GI-Challenge Study for Gastroparesis Patients and Healthy Controls (NCT03896126) | Clinical Trial Compass
TerminatedNot Applicable
GI-Challenge Study for Gastroparesis Patients and Healthy Controls
Stopped: 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.
United States43 participantsStarted 2019-01-01
Plain-language summary
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.
Who can participate
Age range20 Years – 49 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 criteria
✕. Diagnosis of systemic autonomic nerve dysfunction (i.e. POTS, CAN).
✕. Surgical-related gastroparesis
✕. Extrinsic myopathy or neuropathy causing gastroparesis.
✕. Use of narcotic pain medications in the preceding 2 weeks of study enrollment.
What they're measuring
1
Determination of sympathovagal score, a measure of cardiac autonomic activity, following digestive challenges in healthy volunteers using the FDA-approved ANSAR ANX 3.0 Autonomic Nervous System (ANS) Monitoring System.
Timeframe: Single two hour visit
2
Determination of sympathovagal score following digestive challenges in gastroparesis patients using the ANSAR ANX 3.0 ANS Monitoring System and comparison to healthy volunteers.
Timeframe: Single two hour visit
3
Correlation of sympathovagal score, a measure of cardiac autonomic activity, with gastroparesis disease severity.