GI-Challenge Study for Gastroparesis Patients and Healthy Controls

Launched by STANFORD UNIVERSITY · Mar 27, 2019

Keywords

ClinConnect Summary

The GI-Challenge Study is looking at how the body's nerves respond after eating in people with gastroparesis, a condition that affects how the stomach moves food, compared to healthy individuals. The study aims to understand the function of the vagus nerve, which plays a key role in digestion. By doing this, researchers hope to find out what normal nerve activity looks like and how it can help treat gastroparesis in the future.

To participate, you need to be between 20 and 49 years old and either a healthy volunteer or someone diagnosed with idiopathic gastroparesis. Participants should be stable on their medications for at least four weeks prior to joining. During the study, you will be asked to eat food while your nerve activity is monitored. This is a great opportunity to contribute to important research that could improve treatments for those with gastroparesis. Please note that there are some health conditions and situations that would exclude you from participating, so it’s important to check the full eligibility criteria.

Gender

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Eligibility criteria

• • Inclusion Criteria
• • 1. Male or female.
• • 2. Age 20-49 years old.
• • 3. Healthy volunteer or established diagnosis of idiopathic gastroparesis as per AGA (American Gastroenterology Association) guidelines.
• • 4. Participant is capable of giving informed consent.
• • 5. Gastroparesis patients must be on stable doses of medications for gastroparesis for preceding 4 weeks prior to enrollment (including cholinergics, anti-cholinergics, dopamine and serotonin receptor agonists/antagonists, motility agents, neuromodulators, herbals).
• • Exclusion criteria.
• • 1. Diagnosis of systemic autonomic nerve dysfunction (i.e. POTS, CAN).
• • 2. Surgical-related gastroparesis
• • 3. Extrinsic myopathy or neuropathy causing gastroparesis.
• • 4. Use of narcotic pain medications in the preceding 2 weeks of study enrollment.
• • 5. Patients with enteric feeding tubes or requiring parenteral nutrition.
• • 6. Patients with severe disease flare requiring hospitalization or frequent emergency room visits (last within 3 months or less of enrollment).
• • 7. Untreated significant depression or suicidal thoughts.
• • 8. Pregnant or breast-feeding women.
• • 9. History of gastric pacemaker implantation.
• • 10. Patients with prior gastric surgery, including fundoplication, partial/total gastrectomy, pyloroplasty, or gastric bypass.
• • 11. Patients with implantable electronic devices.
• • 12. Dairy, wheat, or egg allergy/intolerance.
• • 13. Allergy to commercial clinical adhesive for EKG stickers.
• • 14. Non-English speaker and/or hearing impaired (as participants need to follow English verbal commands and cues for the experiment).