first-line treatment for H. pylori eradication in non-ulcer dyspeptic patients Helicobacter pylori, Vonoprazan, Quadruple therapy.
Conditions
Interventions
vonoprazan 20 mg, bismuth subsalicylate 1024 mg, metronidazole 400 mg 3 times daily and tetracycline 500 mg 4 times daily for 14 days.,Vonoprazan 20 mg, bismuth subsalicylate 1024 mg, metronidazole 40
Experimental Drug,Experimental Drug
14-day VQT,7-day VQT
Sponsors
Center of Excellence in Digestive Diseases, Thammasat University.
Bualuang ASEAN Chair Professorship at Thammasat University and Center of Excellence in Digestive Diseases, Thammasat University.
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Patients aged between 18 and 70 years who underwent upper gastrointestinal (GI) endoscopy due to an indication as per the guidelines of the Gastroenterological Association of Thailand (GAT) and were found to have H. pylori infection with non-ulcer dyspeptic symptoms were enrolled in the study.
Exclusion criteria
Exclusion criteria: (1) history of upper gastrointestinal bleeding; (2) prior allergic reaction to amoxicillin, metronidazole, bismuth subsalicylate, or tetracycline; (3) use of antibiotics within one month prior to enrollment; (4) prior H. pylori eradication therapy; (5) current use of medication with potential drug interactions with the study medication; (6) the presence of severe comorbidities such as end-stage renal disease, advanced cirrhosis, immunocompromised status, AIDS, malignancy, and/or cerebrovascular disease, (7) pregnancy or lactation, (8) history of arrhythmia or QTc prolongation; (9) previous surgical or endoscopic resection of the upper GI tract; (10) contraindications for gastric biopsy, such as coagulopathy or current use of anticoagulants, and (11) unwillingness to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| effectiveness and tolerability of vonoprazan-based quadruple therapy as the first-line treatment for H. pylori eradication in non-ulcer dyspeptic patients. 13C-urea breath test (UBT) at least 4 weeks after completion of the treatment. Eradication rate | — |
Secondary
| Measure | Time frame |
|---|---|
| tolerability of vonoprazan-based quadruple therapy as the first-line treatment for H. pylori eradication in non-ulcer dyspeptic patients during study until 4 weeks after treatment Reported adverse event,Cost effectiveness at the beginning of study incremental cost-effectiveness ratio (ICER) , cost-effectiveness ratio (CER),effectiveness of vonoprazan-based quadruple therapy against Clarithromycin resistant H. pylori, Metronidazole resistant and dual resistant 13C-urea breath test (UBT) at least 4 weeks after completion of the treatment Eradication rate,CYP3A4/5 genetic polymorphism against H. pylori eradication in non-ulcer dyspeptic patients in both groups at the beginning of study CYP3A4/5 genetic polymorphism | — |
Countries
Thailand
Contacts
Public ContactRathakorn Vilaichone
Chulabhorn International College of Medicine (CICM) at Thammasat University
Outcome results
None listed