NCT07068607

Efficacy Comparison of Vonoprazan Combined With Different Antibiotics in Dual Therapy for Helicobacter Pylori Eradication: A Prospective, Randomized Controlled Clinical Trial

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Yongquan Shi · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the efficacy of vonoprazan combined with different antibiotics in dual therapy for Helicobacter pylori eradication treatment. Newly infected patients were randomly assigned to four groups: amoxicillin dual therapy, tetracycline dual therapy, minocycline dual therapy, and bismuth quadruple therapy. At the follow - up visit in the 6th week, urea breath test, rapid urease test, or Helicobacter pylori fecal antigen test will be conducted to confirm eradication.

Detailed description

The study will include three phases: screening, treatment and follow-up. Screening: this phase will last a maximum of 14 days and subjects eligibility will be evaluated after signing informed consent. One of urea breath test#rapid urease test or helicobacter pylori stool antigen test will be performed in addition to the baseline routine evaluations. Treatment: Subjects are randomly assigned to treatment and will be treated for 14 days. A randomization visit will take place on Day 0 and an end-of-treatment visit will take place between day 14 and 16. Follow-up: includes one visits. Approximately 28 days after the end of treatment. Eradication of H. Pylori will be confirmed by one of urea breath test#rapid urease test or helicobacter pylori stool antigen test.

Conditions

• Gastritis, Indigestion, Helicobacter Pylori Infection, Gastric Cancer, Peptic Ulcer

Interventions

Type	Name	Description
DRUG	Vonoprazan	Vonoprazan - amoxicillin dual therapy: Vonorazon 20 mg daily for 14 days # amoxicillin 1000 mg by mouth three time daily for 14 days; Vonoprazan-tetracycline dual therapy:Vonorazon 20 mg daily for 14 days # tetracycline 500 mg by mouth three time daily for 14 days; Vonoprazan-minocycline dual therapy:Vonorazon 20 mg daily for 14 days # minocycline 100 mg by mouth two time daily for 14 days; Bismuth-containing quadruple therapy:Amoxicillin 1000 mg, clarithromycin 500 mg, vonoprazan 20 mg, and colloidal bismuth tartrate 220 mg, all twice a day for 14 days
DRUG	Tetracycline 500mg tid	Vonoprazan-tetracycline dual therapy:Vonorazon 20 mg daily for 14 days # tetracycline 500 mg by mouth three time daily for 14 days
DRUG	Minocycline	Vonoprazan-minocycline dual therapy Vonorazon 20 mg daily for 14 days # minocycline 100 mg by mouth two time daily for 14 days
DRUG	Bismuth	Bismuth-containing quadruple therapy:Amoxicillin 1000 mg, clarithromycin 500 mg, vonoprazan 20 mg, and colloidal bismuth tartrate 220 mg, all twice a day for 14 days
DRUG	Clarithromycin 500 mg	Bismuth-containing quadruple therapy:Amoxicillin 1000 mg, clarithromycin 500 mg, vonoprazan 20 mg, and colloidal bismuth tartrate 220 mg, all twice a day for 14 days
DRUG	Amoxicillin	Vonoprazan - amoxicillin dual therapy:Vonorazon 20 mg daily for 14 days # amoxicillin 1000 mg by mouth three time daily for 14 days; Bismuth-containing quadruple therapy:Amoxicillin 1000 mg, clarithromycin 500 mg, vonoprazan 20 mg, and colloidal bismuth tartrate 220 mg, all twice a day for 14 days

Timeline

• Start date: 2025-04-01
• Primary completion: 2025-10-01
• Completion: 2025-11-01
• First posted: 2025-07-16
• Last updated: 2025-08-14

Locations

1 site across 1 country: China