NCT06854120 Prokinetics and Body Surface Gastric Mapping in Dyspeptic Patients: Baseline and Treatment Effects
| NCT ID | NCT06854120 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Auckland, New Zealand |
| Condition | Gastroparesis |
| Study Type | OBSERVATIONAL |
| Enrollment | 125 participants |
| Start Date | 2025-02-26 |
| Primary Completion | 2028-02-26 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 125 participants in total. It began in 2025-02-26 with a primary completion date of 2028-02-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Henry Parkman, MD
PRINCIPAL INVESTIGATOR
Temple University
Frequently Asked Questions
Who can join the NCT06854120 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gastroparesis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06854120 currently recruiting?
Yes, NCT06854120 is actively recruiting participants. Contact the research team at gen.johnston@auckland.ac.nz for enrollment information.
Where is the NCT06854120 trial being conducted?
This trial is being conducted at Philadelphia, United States, Sydney, Australia, Auckland, New Zealand.
Who is sponsoring the NCT06854120 clinical trial?
NCT06854120 is sponsored by University of Auckland, New Zealand. The principal investigator is Henry Parkman, MD at Temple University. The trial plans to enroll 125 participants.