Prokinetics and Body Surface Gastric Mapping in Dyspeptic Patients: Baseline and Treatment Effects (NCT06854120) | Clinical Trial Compass
RecruitingNot Applicable
Prokinetics and Body Surface Gastric Mapping in Dyspeptic Patients: Baseline and Treatment Effects
United States, Australia, New Zealand125 participantsStarted 2025-02-26
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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).