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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Auckland, New Zealand
Study ID
NCT06854120
Status
Recruiting
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Conditions

  • Functional Dyspepsia
  • Gastroparesis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gastric Alimetry — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Feb 26, 2025
Status verified
Apr 2026
Primary completion
Feb 26, 2028
Completion
Aug 26, 2028

Study Design

Enrollment
125 participants (estimated)

Arms

  • Arm: Treatment
    Patients undergoing Body Surface Gastric Mapping before and after administration of prescribed prokinetic/neuromodulator

Primary Outcome Measure

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). [ Time Frame: 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Temple UniversityPhiladelphiaPennsylvania19122
Henry Parkman, PhD/MD
[email protected]
800-836-7536
Henry Parkman, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Temple University· Philadelphia, PA

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