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Search / Trial NCT05836597

Functional Dyspepsia Treatment Using Virtual Reality

Launched by MAYO CLINIC · Apr 28, 2023

Trial Information

Current as of April 25, 2025

Recruiting

Keywords

ClinConnect Summary

**Summary of the Clinical Trial: Functional Dyspepsia Treatment Using Virtual Reality**

This clinical trial is exploring a new way to treat functional dyspepsia, which is a condition that causes discomfort or pain in the upper stomach without a clear medical cause. The researchers want to see if using virtual reality can help improve the symptoms related to this condition. The study is currently recruiting participants who are between the ages of 65 and 74 and those between 27 and 39 years old, regardless of gender.

To join the study, participants need to have been diagnosed with functional dyspepsia based on specific criteria and must have had an upper endoscopy to check for a common stomach infection called Helicobacter pylori. If someone has this infection, they will need to be treated for it before participating. People with certain other medical conditions, such as severe gastrointestinal disorders or those who have had specific surgeries, will not be eligible. Participants can expect to use virtual reality as part of their treatment, but more details on what that involves will be provided during the study. This trial could offer a new and innovative approach to managing symptoms of functional dyspepsia.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Symptoms of dyspepsia thought to represent functional dyspepsia, 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.
  • Exclusion Criteria:
  • 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 patients have known uncontrolled GERD, esophagitis, eosinophilic esophagitis, or untreated H. pylori.
  • Patients with gastroparesis or cyclic vomiting syndrome.
  • Patients with prior surgery to the esophagus, stomach or duodenum.
  • Patients taking opioids.
  • Patients with motion sickness, vertigo, or a seizure disorder
  • IBS symptoms are not predominant.

Trial Officials

David Cangemi

Principal Investigator

Mayo Clinic

About Mayo Clinic

Mayo Clinic is a renowned nonprofit medical practice and research institution dedicated to providing comprehensive healthcare and advancing medical knowledge through innovative research and education. With a commitment to patient-centered care, Mayo Clinic conducts numerous clinical trials aimed at exploring new therapies and improving treatment outcomes across various disciplines. Leveraging a multidisciplinary approach, the institution collaborates with leading experts and cutting-edge technology to ensure rigorous scientific standards and ethical practices in all its research endeavors. Through its trials, Mayo Clinic seeks to translate breakthroughs in science into tangible benefits for patients, fostering advancements in medicine that enhance health and quality of life.

Locations

Jacksonville, Florida, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported