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Structure and Function of the Gastro-esophageal Junction

This study has been completed.
Sponsor:
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT01053585
First received: July 21, 2009
Last updated: June 1, 2011
Last verified: May 2011
History of Changes
  Purpose

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) .

Condition Intervention
Gastroesophageal Reflux Disease
 Drug: Baclofen
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Combined Magnetic Resonance Imaging and High Resolution Manometry Studies

Resource links provided by NLM:

Drug Information available for: Baclofen
U.S. FDA Resources

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Gastro-oesophageal insertion angle, contact span (of stomach on oesophagus) [ Time Frame: Pre- and post-meal ingestion ] [ Designated as safety issue: No ]
    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:
  • gastric emptying [ Time Frame: post-meal ] [ Designated as safety issue: No ]
    dynamic change in gastric and meal volumes over course of study assessed from MRI imaging. gastric emptying assessed from complete data set

  • gastric accommodation [ Time Frame: post-meal ] [ Designated as safety issue: No ]
    dynamic change in gastric and meal volumes over course of study assessed from MRI imaging. gastric accommodation assessed from complete data set

  • number of reflux events [ Time Frame: post-meal ] [ Designated as safety issue: No ]
    assessed by presence of common cavity events on (high resolution) manometry


Enrollment: 24
Study Start Date: February 2007
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Baclofen
Baclofen suspension 40mg (single dose 90 minutes prior to physiologic measurement)
 Drug: Baclofen
Baclofen suspension 40mg (single dose 90 minutes prior to physiologic measurement)
Placebo Comparator: Placebo
Placebo suspension (single dose 90 minutes prior to physiologic measurement)
 Drug: Placebo
Placebo single 'dose' 90 minutes prior to study

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01053585

Locations
Switzerland
Division of Gastroenterology
Zurich, Switzerland, CH-8091
Sponsors and Collaborators
University of Zurich
Investigators
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
  More Information

No publications provided

Responsible Party: Dr. Mark Fox, University of Zurich
ClinicalTrials.gov Identifier: NCT01053585     History of Changes
Other Study ID Numbers: EK 1361
Study First Received: July 21, 2009
Last Updated: June 1, 2011
Health Authority: Switzerland: Ethikkommission

Keywords provided by University of Zurich:
Gastro-esophageal junction, reflux, insertion angle, magnetic resonance imaging, manometry

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Baclofen
GABA-B Receptor Agonists
GABA Agonists
GABA Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Muscle Relaxants, Central
Neuromuscular Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013