Ensayos clínicos

Inclusion Criteria:

• Symptoms of chronic nausea or vomiting compatible with gastroparesis (idiopathic or diabetic) must be present for at least one year (does not have to be contiguous) prior to registration.
• Must have a mean total Gastroparesis Cardinal Symptom Index (GCSI) score of ≥ 3 at screening visit.
• Refractory gastroparesis, defined using our previously published data, as a failure to improve over the last 6 months, despite an adequate trial of one or more standard prokinetics (metoclopramide, erythromycin, prucalopride), antinauseants (5-HT3  antagonists, promethazine, prochlorperazine, dronabinol), or neuromodulators (mirtazapine, buspirone).
• Moderate to severe delay in gastric emptying, defined as > 25% solid retained at 4 hours or > 75% retained at 2 hours hours or gastric emptying T half greater than 174 minutes. For inclusion, the qualifying gastric emptying scintigraphy will be the baseline gastric emptying test.
• No evidence of mechanical obstruction based on upper GI endoscopy or upper GI series in their medical history.

Exclusion Criteria:

• Another active disorder which could explain symptoms in the opinion of the investigator
• Gastric retention of solids at 4 hours < 25% or < 75% at 2 hours.
• Ongoing use of prokinetic agents (e.g., metoclopramide, erythromycin, prucalopride) GLP -1 analog or agonists, or drugs that slow down gastric emptying (narcotics). Neuromodulators such as tricyclic antidepressants (amitriptyline or nortriptyline) or others that are being used at stable doses for a month prior to randomization may continue at the discretion of the care provider.
• Significant systemic illness such as chronic renal failure (adjusted for age) or liver disease as defined by Child-Pugh score of 10 or greater.
• Poorly controlled diabetes with HbA1c of greater than 10% at time of screening.
• New medications for gastroparesis-related symptoms started within 1 month prior to registration.
• Pregnancy or nursing.
• Failure to give informed consent.
• Any other condition, which in the opinion of the investigator would impede compliance or hinder completion of the study.
• Botox injection into the pylorus within 3 months prior to registration.
• Allergy to eggs or Egg Beaters and Ensure.

Eligibility last updated 12/5/23. Questions regarding updates should be directed to the study team contact.