Clinical trial: Functional Dyspepsia and Symptom Perception (NCT02522000)

Eligibility criteria:
Healthy volunteers

        Inclusion criteria:

        - No gastrointestinal symptoms or history of gastrointestinal disease meeting ROME III
        criteria for functional dyspepsia and Irritable Bowel Syndrome (IBS).

        Exclusion criteria:

          -  Inability to stop the intake of nonsteroidal antiinflammatory drugs (NSAIDs) within 14
             days prior to endoscopy and within two days prior to multi-sugar test.

          -  Inability to stop the intake of medication affecting gastrointestinal function (e.g.
             proton pump inhibitors, prokinetics, laxatives) within 5 days prior to endoscopy,
             multi-sugar test and combined meal- and gastric emptying test

          -  Current use of antidepressants

          -  Medical history of diabetes mellitus

          -  Medical history of coeliac disease

          -  Organic disease at upper gastrointestinal endoscopy (i.e. erosive esophagitis,
             Barrett's esophagus, benign esophageal stricture, Schatzki ring, esophageal carcinoma,
             esophageal candidiasis, gastric ulcer, gastric erosions, gastric cancer, duodenal
             erosions or duodenal ulcer)

          -  First-degree family members with diabetes mellitus type I, coeliac disease, Crohn's
             disease or ulcerative colitis

          -  Medical history of food allergy or anamnestic evidence of food allergy

          -  Presence of coagulation disorders or use of the following anticoagulants: coumarin
             derivates, new oral anticoagulants (NOACs: dabigatran, apixaban and rivaroxaban), and
             clopidogrel (Patients or healthy controls using calcium carbasalate (acetylsalicylic
             acid 100mg 1dd1) are eligible to participate in the study. Patients or healthy
             controls using higher doses of calcium carbasalate will be excluded from the study).

          -  Dieting

          -  Pregnancy or lactation

          -  Smoking

          -  Excessive alcohol use (>20 alcoholic consumptions/week) and inability to avoid use of
             alcohol in the 2 days prior to endoscopy and multi-sugar test

        Functional dyspepsia patients

        Inclusion criteria:

        - Patients referred for upper gastrointestinal endoscopy by either general practitioners or
        physicians from the gastroenterology outpatient clinic and meeting ROME III criteria for
        functional dyspepsia.

        Exclusion criteria:

          -  Inability to stop the intake of nonsteroidal antiinflammatory drugs (NSAIDs) within 14
             days prior to endoscopy and within two days prior to multi-sugar test.

          -  Inability to stop the intake of medication affecting gastrointestinal function (e.g.
             proton pump inhibitors, prokinetics, laxatives) within 5 days prior to endoscopy,
             multi-sugar test and combined meal- and gastric emptying test

          -  Current use of antidepressants

          -  Medical history of diabetes mellitus

          -  Medical history of coeliac disease

          -  Organic disease at upper gastrointestinal endoscopy (i.e. erosive esophagitis,
             Barrett's esophagus, benign esophageal stricture, Schatzki ring, esophageal carcinoma,
             esophageal candidiasis, gastric ulcer, gastric erosions, gastric cancer, duodenal
             erosions or duodenal ulcer)

          -  First-degree family members with diabetes mellitus type I, coeliac disease, Crohn's
             disease or ulcerative colitis

          -  Medical history of food allergy or anamnestic evidence of food allergy

          -  Presence of coagulation disorders or use of the following anticoagulants: coumarin
             derivates, new oral anticoagulants (NOACs: dabigatran, apixaban and rivaroxaban), and
             clopidogrel (Patients or healthy controls using calcium carbasalate (acetylsalicylic
             acid 100mg 1dd1) are eligible to participate in the study. Patients or healthy
             controls using higher doses of calcium carbasalate will be excluded from the study).

          -  Dieting

          -  Pregnancy or lactation

          -  Smoking

          -  Excessive alcohol use (>20 alcoholic consumptions/week) and inability to avoid use of
             alcohol in the 2 days prior to endoscopy and multi-sugar test
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 65 Years

Patient description (medical language): A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands.

Patient description (patient's own words): I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated...

Does the patient match the trial criteria? Contradiction