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

NCT07068607 · tracked via the Priya Life Science China tracker

Sponsor

Yongquan Shi

Phase

Phase 4

Started

2025-04-01

Last updated

2025-08-14

Condition(s) studied

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

Investigational drug(s) / intervention(s)

Vonoprazan →Tetracycline 500mg tid →Minocycline →Bismuth →Clarithromycin 500 mg →Amoxicillin →

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

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

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

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

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

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

Study 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

Sex

ALL

Min age

18 Years

Max age

70 Years

Healthy volunteers

Inclusion Criteria: 1. Aged 18 - 70 years, regardless of gender; 2. Patients with definite Hp infection (positive result in any one of the 13C/14C urea breath test, rapid urease test, and fecal Hp antigen test) who have never received Helicobacter pylori eradication treatment; 3. For women of child - bearing age, it is required to use medically acceptable contraceptive methods during the trial period and within 30 days after the end of the trial. Exclusion Criteria: 1. Patients who have been definitely diagnosed with Hp infection and have received antibiotic eradication treatment; 2. Patients with contraindications to the study drug or who are allergic to the study drug; 3. Patients with severe organ damage and complications (such as liver cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine diseases; 4. Patients who have been continuously using anti - ulcer drugs (including taking PPI within 2 weeks before the Hp infection test), antibiotics or bismuth complexes (more than 3 times a week within 1 month before screening); 5. Pregnant and lactating women; 6. Patients who have undergone upper gastrointestinal surgery; 7. Patients with moderate or severe atypical hyperplasia or high - grade intraepithelial neoplasia; 8. Patients with symptoms of dysphagia; 9. Patients with evidence of bleeding or iron - deficiency anemia; 10. Patients with a history of malignant tumors; 11. Patients with a history of drug or alcohol abuse within the past 1 year; 12. Patients who are using systemic glucocorticoids, non - steroidal anti - inflammatory drugs, anticoagulants, platelet aggregation inhibitors (except for using aspirin ≤ 100 mg/d); 13. Patients with mental disorders; 14. Patients who have participated in other clinical trials within the past 3 months; 15. Patients who refuse to sign the informed consent form.

Primary outcome measure(s)

Helicobacter pylori eradication — 28 days after treatment
The primary end point of this study is H.pylori eradication#established by negative \[13C\] urea breath test #DOB value below 3.9#28 days after the end of eradication

Trial sites (1)

Facility	City	Region	Status
Xijing Hosipital of Digestive Disease	Xi'an	Shaanxi	Recruiting

On this site

📄 Amoxil (amoxicillin) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07068607 on ClinicalTrials.gov ↗ ← All trials in China