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

June 8, 2026 updated by: Greg O'Grady, University of Auckland, New Zealand

Body Surface Gastric Mapping in Patients With Dyspeptic Symptoms: Recordings at Baseline and on Medical Therapy

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

125

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2560
        • Recruiting
        • Western Sydney University
        • Contact:
        • Principal Investigator:
          • Vincent Ho, MBBS, FRACP, FACP, PhD
  • New Zealand
    • Auckland
      • Auckland, Auckland, New Zealand, 0622
        • Recruiting
        • Te Whatu Ora Waitemata
        • Contact:
        • Principal Investigator:
          • Charlotte Daker, MD
  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19122
        • Not yet recruiting
        • Temple University
        • Contact:
        • Principal Investigator:
          • Henry Parkman, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Treatment
Patients undergoing Body Surface Gastric Mapping before and after administration of prescribed prokinetic/neuromodulator
Device: Gastric Alimetry
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in overall BSGM BMI-Adjusted Amplitude on treatment compared to baseline (normal range: 22-70 μV).
Time Frame: 8 weeks
8 weeks
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
8 weeks
Change in overall BSGM Fed:Fasted Amplitude Ratio on treatment compared to baseline (normal range: >1.08).
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Auckland, New Zealand

Collaborators

Temple University
University of Western Sydney
North Shore Hospital, New Zealand

Investigators

  • Principal Investigator: Henry Parkman, MD, Temple University
  • Principal Investigator: Vincent Ho, MBBS, FRACP, FACP, PhD, University of Western Sydney
  • Principal Investigator: Charlotte Daker, MD, University of Auckland, New Zealand
  • Principal Investigator: Greg O'Grady, MD, PhD, University of Auckland, New Zealand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2025

Primary Completion (Estimated)

February 26, 2028

Study Completion (Estimated)

August 26, 2028

Study Registration Dates

First Submitted

February 25, 2025

First Submitted That Met QC Criteria

February 25, 2025

First Posted (Actual)

March 3, 2025

Study Record Updates

Last Update Posted (Actual)

June 11, 2026

Last Update Submitted That Met QC Criteria

June 8, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AK-PRO-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The study design means that no identifiable data will be shared beyond immediate study researchers at each location.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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