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NCT Number: NCT06854120

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

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.

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Key information

Conditions

Gastroparesis Digestive System Diseases Functional Dyspepsia Gastrointestinal Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomach Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Western Sydney University, Sydney, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Genevieve M Johnston, PhD

CONTACT

[email protected]

+64 9 373 7599

Sponsors and collaborators

Lead sponsor

University of Auckland, New Zealand

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Mar 3, 2025
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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