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

University of Auckland, New Zealand

Status: Not yet enrolling

Conditions: Functional Dyspepsia; Gastroparesis

Treatments: Device: Gastric Alimetry

Study type: Observational

Funder types: Other

Identifiers

NCT06854120

AK-PRO-001

Details and patient eligibility

About

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.

Enrollment: 125 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

125 participants in 1 patient group

Treatment

Description:

Patients undergoing Body Surface Gastric Mapping before and after administration of prescribed prokinetic/neuromodulator

Treatment:

Device: Gastric Alimetry