Clinical trial NCT06854120: Prokinetics and Body Surface Gastric Mapping in Dyspeptic Patients: Baseline and Treatment Effects
Official title: Body Surface Gastric Mapping in Patients With Dyspeptic Symptoms: Recordings at Baseline and on Medical Therapy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Gastroparesis
Functional Dyspepsia
Keywords: Gastroparesis
Functional Dyspepsia
Gastric Motility
Body Surface Gastric Mapping
Lead sponsor: University of Auckland, New Zealand
Sponsor class: OTHER
Collaborators: name: University of Western Sydney
name: Temple University
name: North Shore Hospital, New Zealand
First posted: 2025-03-03
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with gastroparesis and/or functional dyspepsia who are prescribed prokinetics/neuromodulators.

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

Primary outcomes:
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).
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in overall BSGM BMI-Adjusted Amplitude on treatment compared to baseline (normal range: 22-70 μV).
timeFrame: 8 weeks
measure: Change in overall BSGM Principal Gastric Frequency (minimum: 0; maximum: 5) on treatment compared to baseline (normal range: 2.65-3.35 cpm).
timeFrame: 8 weeks
measure: Change in overall BSGM Fed:Fasted Amplitude Ratio on treatment compared to baseline (normal range: >1.08).
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Sydney
country: Australia
facility: Western Sydney University
state: New South Wales
city: Auckland
country: New Zealand
facility: Te Whatu Ora Waitemata
Study officials:
affiliation: Temple University
name: Henry Parkman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Western Sydney
name: Vincent Ho, MBBS, FRACP, FACP, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Auckland, New Zealand
name: Charlotte Daker, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Auckland, New Zealand
name: Greg O'Grady, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.