RecruitingPhase 4NCT07068607

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

Sponsor

Yongquan Shi

Enrollment

400 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing different antibiotic combinations paired with a new acid-suppressing drug (vonoprazan) to find out which works best at eliminating H. pylori — a stomach bacteria that causes ulcers and increases cancer risk — in patients who have never been treated for it before. **You may be eligible if...** - You are 18 to 70 years old - You have tested positive for H. pylori (via breath test, rapid urease test, or stool antigen test) - You have NEVER been treated for H. pylori with antibiotics before **You may NOT be eligible if...** - You have previously received antibiotic treatment for H. pylori - You are allergic to any of the study drugs - You have severe liver, kidney, or heart disease - You have had upper gastrointestinal surgery - You have a history of stomach cancer or precancerous stomach lesions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVonoprazan

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

DRUGTetracycline 500mg tid

Vonoprazan-tetracycline dual therapy:Vonorazon 20 mg daily for 14 days # tetracycline 500 mg by mouth three time daily for 14 days

DRUGMinocycline

Vonoprazan-minocycline dual therapy Vonorazon 20 mg daily for 14 days # minocycline 100 mg by mouth two time daily for 14 days

DRUGBismuth

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

DRUGClarithromycin 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

DRUGAmoxicillin

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

Locations(1)

Xijing Hosipital of Digestive Disease

Xi'an, Shaanxi, China

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NCT07068607