Status:
COMPLETED
Measurement of Gastric Secretion by MRI Under Inhibition by ProtonPump Inhibitors in Healthy Subjects & in GERD Patients
Lead Sponsor:
University of Zurich
Conditions:
Gastroesophageal Reflux Disease
Healthy Volunteers
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 a...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01212614
Start Date
October 1 2010
End Date
September 1 2012
Last Update
September 12 2012
Active Locations (1)
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1
University of Zurich
Zurich, Switzerland, 8091