Clinical trial: Mipolixin® Compared to Poliprotect® in Moderate Functional Dyspepsia and Heartburn. (NCT03531372)

Eligibility criteria:
Inclusion Criteria:

          -  Ability to provide informed consent, preferably in writing or, failing that, orally in
             front of a witness, before any study procedure is performed.

          -  Male and female patients aged 18 to 75 years old (inclusive).

          -  Patients with symptoms of functional dyspepsia (according to the Rome IV criteria) of
             moderate severity (VAS score between 30 mm and 70 mm) and/or bothersome heartburn
             within 2 and 14 days prior to the screening/baseline visit.

             o According to the current Rome IV diagnostic criteria, functional dyspepsia is
             defined as one or more of the following symptoms: postprandial fullness (classified as
             postprandial distress syndrome), early satiation (inability to finish a normal sized
             meal, also classified as postprandial distress syndrome), and epigastric pain or
             burning (classified as epigastric pain syndrome).

          -  Ability of the patients (according to the investigator's opinion) to comprehend the
             full nature and purpose of the study including possible risks and side effects.

          -  Patients who agree not to alter their diet in any way for the duration of the trial
             and to maintain it at steady state.

          -  Patients who agree not to make any major lifestyle changes during the trial.

          -  Willingness to comply with all the study procedures and schedule.

          -  Chronic therapies (if not related to the gastroenterological pathologies object of the
             study, according to the opinion of the investigator) are allowed, if the regimen is
             maintained stable during the whole study.

        Exclusion Criteria:

          -  Declines or unable to provide informed consent.

             - Disease or health condition

          -  Patient presenting at least one of the following symptoms or conditions at screening:
             anemia, chronic gastrointestinal bleeding, progressive unintentional weight loss,
             epigastric mass, anorexia, persistent or recurrent vomiting, dysphagia or odynophagia,
             porphyria, hypophosphatemia, and/or cachexia.

          -  Patients presenting with at least of the following gastrointestinal conditions at
             screening: erosive GERD, Barrett's oesophagus or oesophageal stricture, active or
             healing gastroduodenal ulcer (except scars), history of gastric, duodenal or
             esophageal surgery, symptomatic gallstone, and/or other gastrointestinal disease such
             as gastroenteritis, inflammatory bowel disease, celiac disease and/or colorectal
             cancer.

          -  Patients with known malignancy disease, infectious disease or severe heart or
             pulmonary disease.

          -  Patients with known severe liver or kidney disease (AST/SGOT, ALT/SGPT >2 upper limits
             of normal, serum creatinine >1.5 mg/dl).

          -  Patients with mental or metabolic disorders and any other disease that according to
             the physician can compromise the patient´s safety and/or patient´s study compliance.

             - Treatments

          -  Patients receiving any treatment (pharmacological or medical device) for heartburn or
             dyspeptic symptoms within the last 14 days prior to randomization.

          -  Patients receiving any drugs that could affect symptoms or study evaluation such
             antacids, PPIs, H2RAs, prokinetics, and/or gastric mucosal protectants at baseline
             and/or taken within the last 14 days prior to randomization.

          -  Patients receiving any drugs that could affect symptoms or the study as antibiotics,
             NSAIDs, anticholinergics and/or cholinergic agents.

        Note: Patients will be asked to avoid any drugs of the above mentioned since the beginning
        of the study (baseline visit) until the end of the study.

          -  Patients under triple therapy or eradication therapy against Helicobacter pylori.

          -  Patients planned for long-term new therapies with anti-anxiety agents,
             glucocorticosteroids and anti-inflammatory agents during study period.

          -  Known hypersensitive or intolerance to any components of the study medical devices.

          -  Previous intake of any of the study medical devices.

             - Other general conditions

          -  Patients who are unable to understand or are unwilling to sign an informed consent
             form.

          -  Unable or unwilling to complete all required screening and/or follow-up assessments.

          -  Unable to understand and complete self-administered scales/questionnaires planned to
             be used in the study.

          -  Participation in interventional research studies of investigational medicinal or
             device products (ongoing or terminated less than 30 days before screening)

          -  Patients with active alcohol or drug addiction or any other condition that, in the
             investigator's opinion, would interfere with their ability to comply with the study
             requirements.

          -  Patients with any concurrent condition that, in the investigator's opinion, would
             jeopardize the safety of the patient or compliance with the protocol.

          -  Pregnant or nursing (lactating) women;

          -  Women of childbearing potential and sexually active: they must be willing to use at
             least one acceptable effective contraceptive measure (- progestogen-only oral hormonal
             contraception, where inhibition of ovulation is not the primary mode of action , -
             male or female condom with or without spermicide, - cap, diaphragm or sponge with
             spermicide). Pregnancy test will be performed at screening and at the final/premature
             withdrawal visit. The use of contraception in male patients is not required.
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 75 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