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临床试验/NCT06213948
NCT06213948招募中1 期

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

Universiti Sains Malaysia1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2021年8月1日最近更新:
适应症
干预措施

试验速览

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)

研究概览

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Healthy

Experimental

干预措施: Mirtazapine 15 MG (Drug)

Functional Dyspepsia

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nashrulhaq Tagiling, MSc

PhD student

Universiti Sains Malaysia

研究点 (1)

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