Clinical trial: Efficacy of Zinc L-carnosine in Maintaining Remission of Gastroesophageal Reflux Disease (NCT03467438)

Eligibility criteria:
Inclusion Criteria:

          -  written informed consent to participate

          -  be male or female patients ≥ 18 years old, with an established diagnosis of GERD

          -  have a diagnosis of GERD that is established clinically in case of typical symptoms
             (heartburn and acid regurgitation ≥ once weekly) or with 24-hour esophageal impedence
             monitoring in case of atypical symptoms not responsive to proton pump inhibitors
             (PPIs) or in case of unclear diagnosis

          -  have been treated with an 8-week course of PPI (as per gold-standard treatment of
             GERD) before entering the study

        Exclusion Criteria:

          -  any medical condition that requires chronic therapy with PPIs or H2 antagonists;
             anti-acid agents must be discontinued within the study period

          -  oesophageal motility disorders

          -  allergy or intolerance to Hepilor® (it contains parahydroxybenzoate that may cause
             allergies)

               -  inconclusive diagnosis of GERD and related symptoms

               -  patients with active H. pylori infection (diagnosed with any of the available
                  tests)

               -  previous major oesophageal surgery

               -  history of any advanced/relevant organ dysfunction, in particular chronic kidney
                  disease, chronic liver disease of any aetiology, hearth failure

               -  any concomitant medical condition with a poor prognosis (< 3 months)

               -  pregnant females

               -  inability to conform to the protocol

               -  treatment with any investigational drug within the previous 3 months

               -  any subject not able to express/understand the informed consent
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.


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? 0