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Completed

NCT Number: NCT01053585

Structure and Function of the Gastro-esophageal Junction

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) .

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Key information

Conditions

Gastroesophageal Reflux Disease Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Gastroenterology

Zurich, Canton of Zurich, CH-8091, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Baclofen

Drug

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

Placebo

Drug

Placebo single 'dose' 90 minutes prior to study

Primary outcomes

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

    Time frame: 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 outcomes

  1. gastric emptying

    Time frame: post-meal

    dynamic change in gastric and meal volumes over course of study assessed from MRI imaging. gastric emptying assessed from complete data set

  2. gastric accommodation

    Time frame: post-meal

    dynamic change in gastric and meal volumes over course of study assessed from MRI imaging. gastric accommodation assessed from complete data set

  3. number of reflux events

    Time frame: post-meal

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

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

Combined Magnetic Resonance Imaging and High Resolution Manometry Studies

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Jan 21, 2010
Registry last updated
Jun 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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