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| Name | Class |
|---|---|
| University of Western Sydney | OTHER |
| Temple University | OTHER |
| North Shore Hospital, New Zealand | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Patients undergoing Body Surface Gastric Mapping before and after administration of prescribed prokinetic/neuromodulator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gastric Alimetry | Device | The Gastric Alimetryâ„¢ System is intended to record, store, view and process gastric myoelectrical activity as an aid in the diagnosis of various gastric disorders. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with gastroparesis and/or functional dyspepsia who are prescribed prokinetics/neuromodulators.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Genevieve M Johnston, PhD | Contact | +64 9 373 7599 | gen.johnston@auckland.ac.nz |
| Name | Affiliation | Role |
|---|---|---|
| Henry Parkman, MD | Temple University | Principal Investigator |
| Vincent Ho, MBBS, FRACP, FACP, PhD | University of Western Sydney | Principal Investigator |
| Charlotte Daker, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Temple University | Not yet recruiting | Philadelphia | Pennsylvania | 19122 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36534985 | Background | 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. | |
| 37782524 |
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The study design means that no identifiable data will be shared beyond immediate study researchers at each location.
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| ID | Term |
|---|---|
| D018589 | Gastroparesis |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
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| 8 weeks |
| Change in overall BSGM Fed:Fasted Amplitude Ratio on treatment compared to baseline (normal range: >1.08). | 8 weeks |
| University of Auckland, New Zealand |
| Principal Investigator |
| Greg O'Grady, MD, PhD | University of Auckland, New Zealand | Principal Investigator |
| Western Sydney University | Recruiting | Sydney | New South Wales | 2560 | Australia |
|
| Te Whatu Ora Waitemata | Recruiting | Auckland | Auckland | 0622 | New Zealand |
|
| 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. |
| 36130019 | 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. |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |