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

Recruiting now · Phase 4

Conditions studied: Gastritis, Indigestion, Helicobacter Pylori Infection, Gastric Cancer, Peptic Ulcer

In brief

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.

Key facts

Study ID: NCT07068607
Run by: Yongquan Shi
People needed: 400
Starts: 2025-04-01
Expected to finish: 2025-11-01
Last updated by the study team: 2025-08-14

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Aged 18 - 70 years, regardless of gender;
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;
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.

You may not qualify if…

Patients who have been definitely diagnosed with Hp infection and have received antibiotic eradication treatment;
Patients with contraindications to the study drug or who are allergic to the study drug;
Patients with severe organ damage and complications (such as liver cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine diseases;
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);
Pregnant and lactating women;
Patients who have undergone upper gastrointestinal surgery;
Patients with moderate or severe atypical hyperplasia or high - grade intraepithelial neoplasia;
Patients with symptoms of dysphagia;
Patients with evidence of bleeding or iron - deficiency anemia;
Patients with a history of malignant tumors;
Patients with a history of drug or alcohol abuse within the past 1 year;
Patients who are using systemic glucocorticoids, non - steroidal anti - inflammatory drugs, anticoagulants, platelet aggregation inhibitors (except for using aspirin ≤ 100 mg/d);
Patients with mental disorders;
Patients who have participated in other clinical trials within the past 3 months;
Patients who refuse to sign the informed consent form.

Where it is running

Xijing Hosipital of Digestive Disease — Xi'an, Shaanxi, China (enrolling)

Full record on ClinicalTrials.gov

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