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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01212614
First received: September 29, 2010
Last updated: September 11, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Gastroesophageal Reflux Disease
Healthy Volunteers
Procedure: MRI, non invasive 13C-breath test, 24h-intragastric / esophageal pH monitoring

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

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • To assess the volume of gastric secretion in GERD patients and healthy volunteers with and without acid suppression. [ Time Frame: October 2010 - October 2012 ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: October 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: MRI, non invasive 13C-breath test, 24h-intragastric / esophageal pH monitoring
    MRI, non invasive 13C-breath test, 24h-intragastric/esophageal pH monitoring
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01212614

Locations
Switzerland
University of Zurich
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Werner Schwizer, Professor MD University Hospital Zurich, Gastroenterology and Hepatology
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01212614     History of Changes
Other Study ID Numbers: KEK-ZH-Nr. 2010-0293
Study First Received: September 29, 2010
Last Updated: September 11, 2012
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014