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临床试验/NCT01053585
NCT01053585已完成不适用

Combined Magnetic Resonance Imaging and High Resolution Manometry Studies

University of Zurich1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2007年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
1
主要终点
Gastro-oesophageal insertion angle, contact span (of stomach on oesophagus)

研究概览

简要总结

Aims of research project:

To identify key features of the gastro-esophageal junction (structure and function) that protects the esophagus from gastro-esophageal reflux investigated by combined high resolution manometry and magnetic resonance imaging.

Hypothesis:

  1. Functional factors including GEJ function (e.g. sphincter pressure) and proximal gastric distension determine whether or not TLESR occurs; however
  2. Structural factors including separation of GEJ anatomy, intra-gastric distribution of the meal and secretions determine whether TLESR is accompanied by no reflux event, gas reflux (belching) or reflux of ingested food and gastric secretion ('true reflux').
  3. Initial findings by descriptive studies in healthy volunteers (study #1) and patients with mild to moderate gastro-esophageal reflux disease (study #2) will be further interrogated by a randomized, double-blind control trial of baclofen in patients with GORD; a medication that inhibits reflux by effects on GOJ function (study #3) .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(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

Baclofen

Active Comparator

Baclofen suspension 40mg (single dose 90 minutes prior to physiologic measurement)

干预措施: Baclofen (Drug)

Placebo

Placebo Comparator

Placebo suspension (single dose 90 minutes prior to physiologic measurement)

干预措施: Placebo (Drug)

结局指标

主要结局

Gastro-oesophageal insertion angle, contact span (of stomach on oesophagus)

时间窗: Pre- and post-meal ingestion

Gastro-oesophageal morphology from MRI imaging: insertion angle, contact span (of stomach on oesophagus) assessed from 3D models of stomach reconstructed from MRI imaging

次要结局

  • gastric accommodation(post-meal)
  • gastric emptying(post-meal)
  • number of reflux events(post-meal)

研究者

申办方类型
Other

研究点 (1)

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