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
This trial does not accept healthy volunteersQualifiers
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 population
Patients diagnosed with gastroparesis and/or functional dyspepsia who are prescribed prokinetics/neuromodulators.
Trial design
Cohort
Prospective
Treatments tested in this trial
Gastric Alimetry
DeviceThe Gastric Alimetry™ System is intended to record, store, view and process gastric myoelectrical activity as an aid in the diagnosis of various gastric disorders.
Treatment groups
Trial outcomes
Primary outcomes
Change in overall postprandial BSGM Gastric Alimetry Rhythm Index (minimum: 0; maximum: 1) on treatment compared to baseline (with a lower score meaning worse outcome).
Secondary outcomes
Change in overall BSGM BMI-Adjusted Amplitude on treatment compared to baseline (normal range: 22-70 μV).
Change in overall BSGM Principal Gastric Frequency (minimum: 0; maximum: 5) on treatment compared to baseline (normal range: 2.65-3.35 cpm).
Change in overall BSGM Fed:Fasted Amplitude Ratio on treatment compared to baseline (normal range: >1.08).
Sponsors and contacts
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University of Auckland, New Zealand
Lead sponsor
University of Western Sydney
Collaborator
Temple University
Collaborator
North Shore Hospital, New Zealand
Collaborator