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CompletedNCT01053585Updated Jun 2, 2011

Structure and Function of the Gastro-esophageal Junction

An interventional study of Baclofen and Placebo in Gastroesophageal Reflux Disease, sponsored by University of Zurich. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2011-06-02.

Sponsored by University of Zurich · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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) .
02

Conditions studied

  • Gastroesophageal Reflux Disease

Keywords

  • Gastro-esophageal junction, reflux, insertion angle, magnetic resonance imaging, manometry
03

In context

Gastroesophageal Reflux

1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.

This study's enrollment of 24 is below the median of 72 across 711 interventional studies indexed under Gastroesophageal Reflux.

Browse Gastroesophageal Reflux studies →

Lead sponsor

University of Zurich is the lead sponsor of 1,030 studies on the registry; 130 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Study #1:

  • healthy male and female volunteers
  • aged at least 18 and not more than 49 y
  • no history of gastrointestinal symptoms
  • able to communicate well with the investigators and to comply with the requirements for the entire study
  • who provided written informed consent before participating in the study, after being given a full description of the trail.

Study #2 and #3:

  • male and female patients with mild to moderate gastro-oesophageal reflux disease defined by presence of (1) reflux symptoms (2) pathological esophageal acid exposure between 5-10% on 24 hour ambulatory testing
  • aged at least 18 and not more than 49 y
  • no history of gastrointestinal symptoms
  • able to communicate well with the investigators and to comply with the requirements for the entire study
  • who provided written informed consent before participating in the study, after being given a full description of the trail.

Exclusion criteria

Exclusion criteria:

  • with present psychiatric disorders or mental impairment limiting the ability to comply with study requirements
  • with use of medications influencing upper GI motility within one week of the study (i.e. beta- blocker, calcium channel blockers, nitrates, prokinetic drugs, macrolide antibiotics)
  • with regular intake of medication; occasional use of analgesic e.g. aspirin, paracetamol is allowed
  • with symptoms or a history of gastrointestinal disease other than gastro-esophageal reflux disease (in study #2 and #3)
  • suffering from known liver, kidney, cardiovascular, neurological or pulmonary disease
  • with any evidence of infectious disease
  • with evidence or history of drug or alcohol abuse
  • with insufficient knowledge of the German language • who, for any reason, are unable to complete the study
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
24 participants (actual)

Study arms

  • Active comparator
    Baclofen

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

    Drug: Baclofen

  • Placebo comparator
    Placebo

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

    Drug: Placebo

Interventions

  • DrugBaclofen

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

  • DrugPlacebo

    Placebo single 'dose' 90 minutes prior to study

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. number of reflux events

    assessed by presence of common cavity events on (high resolution) manometry

    Time frame: post-meal

07

Study locations

1 site
  • Division of Gastroenterology
    Zurich, CH-8091, Switzerland
08

References and documents

Publications

  • Curcic J, Roy S, Schwizer A, Kaufman E, Forras-Kaufman Z, Menne D, Hebbard GS, Treier R, Boesiger P, Steingoetter A, Fried M, Schwizer W, Pal A, Fox M. Abnormal structure and function of the esophagogastric junction and proximal stomach in gastroesophageal reflux disease. Am J Gastroenterol. 2014 May;109(5):658-67. doi: 10.1038/ajg.2014.25. Epub 2014 Mar 4. PubMed 24589669 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 2, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01053585
Lead sponsor
University of Zurich
First posted
Jan 21, 2010
Start date
Feb 2007
Primary completion
May 2011
Completion
May 2011
Last update
Jun 2, 2011

Study contacts

01 Studienregister MasterAdmins
study director · UniversitaetsSpital Zuerich

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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