Elucidating Mechanisms That Underlie Symptomatology of Functional Dyspepsia Using Novel Imaging Technique of SPECT/CT, MRI, High-Resolution Manometry and Biomarkers; and the Therapeutic Validation of Elucidated Mechanisms Using Neuromodulator Compounds
概览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Gastric volume (fasting and postprandial)
概览
简要总结
The goal of this study is to investigate the mechanisms of impaired gastric accommodation and emptying, dysfunctional duodenum, and micro-inflammation using novel imaging techniques of SPECT/CT, gastric emptying scintigraphy, MRI, high-resolution manometry, and inflammatory biomarkers, as well as to validate these mechanisms using a therapeutic trial of neuromodulator (mirtazapine) in functional dyspepsia (FD) and health. The main objective[s] it aims to answer are:
- to investigate impaired gastric accommodation through SPECT/CT imaging and high-resolution manometry findings of the stomach fundus.
- to investigate impaired gastric emptying through gastric emptying scintigraphy
- to investigate for a dysfunctional duodenum through MRI imaging of the duodenum.
- to investigate micro-inflammation through SPECT/CT standard uptake value (SUV), inflammatory biomarkers (eosinophils, mast cells, IL-6, IL-10) and mucosal barrier marker (E-cadherin).
- to investigate if a therapeutic trial of a neuromodulator agent, mirtazapine, ameliorates symptoms of FD through improvement in impaired gastric accommodation.
For objectives 1-4, FD patients and healthy volunteers will be consecutively recruited, and all will undergo SPECT/CT, MRI, high-resolution manometry and biomarkers, and data acquired from these tests will be analyzed. For objective 5, the enrolled participants who did all baseline tests/markers are given mirtazapine for four weeks, and all tests/markers, except biomarkers and MRI, are repeated at the end of the trial
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Healthy
干预措施: Mirtazapine 15 MG (Drug)
Functional Dyspepsia
干预措施: Mirtazapine 15 MG (Drug)
结局指标
主要结局
Gastric volume (fasting and postprandial)
时间窗: Fasting, 10-min. postprandial
SPECT/CT volumetry
Gastric emptying profile (4 hours)
时间窗: Immediately after test meal ingestion, up to 4 hours postprandial
Gastric emptying scintigraphy
Intragastric pressure
时间窗: Fasting, up to 30-min. postprandial after reaching maximum tolerated volume
High-resolution manometry
次要结局
- Satiation(Fasting, up to 30-min. postprandial after reaching maximum tolerated volume)
- Upper gastrointestinal symptoms(Fasting, up to 30-min. postprandial after reaching maximum tolerated volume)
研究者
Nashrulhaq Tagiling, MSc
PhD student
Universiti Sains Malaysia