Structure and Function of the Gastro-esophageal Junction

Gastroesophageal Reflux Disease Clinical Trial

Official title:

Combined Magnetic Resonance Imaging and High Resolution Manometry Studies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01053585
• Other study ID #: EK 1361
• Status: Completed
• Phase: N/A
• First received: July 21, 2009
• Last updated: June 1, 2011
• Start date: February 2007
• Est. completion date: May 2011

Study information

• Verified date: May 2011
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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) .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Drug:
• Baclofen
Baclofen suspension 40mg (single dose 90 minutes prior to physiologic measurement)
• Placebo
Placebo single 'dose' 90 minutes prior to study

Locations

Country	Name	City	State
Switzerland	Division of Gastroenterology	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pre- and post-meal ingestion	No
Secondary	gastric emptying	dynamic change in gastric and meal volumes over course of study assessed from MRI imaging. gastric emptying assessed from complete data set	post-meal	No
Secondary	gastric accommodation	dynamic change in gastric and meal volumes over course of study assessed from MRI imaging. gastric accommodation assessed from complete data set	post-meal	No
Secondary	number of reflux events	assessed by presence of common cavity events on (high resolution) manometry	post-meal	No