Structure and Function of the Gastro-esophageal Junction

University of Zurich (UZH)

Status

Completed

Conditions

Gastroesophageal Reflux Disease

Treatments

Drug: Baclofen

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01053585

EK 1361

Details and patient eligibility

About

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) .

Enrollment

24 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No 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