Structure and Function of the Gastro-esophageal Junction

• Sponsor: University of Zurich (Other)
• Overall Status: Completed
• CT.gov ID: NCT01053585
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Duration (Months): 50.9
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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) .

Condition or Disease	Intervention/Treatment	Phase
Gastroesophageal Reflux Disease	Drug: Baclofen; Drug: Placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Diagnostic
• Official Title: Combined Magnetic Resonance Imaging and High Resolution Manometry Studies
• Study Start Date: Feb 1, 2007
• Actual Primary Completion Date: May 1, 2011
• Actual Study Completion Date: May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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

3. number of reflux events [post-meal]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: 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:

• 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

Locations

	Site	City	State	Country	Postal Code
1	Division of Gastroenterology	Zurich		Switzerland	CH-8091

Sponsors and Collaborators

• University of Zurich

Investigators

• Study Director: 01 Studienregister MasterAdmins, UniversitaetsSpital Zuerich

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01053585
• Other Study ID Numbers: EK 1361
• First Posted: Jan 21, 2010
• Last Update Posted: Jun 2, 2011
• Last Verified: May 1, 2011

• Keywords provided by , ,: Gastro-esophageal junction, reflux, insertion angle, magnetic resonance imaging, manometry
• Additional relevant MeSH terms: Gastroesophageal Reflux; Baclofen

Study Results

No Results Posted as of Jun 2, 2011