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

Not Applicable

Recruiting

• Conditions: Gastritis, Indigestion, Helicobacter Pylori Infection, Gastric Cancer, Peptic Ulcer
• Interventions: Drug: Vonoprazan; Drug: Amoxicillin; Drug: Tetracycline 500mg tid; Drug: Minocycline; Drug: Bismuth; Drug: Clarithromycin 500 mg

• Registration Number: NCT07068607
• Lead Sponsor: Yongquan Shi

Brief 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.

Study Timeline

• Study Start: 2025-04-01
• Study First Submitted: 2025-07-07
• Study First Submitted QC: 2025-07-07
• Study First Posted: 2025-07-16
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-12
• Last Update Posted: 2025-08-14
• Primary Completion: 2025-10-01
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
adverse events	14 days of treatment, and 28 days after treatment	Participants with Adverse Events as a Measure of Safety and Tolerability.The common side effects of the study include headache,dizziness,skin rash,other gastrointestinal disorders,pyrexia,cough and back pain

Trial Locations

Locations (1)

Xijing Hosipital of Digestive Disease; 🇨🇳 Xi'an, Shaanxi, China