Helicobacter Pylori and Lacidophilin Tablets in Combination With Vonorazan Dual Therapy

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• 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. Lacidophilin tablets have been reported to increase the eradication rate of H. pylori while reducing the incidence of adverse effects.This study evaluated the efficacy and safety of lacidophilin tablets in combination with amoxicillin-vonoprazan dual therapy for 10 days as first-line treatment for H. pylori in China.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

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,vonoprazan or lacidophilin tablets;

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

• gastroscopy report showing or past medical history of significant esophagogastric disease, including gastric cancer, peptic ulcer, esophagitis, esophageal erosion.

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

• pregnancy or breast feeding;

• proton pump inhibitors, antibiotics and probiotics use within one month;

• not willing to participate in the study.