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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Auckland, New Zealand

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Gastric Alimetry

Treatment groups

125 Participants
are divided into 1 treatment group

Locations

3
Australia
Western Sydney University2560, SydneyNew South Wales, Australia
New Zealand
Te Whatu Ora Waitemata0622, AucklandAuckland, New Zealand
United States
Temple University19122, PhiladelphiaPennsylvania, United States

Sponsors and collaborators

University of Auckland, New Zealand

Lead sponsor

University of Western Sydney

Collaborator

Temple University

Collaborator

North Shore Hospital, New Zealand

Collaborator