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Structure and Function of the Gastro-esophageal Junction

Primary Purpose

Gastroesophageal Reflux Disease

Status

Completed

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

Baclofen

Placebo

About this trial

This is an interventional diagnostic trial for Gastroesophageal Reflux Disease focused on measuring Gastro-esophageal junction, reflux, insertion angle, magnetic resonance imaging, manometry

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Division of Gastroenterology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Baclofen

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

gastric emptying

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

gastric accommodation

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

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

Full Information

NCT ID

NCT01053585

First Posted

July 21, 2009

Last Updated

June 1, 2011

Sponsor

University of Zurich

1. Study Identification

Unique Protocol Identification Number

NCT01053585

Brief Title

Structure and Function of the Gastro-esophageal Junction

Official Title

Combined Magnetic Resonance Imaging and High Resolution Manometry Studies

Study Type

Interventional

2. Study Status

Record Verification Date

May 2011

Overall Recruitment Status

Completed

Study Start Date

February 2007 (undefined)

Primary Completion Date

May 2011 (Actual)

Study Completion Date

May 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Zurich

4. Oversight

Data Monitoring Committee

5. 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: Functional factors including GEJ function (e.g. sphincter pressure) and proximal gastric distension determine whether or not TLESR occurs; however 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'). 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) .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastroesophageal Reflux Disease

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Baclofen

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Baclofen

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo single 'dose' 90 minutes prior to study

Primary Outcome Measure Information:

Title

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

Description

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 Outcome Measure Information:

Title

gastric emptying

Description

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

Title

gastric accommodation

Description

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

Title

number of reflux events

Description

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

Time Frame

post-meal

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

01 Studienregister MasterAdmins

Organizational Affiliation

UniversitaetsSpital Zuerich

Official's Role

Study Director

Facility Information:

Facility Name

Division of Gastroenterology

City

Zurich

ZIP/Postal Code

CH-8091

Country

Switzerland

12. IPD Sharing Statement

Citations:

PubMed Identifier

24589669

Citation

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.

Results Reference

derived

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Structure and Function of the Gastro-esophageal Junction

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