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) .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Enrollment
24
Baclofen suspension 40mg (single dose 90 minutes prior to physiologic measurement)
Placebo single 'dose' 90 minutes prior to study
Division of Gastroenterology
Zurich, Canton of Zurich, Switzerland
Gastro-oesophageal insertion angle, contact span (of stomach on oesophagus)
Gastro-oesophageal morphology from MRI imaging: insertion angle, contact span (of stomach on oesophagus) assessed from 3D models of stomach reconstructed from MRI imaging
Time frame: Pre- and post-meal ingestion
gastric emptying
dynamic change in gastric and meal volumes over course of study assessed from MRI imaging. gastric emptying assessed from complete data set
Time frame: post-meal
gastric accommodation
dynamic change in gastric and meal volumes over course of study assessed from MRI imaging. gastric accommodation assessed from complete data set
Time frame: post-meal
number of reflux events
assessed by presence of common cavity events on (high resolution) manometry
Time frame: post-meal
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