gastroesophageal reflux disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients with GERD, whose symptom is refractory to conventional therapy including proton-pump inhibitor or vonoprazan and exhibit its FSSG score beyond 7. Participants will be registered six years after the date of approval of this study. Informed consent is obtained from all subjects before enrollment in the study.
Exclusion criteria
Exclusion criteria: Difficulty evaluating their own condition because of dementia or mental disturbance. Heart or respiratory failure, spinal disease or other poor general condition. Pregnant women or women who may be pregnant. Those who are under the control of a randomized study regarding gastroesophageal reflux disease. Those who are deemed inappropriate by their attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The numerical value change of FSSG (Frequency Scale for the Symptoms of GERD) after 12 months' esophageal exercise therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in FSSG 2-4 weeks, 3 months, and 2 years after starting exercise therapy. Changes in acid suppressive medication intake and endoscopic mucosal lesions 2-4 weeks, 3 months, 1 year, and 2 years after starting exercise therapy. For those who gain consent, pH monitoring (24-hour esophageal pH monitoring or 24-hour esophageal impedance/pH monitoring) and manometry findings. | — |
Countries
Japan
Contacts
Nishijin Hospital Department of Internal Medicine