Body Surface Gastric Mapping in Patients With Dyspeptic Symptoms: Recordings at Baseline and on Medical Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 125
- 试验地点
- 3
- 主要终点
- 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).
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Treatment
Patients undergoing Body Surface Gastric Mapping before and after administration of prescribed prokinetic/neuromodulator
干预措施: Gastric Alimetry (Device)
结局指标
主要结局
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).
时间窗: 8 weeks
次要结局
- 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)
研究者
Greg O'Grady
MD/PhD
University of Auckland, New Zealand