Clinical trial: Validation of a Non-invasive In-vitro Diagnostic Test (Peptest) Against Other Diagnostic Methods for GERD (NCT02456779)

Eligibility criteria:
Inclusion Criteria:

        Case group:

          -  Patients diagnosed as gastroesophageal reflux disease within 6 months had endoscopy
             within 6 months and presented with reflux symptoms in the past 4 weeks.

          -  Patients with RDQ questionnaire score of no less than 12 points.

          -  Patients who met the requirements and signed the informed consent.

          -  Collection and processing of samples should comply with the requirements of laboratory
             operation rules and product specifications.

        Healthy group:

          -  Healthy subjects without any symptoms of gastroesophageal reflux, extra-esophageal
             reflux and laryngopharyngeal reflux.

          -  Healthy subjects with RDQ questionnaire score of 0.

          -  Healthy subjects with RSI questionnaire score of no more than 9 points and heartburn
             symptom score of 0.

          -  Healthy subjects who met the requirements and signed the informed consent.

          -  Collection and processing of samples should comply with the requirements of laboratory
             operation rules and product specifications.

        Exclusion Criteria:

          -  Patients with functional heartburn.

          -  Patients who took gastric motor drugs within 7 days after entering the study.

          -  Patients with esophageal spasm and achalasia, eosinophilic esophagitis, dysphagia,
             esophageal or gastric cancer, and patients who received esophagus and stomach surgery

          -  Patients with serious hypohepatia or renal insufficiency

          -  Pregnant women

          -  Patients whose saliva samples were not appropriate for detection

          -  Samples not meeting the collection and processing requirements.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.


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? Contradiction