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NCT06854120Recruiting

Prokinetics and Body Surface Gastric Mapping in Dyspeptic Patients: Baseline and Treatment Effects

University of Auckland, New Zealand

Start Date

2/26/2025

Completion Date

8/26/2028

Summary

Functional dyspepsia and gastroparesis are common stomach disorders with symptoms like early satiety, nausea, and abdominal pain, and are often evaluated with gastric emptying tests, although the correlation with symptoms is weak. Prokinetic agents (e.g., metoclopramide, erythromycin) and symptom modulators (e.g., nortriptyline, mirtazapine) are commonly used, but selecting the right medication can be difficult, as it's often based on symptoms rather than the underlying gastric issues. Body Surface Gastric Mapping (BSGM) using the Gastric Alimetry device is a novel, non-invasive tool to assess gastric myoelectrical activity and symptoms. This study aims to perform two BSGM recordings-one before and one after medical therapy-to understand how medications affect gastric function and identify baseline BSGM factors that could predict responses to treatment, potentially guiding tailored therapies based on individual gastric dysfunction.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Patients 18 years of age and older * Diagnosis of gastroparesis and/or functional dyspepsia * Being prescribed a prokinetic agent or symptom modulator for their clinical care * Able to undergo BSGM recording both before and during treatment * Able to give informed consent for undergoing a baseline BSGM recording and an additional recording while on treatment Exclusion Criteria: * Under 18 years of age * Prior surgery on esophagus, stomach (appendectomy and cholecystectomy are allowed) * History of skin allergies or a history of extreme sensitivity to cosmetics or lotions * Pregnant women * No vulnerable groups such as prisoners, individuals with known cognitive impairment, or institutionalized individuals be involved

Interventions

DEVICE

Gastric Alimetry

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Conditions

GastroparesisFunctional Dyspepsia

Locations

Temple University

Philadelphia, Pennsylvania 19122

United States

Western Sydney University

Sydney, New South Wales 2560

Australia

Te Whatu Ora Waitemata

Auckland, Auckland 0622

New Zealand