Ensayos clínicos

Inclusion Criteria:

• Patients with gastroparesis or functional dyspepsia
• Age 18-70 years
• Patients will be identified from among Mayo Clinic patients.
• Patients will have symptoms consistent with gastroparesis based on a national guideline for gastroparesis (symptoms PLUS delayed gastric emptying of solids).
• Patients with Rome IV criteria for postprandial distress syndrome (a subset of functional dyspepsia) will be selected based on gastric emptying of solids which is NOT delayed, in addition to standard FD criteria:
  • Symptoms fulfilled for the last 3 months with onset greater than 6 months before diagnosis;
  • One or more symptoms being bothersome: postprandial fullness, early satiation, epigastric pain or burning;
  • Must include one or both of the following at least 3 days per week: bothersome postprandial fullness (i.e., severe enough to impact on usual activities) or bothersome early satiation (i.e., severe enough to prevent finishing a regular-size meal);
  • No evidence of organic, systemic, or metabolic disease to explain the symptoms on routine investigations;
  • Participants will have previously undergone test of gastric emptying of solids using the standardized Mayo Clinic scintigraphic method
• Ability to provide informed consent
• Absence of other diseases (structural or metabolic) which could interfere with interpretation of the study results
• Body mass index of 18-35 kg/m2
• Several medication classes, particularly those affecting gastrointestinal transit or motor functions, will be excluded, including GLP-1 receptor or amylin agonists in patients with diabetes mellitus. Stable doses of thyroid replacement, estrogen replacement, low-dose aspirin for cardioprotection, and birth control (but with adequate backup contraception, as drug interactions with birth control have not been conducted for secretin PAM) are permissible.

Exclusion Criteria:

• Patients with current H. pylori infection will be excluded.
• Pregnancy or lactation.
• Rapid metabolizers for CYP3A4 or CYP2C19 [estimated prevalence of 17% and 18% respectively based on literature review (36)] will be excluded since this could impact assessment of effects of cannabidiol.
• Patients with abnormal baseline liver transaminases (any value above UNL), since up to 3-fold, dose-related elevations of liver transaminases (ALT and/or AST) occur in 13% of treated patients (vs. 1% placebo).
• Hypersensitivity to cannabidiol or any of the ingredients in EPIDIOLEX.
• Concomitant use of valproate, CNS depressants and alcohol, other hepatotoxic drugs.
• The subject has HbA1c > 12%
• The subject is unable to withdraw any of the following medications listed in table 1a 48 hours prior to the study
• The subject has participated in another interventional clinical study within the past two weeks.
• History of recent surgery (within 60 days of screening)
• The subject has a history diagnosis of post-surgical gastroparesis
• A subject who in the determination of the investigator, possesses any condition that the investigator believes would put the subject at risk or would preclude the subject from successfully completing all aspects of the study.
• Concomitant use of CNS depressants and/or alcohol within 48 hours of GI testing, unless able to maintain a consistent dosage throughout the study.

Eligibility last updated 6/3/22. Questions regarding updates should be directed to the study team contact.