Measurement of Gastric Secretion by MRI Under Inhibition by ProtonPump Inhibitors in Healthy Subjects & in GERD Patients

Healthy Volunteers Clinical Trial

Official title:

A Study for Measurement of Gastric Secretion by Magnetic Resonance Imaging (MRI) Under Inhibition of Gastric Secretion by Proton Pump Inhibitors in Healthy Subjects and Patients With Reflux Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01212614
• Other study ID #: KEK-ZH-Nr. 2010-0293
• Status: Completed
• Phase: N/A
• First received: September 29, 2010
• Last updated: September 11, 2012
• Start date: October 2010
• Est. completion date: September 2012

Study information

• Verified date: September 2012
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

This study bases on the successfully completed project SNF 320000-112006 (EK 1152 and SwissMedic 2005dr2207e) and will document the physiological effects of inhibited gastric secretion on the volume as well as the acidity of gastric secretion by high dose proton pump inhibitors in GERD patients and healthy controls. Twelve participants in each group will be studied in a randomized, double-blind placebo controlled trial. A novel non-invasive MRI technique developed in Zurich will assess the volume of gastric secretion following the ingestion of a regular liquid meal. In addition, intragastric / esophageal pH monitoring will assess the link between volume and intragastric distribution of gastric secretion on reflux events and symptoms. In addition, the effect of gastric secretion on outcome parameters of a non-invasive stable isotope breath test for measurement of gastric emptying will be assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion criteria: - Healthy volunteers must have less than one episode of reflux or dyspeptic symptoms per month of no more than mild severity in the last 3 months

• Reflux patients (GERD) must have chronic symptoms (>8 weeks) suggestive for GERD (definition and questionnaire see Appendix page 30). In addition, the initial screening manometry must show no severe esophageal dysmotility (e.g. spasm, achalasia). If in addition a pH-study has been performed the acid exposure must be > 4.2% / 24h.

Exclusion criteria: - Age under 18 or above 65

• Pathologic underweight or overweight (BMI < 18 or > 30 kg/m2)

• Previous history of gastrointestinal disease or surgery (excludes appendectomy, cholecystectomy, hernia repair and anorectal disorders)

• Previous cardiorespiratory (excludes arterial hypertension), hematologic, renal, atopic, alimentary or psychiatric disease, diabetes, drug or alcohol abuse

• Patient unable to stop medication that alters gut function for 72 hours prior to the study, including anticholinergics, prokinetics, proton-pump inhibitors, non-steroidal anti-inflammatory drugs

• Positive Helicobacter pylori status on 13C-Urea breath test

• Presence of metallic implants, devices or metallic foreign bodies

• Pregnancy and lactation (female patients of child bearing age will receive a pregnancy test prior to study)

• Female volunteers without adequate contraception for the duration of the study

• Involvement in any other clinical trial during the course of this trial, nor within a period of 30 days prior to its beginning or 30 days after its completion

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease
• Healthy Volunteers

Intervention

Procedure:
• MRI, non invasive 13C-breath test, 24h-intragastric / esophageal pH monitoring
MRI, non invasive 13C-breath test, 24h-intragastric/esophageal pH monitoring

Locations

Country	Name	City	State
Switzerland	University of Zurich	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	To assess the volume of gastric secretion in GERD patients and healthy volunteers with and without acid suppression.		October 2010 - October 2012	No