Structure and Function of the Gastro-esophageal Junction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2011-05-31

Brief Summary

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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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Detailed Description

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Conditions

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Gastroesophageal Reflux Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Baclofen

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

Group Type ACTIVE_COMPARATOR

Baclofen

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo single 'dose' 90 minutes prior to study

Interventions

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Baclofen

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

Intervention Type DRUG

Placebo

Placebo single 'dose' 90 minutes prior to study

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No