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

This trial does not accept healthy volunteers

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 population

Patients diagnosed with gastroparesis and/or functional dyspepsia who are prescribed prokinetics/neuromodulators.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Gastric Alimetry

    Device

    The 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

125 Participants
are divided into 1 treatment group
Group A: Treatment1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
8 weeks

Secondary outcomes

1

Change in overall BSGM BMI-Adjusted Amplitude on treatment compared to baseline (normal range: 22-70 μV).

Time frame
8 weeks
2

Change in overall BSGM Principal Gastric Frequency (minimum: 0; maximum: 5) on treatment compared to baseline (normal range: 2.65-3.35 cpm).

Time frame
8 weeks
3

Change in overall BSGM Fed:Fasted Amplitude Ratio on treatment compared to baseline (normal range: >1.08).

Time frame
8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Auckland, New Zealand

Lead sponsor

University of Western Sydney

Collaborator

Temple University

Collaborator

North Shore Hospital, New Zealand

Collaborator