GI-Challenge Study for Gastroparesis Patients and Healthy Controls
Reason given: Study was stopped due to technical issues with the ANSAR equipment, lack of research personnel caused by COVID-19 restrictions imposed at our site, and recent departure of the PI and study chair from our research institute.
Key facts
- Where
- Palo Alto, United StatesSee the site
Where in United States
- Stanford University Medical CenterPalo Alto, United StatesNo longer taking part
Trial details
- Who runs it
- Stanford University
- Trial code
- NCT03896126
- Record updated
- 4 September 2025
- Original description
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.Read full original descriptionShow less
Instantaneous Measures of Autonomic Nervous System Responses to Gastrointestinal Challenges
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.
Inclusion: Male or female; Age 20-49 years old; Healthy volunteer or established diagnosis of idiopathic gastroparesis as per AGA (American Gastroenterology Association) guidelines; Participant is capable of giving informed consent; 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: Surgical-related gastroparesis; Use of narcotic pain medications in the preceding 2 weeks of study enrollment; Patients with prior gastric surgery, including fundoplication, partial/total gastrectomy, pyloroplasty, or gastric bypass; Patients with severe disease flare requiring hospitalization or frequent emergency room visits (last within 3 months or less of enrollment); History of gastric pacemaker implantation; Dairy, wheat, or egg allergy/intolerance; Allergy to commercial clinical adhesive for EKG stickers; Diagnosis of systemic autonomic nerve dysfunction (i.e. POTS, CAN); Extrinsic myopathy or neuropathy causing gastroparesis; Patients with enteric feeding tubes or requiring parenteral nutrition; Untreated significant depression or suicidal thoughts; Pregnant or breast-feeding women; Patients with implantable electronic devices; Non-English speaker and/or hearing impaired (as participants need to follow English verbal commands and cues for the experiment).