Structure and Function of the Gastro-esophageal Junction

Not Applicable

Completed

• Conditions: Gastroesophageal Reflux Disease
• Interventions: Drug: Baclofen; Drug: Placebo

• Registration Number: NCT01053585
• Lead Sponsor: University of Zurich

Brief Summary

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) .

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2009-07-21
• Study First Submitted QC: 2010-01-20
• Study First Posted: 2010-01-21
• Status Verified: 2011-05
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Last Update Submitted: 2011-06-01
• Last Update Posted: 2011-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Baclofen	Baclofen	Baclofen suspension 40mg (single dose 90 minutes prior to physiologic measurement)
Placebo	Placebo	Placebo suspension (single dose 90 minutes prior to physiologic measurement)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
gastric accommodation	post-meal	dynamic change in gastric and meal volumes over course of study assessed from MRI imaging. gastric accommodation assessed from complete data set
gastric emptying	post-meal	dynamic change in gastric and meal volumes over course of study assessed from MRI imaging. gastric emptying assessed from complete data set
number of reflux events	post-meal	assessed by presence of common cavity events on (high resolution) manometry

Trial Locations

Locations (1)

Division of Gastroenterology; 🇨🇭 Zurich, Switzerland