Synergistic Gut-brain Axis Modulation Via Vagal Stimulation and Support Therapy in Functional Dyspepsia
Trial Parameters
Brief Summary
The study aims at evaluating physiological and patient-reported outcomes for a dual intervention approach including a stimulation device and support therapy in patients with functional dyspepsia.
Eligibility Criteria
Inclusion Criteria: Age 18-65 years old (inclusive) * Ability to give written consent and participate in behavioral intervention in English * Willingness to attend weekly treatment sessions over live video, daily self-administered transcutaneous auricular vagus nerve stimulation (taVNS) sessions, and engage in homework during treatment * Avoidance of alcohol, nicotine, and caffeine for 24 hours prior to study session * Diagnosis according to the Rome IV criteria for both epigastric pain syndrome and postprandial distress syndrome subtypes * Stable medical treatment for functional dyspepsia (FD) during 1 month before the study and during the study period Exclusion Criteria: * Previous receipt of cognitive behavioral therapy (CBT) for gastrointestinal symptoms * Enteral or parenteral feeding * Previous gastrointestinal surgery, electrolyte disturbances, kidney dysfunction, renal insufficiency, or iron overload disorders * Estimated Glomerular Filtration Rate (eGFR) \< 60 * Medications th