gastroesophageal reflux disease
Conditions
Interventions
28day treatment with vonoprazan 20mg
Sponsors
Nippon Medical School, Graduate School of Medicine.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18 <= age <= 75 2. heartburn as a chief complaint 3. total score is 8 or more on the Frequency Scale for the Symptoms of GERD (FSSG)
Exclusion criteria
Exclusion criteria: 1. Take medication that can influence the secretion of saliva, such as antiadrenergic agents and adrenergic alpha-2 agonists, antidepressants, psychotropic drugs, anticholinergic drugs, and smokers in the last two weeks before enrollment. 2. Take medication that affects the secretion of gastric acid, such as PPI, PCAB, and histamine H2 receptor antagonists in the last two weeks before enrollment. 3. Have scleroderma and Sjogren syndrome that can affect esophageal motility and saliva secretion. 4. Have current peptic ulcers. 5. Have an upper gastrointestinal surgery 6. Have severe complications such as heart disease or cancer. 7. Have an allergy to xylocaine. 8. Have an allergy to vonoprazan. 9. pregnant or lactating 10. Have an oral environment in which gum chewing is likely to cause dental problems, such as caries or unstable teeth
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in salivary secretion after PCAB administration in PCAB-responsive patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| We will investigate the flollowings: 1) change in salivary secretion after PCAB administration in PCAB-refractory patients. 2) correlation between saliva volume and PSPW index 3) correlation between saliva volume and other parameters of reflux monitoring test 4) Whether saliva volume is a predictor of PCAB efficacy. Logistic regression multivariate analysis will be performed using age, gender, and BMI as covariates. If other significant factors are found in the univariate analysis, the covariates will be changed or added. 5) changes in salivary pH and buffering capacity (pH change after acid loading) after PCAB administration. 6) correlation between changes in salivary volume and anxiety/depression, hypervigilance, and sleep scores 7) comparison of changes in salivary pH and buffering capacity between the PCAB responsive and refractory groups. 8) correlation between the symptomatic improvement effect of PCAB and objective GERD diagnosis by endoscopy and reflux monitoring tests. 10) correlation between the degree of mucosal damage at the esophagogastric junction under endoscopy and the objective diagnosis of GERD by reflux monitoring. correlation between the degree of mucosal damage and severity of reflux symptoms. | — |
Countries
Japan
Contacts
Public ContactYoshimasa Hoshikawa
Nippon Medical School, Graduate School of Medicine. Department of Gastroenterology
Outcome results
None listed