Helicobacter Pylori and Vonoprazan Dual Therapy

• Status: Not yet recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Our previous study included 119 Helicobacter pylori(H. pylori)-infected Chinese patients without previous eradication history who were randomized to low-or high-dose amoxicillin-vonoprazan regimens consisting of amoxicillin 1 gram either b.i.d. or t.i.d plus vonoprazan 20 mg b.i.d for 7 or 10 days. Neither 7-or 10-day VA dual therapy with either b.i.d. or t.i.d. amoxicillin achieved satisfied efficacy (i.e., <90%) when given as first-line treatment for H. pylori infection. This study evaluated the efficacy and safety of low-and high-dose amoxicillin-vonoprazan dual therapy for 14 days as first-line treatment for H. pylori in China.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The First Affiliated Hospital of Nanchang University

Criteria

Inclusion Criteria:

• Consecutive H. pylori-infected subjects ages from 18 to 70 without eradication history

Exclusion Criteria:

• allergy to amoxicillin or vonoprazan;

• acute upper gastrointestinal bleeding, gastric cancer or other tumors, Zollinger-Ellison syndrome, history of gastric surgery;

• serious illness including neurological, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, endocrinological or hematological disorders;

• pregnancy or breast feeding;

• proton pump inhibitors and antibiotics use within one month;

• not willing to participate in the study