Functional Dyspepsia, Gastroparesis
Conditions
Keywords
Gastroparesis, Functional Dyspepsia, Gastric Motility, Body Surface Gastric Mapping
Brief 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.
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.
Sponsors
University of Auckland, New Zealand
University of Western Sydney
Temple University
North Shore Hospital, New Zealand
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| 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). | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change in overall BSGM BMI-Adjusted Amplitude on treatment compared to baseline (normal range: 22-70 μV). | 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). | 8 weeks |
| Change in overall BSGM Fed:Fasted Amplitude Ratio on treatment compared to baseline (normal range: >1.08). | 8 weeks |
Countries
Australia, New Zealand, United States
Contacts
CONTACTGenevieve M Johnston, PhD
PRINCIPAL_INVESTIGATORHenry Parkman, MD
Temple University
PRINCIPAL_INVESTIGATORVincent Ho, MBBS, FRACP, FACP, PhD
University of Western Sydney
PRINCIPAL_INVESTIGATORCharlotte Daker, MD
University of Auckland, New Zealand
PRINCIPAL_INVESTIGATORGreg O'Grady, MD, PhD
University of Auckland, New Zealand
Outcome results
None listed