Clinical Trials

Inclusion Criteria:

• Adult patients, men and women ages 18-75.
• Symptoms of dyspepsia thought to represent Functional Dyspepsia (FD), meeting Rome IV criteria. 
• Had an upper endoscopy and assessment for Helicobacter pylori; if a patient is found to have H. pylori, treatment with confirmed eradication (by stool antigen test or urea breath test) will be required before the patient is eligible for study inclusion.
• Patients will be considered for the study if they have undergone a complete history and physical examination during a previously scheduled consultation/evaluation visit with a gastroenterologist in the Mayo Clinic Florida General GI or Motility clinic. 
• If a patient is interested in study participation, and if all inclusion and exclusion criteria are met, a consent form can be reviewed and signed at the time of their consultation/ evaluation clinic visit (in the presence of the PI, co-investigator, or study coordinator). 
• Alternatively, patients can be scheduled to meet with the study coordinator to review the study and consent at a later date. 
• The written consent form will be witnessed by the research coordinator and then scanned into the patient’s chart. 
• Symptoms will be assessed, and patients will be categorized into either the postprandial distress syndrome (PDS), epigastric pain syndrome (EPS), or mixed subtype, using Rome IV criteria.

Exclusion Criteria:

• Patients will be excluded from the study if symptoms are thought to represent an organic disorder (e.g., peptic ulcer disease, hepatitis, pancreatitis, inflammatory bowel disease, type I diabetes, a known malignancy, radiation-induced injury, an active infection, vasculitis, celiac disease), or if the patients have known uncontrolled GERD, esophagitis, eosinophilic esophagitis, or untreated H. pylori.  
• Patients with gastroparesis or cyclic vomiting syndrome will be excluded. 
• Patients with prior surgery to the esophagus, stomach or duodenum will be excluded. 
• Patients taking opioids will also be excluded. 
• Alcohol and tobacco use will be assessed, as will the presence of psychiatric conditions, such as anxiety, depression, post-traumatic stress disorder, bipolar disorders, and eating disorders, such as anorexia nervosa and bulimia.  However, no patients will be excluded based on reported substance use or presence of a psychiatric comorbidity. 
• If patients are found to have substance abuse issues or psychological issues after enrollment, they will also be referred to their primary care provider for further evaluation and treatment. 
• Patients with motion sickness, vertigo, or a seizure disorder will be excluded to prevent the theoretical risk of inducing or exacerbating symptoms related to the aforementioned conditions with VR. 
• Patients with co-existing IBS will be allowed to enter the study as long as IBS symptoms are not predominant.

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

Eligibility last updated 1/23/24. Questions regarding updates should be directed to the study team contact.

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

Eligibility last updated 2/ /23. Questions regarding updates should be directed to the study team contact.