry
This grant funds a national registry to study gastroparesis and similar tummy problems in children and teens, with the goal of better understanding how the condition affects their daily lives.
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Gut-resident macrophages and gastric function in gastroparesis
A study in people with gastroparesis to understand how gut macrophages affect stomach movement and gut barrier health, with the hope of finding new ways to treat the condition.
-
Gastric electrical stimulation for stomach pain in gastroparesis
A new approach tests how adjusting a stomach-stimulating implant may reduce pain for people with gastroparesis.
-
Peptide therapies for gastroparesis in diabetes
A new peptide-based treatment is being tested to help people with gastroparesis linked to diabetes by improving stomach emptying and reducing inflammation.
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.