Clinical trial: The Effect of Autonomic Modulation on Symptoms in Patients With Reflux Hypersensitivity (NCT04253444)

Eligibility criteria:
Inclusion Criteria:

          -  Male and female patients over the age of 18 years.

          -  Women in the follicular phase of the menstrual cycle (visits will be arranged so that
             in menstruating women, the study will be started in the follicular phase of the
             menstrual cycle to standardise for possible confounding effects of the menstrual cycle
             on symptom perception).

          -  Able to give informed consent

          -  Able to speak and understand English without the need for an interpreter

          -  No evidence of erosive esophagitis by OGD

          -  Presence of chest pain, heartburn, and/or regurgitation ≥ 3 days/week

          -  Normal acid exposure on MII-pH

          -  Positive symptom reflux association on MII-pH (symptom index ≥ 50% and symptom
             association probability ≥ 95%)

          -  OGD is performed within 2 years before the enrolment

          -  MII-pH study is performed within 2 year before the enrolment

        Exclusion Criteria:

          -  Current or previous GI or medical illnesses that may affect ANS / GI function

          -  Current or previous significant CNS illness

          -  Current medications affecting the CNS, GI or ANS systems

          -  Pregnancy and lactation

          -  Cardiac dysrhythmias

          -  Those who do not have access to the internet-based questionnaire

               -  The use of acid suppression therapies (e.g. proton pump inhibitor or H2 blocker)
                  or pain modulators (e.g. low-dose Tricyclic Antidepressants, TCAs or Selective
                  Serotonin Reuptake Inhibitors, SSRI) does not change the decision of
                  participation as long as above-mentioned symptoms remain.

        Patients are asked to refrain from smoking for 12 hours and drinking alcohol as well as
        using recreational drugs for 48 hours prior to study visit.
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? Contradiction