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

Not yet recruiting

• Conditions: Gastroparesis; Functional Dyspepsia

• Registration Number: NCT06854120
• Lead Sponsor: University of Auckland, New Zealand

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-25
• Study First Submitted QC: 2025-02-25
• Last Update Submitted: 2025-02-25
• Study Start: 2025-02-26
• Study First Posted: 2025-03-03
• Last Update Posted: 2025-03-03
• Primary Completion: 2028-02-26
• Study Completion: 2028-08-26

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 125

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change in overall BSGM Fed:Fasted Amplitude Ratio on treatment compared to baseline (normal range: >1.08).	8 weeks
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

Trial Locations

Locations (3)

Temple University; 🇺🇸 Philadelphia, Pennsylvania, United States

Western Sydney University; 🇦🇺 Sydney, New South Wales, Australia

Te Whatu Ora Waitemata; 🇳🇿 Auckland, New Zealand