Clinical trial: Measurement of Gastric Secretion by MRI Under Inhibition by ProtonPump Inhibitors in Healthy Subjects & in GERD Patients (NCT01212614)

Eligibility 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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years

Patient description (medical language): A 48-year-old man comes to the office complaining of heartburn and acid reflux.  He has taken over-the-counter antacids but sees no relief.  Other medical history is unremarkable.  The patient does not use tobacco, alcohol, or illicit drugs.  Vital signs are within normal limits.  BMI is 31 kg/m2.  Physical examination is  positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart.  A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus.

Patient description (patient's own words): I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm!

Does the patient match the trial criteria? 1