GI-Challenge Study for Gastroparesis Patients and Healthy Controls


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Trial ID: NCT03896126


Gastroparesis Patients and Healthy Controls ages 20-49 will be asked to participate in an observational study measuring vagal activity following food ingestion in order to establish parameters of autonomic nerve/vagal function in healthy human subjects compared to those with gastroparesis. Information generated from this study may be used in the future to establish what is normal and abnormal enteric vagal tone and how much vagal nerve stimulation treatment may be required to help patients with gastroparesis.

Official Title

Instantaneous Measures of Autonomic Nervous System Responses to Gastrointestinal Challenges

Stanford Investigator(s)

Linda Nguyen
Linda Nguyen

Clinical Professor, Medicine - Gastroenterology & Hepatology


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).


other: Observational


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Andres Gottfried Blackmore, MD PhD