Clinical trial: Study in Patients Suffering From Heartburn and Backward Flow of Stomach Liquid Into the Esophagus (NCT04059900)

Eligibility criteria:
Inclusion Criteria:

          1. Patients of either sex aged 18-80 years.

          2. Diagnosis of functional dyspepsia according to Rome III criteria:

               -  Pain or burning localized to the epigastrium of at least moderate severity at
                  least once per week with a total duration of at least 6 months.

               -  Pain was intermittent.

               -  Pain was not generalized or localized to other abdominal or chest regions.

               -  Pain was not relieved by defecation or passage of flatus.

               -  Pain did not fulfil criteria for gallbladder and sphincter of Oddi disorders.

          3. At assessment (visit 1 or 3) three items of GIS had to be judged at least as moderate
             including reflux symptoms, but reflux symptoms not dominating the clinical picture.

          4. Endoscopy of the upper gastrointestinal tract and abdominal sonography without
             pathological findings that could have explained the symptoms (findings of up to 5
             gastric erosions could be tolerated if patient had no concomitant intake of
             acetylsalicylic acid).

          5. Patients willing to comply with the study protocol.

          6. Patients who were able to understand and provide written informed consent to
             participate in the trial (signed informed consent).

        Exclusion Criteria:

          1. Concomitant treatment during the study with any medication that could influence the
             gastrointestinal function (e.g. prokinetics, antacids, antibiotics, antidepressant,
             laxatives, calcium antagonists, beta-blocker, antidiarrheics).

          2. Regular intake of nonsteroidal antiphlogistic drugs incl. cyclooxygenase-2
             (COX-2)-inhibitors (exception: acetylsalicylic acid for cardiovascular prevention up
             to 100 mg daily).

          3. History of clinically relevant gastrointestinal disease such as gastric-, pancreatic-,
             colon-, rectal-cancer.

          4. History of gastric and/or duodenal ulcer.

          5. History of abdominal surgery (cholecystectomy and appendectomy could be tolerated).

          6. History and/or presence of coronary heart disease.

          7. Known intolerance to azo dyes E 110 and E 151.

          8. Food allergies and known lactose intolerance.

          9. Evidence of any gastrointestinal infectious diseases.

         10. Participation in a clinical trial 30 days prior to this trial.

         11. Concurrent participation in another clinical trial.

         12. Female patients of childbearing potential with a positive pregnancy test, breast
             feeding, or female patients of childbearing potential without adequate contraception.

         13. History and/or presence of drug or alcohol abuse.

         14. Patients with psychiatric illness.

         15. Irritable bowel syndrome.
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 80 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? Entailment