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

NCT06854120 | Not Yet Recruiting FDA Device

• 1 other identifier: AK-PRO-001
• Study Type: observational
• Target: 125
• Locations: 3 countries
• Sites: 3

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.

Conditions

Gastroparesis; Functional Dyspepsia

Keywords

Gastroparesis; Functional Dyspepsia; Gastric Motility; Body Surface Gastric Mapping

Outcome Measures

Primary Outcomes (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).

  8 weeks

Secondary Outcomes (3)

• 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

Study Arms (1)

Treatment

Patients undergoing Body Surface Gastric Mapping before and after administration of prescribed prokinetic/neuromodulator

Device: Gastric Alimetry

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.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with gastroparesis and/or functional dyspepsia who are prescribed prokinetics/neuromodulators.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Auckland, New Zealand: lead
• University of Western Sydney: collaborator
• Temple University: collaborator
• North Shore Hospital, New Zealand: collaborator

Study Sites (3)

Temple University

Philadelphia, Pennsylvania, 19122, United States

Location

Western Sydney University

Sydney, New South Wales, 2560, Australia

Location

Te Whatu Ora Waitemata

Auckland, Auckland, 0622, New Zealand

Location

Related Publications (3)

• Varghese C, Schamberg G, Calder S, Waite S, Carson D, Foong D, Wang WJ, Ho V, Woodhead J, Daker C, Xu W, Du P, Abell TL, Parkman HP, Tack J, Andrews CN, O'Grady G, Gharibans AA. Normative Values for Body Surface Gastric Mapping Evaluations of Gastric Motility Using Gastric Alimetry: Spectral Analysis. Am J Gastroenterol. 2023 Jun 1;118(6):1047-1057. doi: 10.14309/ajg.0000000000002077. Epub 2022 Dec 20.

  PMID: 36534985 BACKGROUND

• Wang WJ, Foong D, Calder S, Schamberg G, Varghese C, Tack J, Xu W, Daker C, Carson D, Waite S, Hayes T, Du P, Abell TL, Parkman HP, Huang IH, Fernandes V, Andrews CN, Gharibans AA, Ho V, O'Grady G. Gastric Alimetry Expands Patient Phenotyping in Gastroduodenal Disorders Compared with Gastric Emptying Scintigraphy. Am J Gastroenterol. 2024 Feb 1;119(2):331-341. doi: 10.14309/ajg.0000000000002528. Epub 2023 Oct 30.

  PMID: 37782524 BACKGROUND

• Gharibans AA, Calder S, Varghese C, Waite S, Schamberg G, Daker C, Du P, Alighaleh S, Carson D, Woodhead J, Farrugia G, Windsor JA, Andrews CN, O'Grady G. Gastric dysfunction in patients with chronic nausea and vomiting syndromes defined by a noninvasive gastric mapping device. Sci Transl Med. 2022 Sep 21;14(663):eabq3544. doi: 10.1126/scitranslmed.abq3544. Epub 2022 Sep 21.

  PMID: 36130019 BACKGROUND

MeSH Terms

Conditions

Gastroparesis

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Henry Parkman, MD

  Temple University

  PRINCIPAL INVESTIGATOR

• Vincent Ho, MBBS, FRACP, FACP, PhD

  University of Western Sydney

  PRINCIPAL INVESTIGATOR

• Charlotte Daker, MD

  University of Auckland, New Zealand

  PRINCIPAL INVESTIGATOR

• Greg O'Grady, MD, PhD

  University of Auckland, New Zealand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Genevieve M Johnston, PhD

CONTACT

+64 9 373 7599; gen.johnston@auckland.ac.nz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD/PhD

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 3, 2025
• Study Start: February 26, 2025
• Primary Completion (Estimated): February 26, 2028
• Study Completion (Estimated): August 26, 2028
• Last Updated: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); AU (1); NZ (1)