RecruitingNCT06854120

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

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


Sponsor

University of Auckland, New Zealand

Enrollment

125 participants

Start Date

Feb 26, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria5

  • 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

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Interventions

DEVICEGastric 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.


Locations(3)

Temple University

Philadelphia, Pennsylvania, United States

Western Sydney University

Sydney, New South Wales, Australia

Te Whatu Ora Waitemata

Auckland, Auckland, New Zealand

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NCT06854120


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