Clinical Trials

Inclusion Criteria:

• Adults (M/F/other) between the ages of 22-80 years of age.
• High probability of compliance and completion of study.
• Fulfilling one or more of the following criteria:
  • Received a delayed gastric emptying result from a gastric emptying study (gastric scintigraphy [GES] or gastric emptying breath test [GEBT] or SmartPill) in the last two years AND/OR presenting with 2 or more of the following symptoms or signs:
  • Nausea, vomiting, or retching (dry heaves);
  • Postprandial fullness or early satiety;
  • Bloating or visible abdominal distention;
  • Postprandial discomfort or pain AND/OR;
  • Suffering from symptoms of chronic idiopathic constipation based on ROME IV criteria (exclusion of constipation caused by structural abnormalities), participant should have at least 1 bowel motion per week (either assisted or unassisted by medication) AND/OR;
  • Suffering from symptoms of IBS-C based on ROME IV criteria.
• Participant or their legally authorized representative has the ability to provide informed consent and comply with the protocol.

Exclusion Criteria:

• Recent abdominal and/or pelvic surgery (past 3 months).
• Acute diverticulitis, confirmed by CT scan in past 3 months, diverticular stricture, and other intestinal strictures.
• Chronic daily use of nonsteroidal anti-inflammatory drugs (e.g., ibuprofen, naproxen).
• Pregnant or breastfeeding.
• Patients on long-acting glucagon-like peptide (GLP-1).
• Active implantable devices (e.g., gastric stimulator, pacemaker, defibrillator) [continuous glucose monitors are permitted].
• Evidence of metabolic disease within the last six months (overt hypothyroidism [high TSH, low FT4], uncontrolled diabetes [hemoglobin A1c >10%] within the past 6 months) not stabilized within the past 3 months via constant medication (dosage and type must be consistent) usage.
• History of gastric bezoar formation.
• Presence of fistulas or other mechanical GI obstruction.
• Radiation enteritis.
• History of fecal impaction.
• Suspicion of other organic GI disease.
• Suspicion of obscure GI bleeding.
• Unable to stop medications that may alter gastric pH (such as proton pump inhibitors) for 7 days prior to and during study.
• Unable to stop medications that may alter GI motility (GLP-1 agonists, anticholinergics, metformin, antispasmodic, prokinetics) for 72 hours prior to and during study.
• Chronic daily use of cannabinoids (e.g., dronabinol, marijuana).
• Unable to stop laxatives (docusate, lactulose, sorbitol, senna, bisacodyl), suppositories (glycerin), and enema 72 hours prior to and during the study. Limited use of rescue laxatives is permissible at the investigators discretion but must be tracked in the electronic case report form (eCRF).
• May require an MRI scan during the duration of this study.
• BMI > 40kg/m^2.
• Allergies to any of the ingredients used in the standardized meal.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 3/1/23. Questions regarding updates should be directed to the study team contact.