Actively Recruiting
Efficacy Comparison of Vonoprazan Combined With Different Antibiotics in Dual Therapy for Helicobacter Pylori Eradication: A Prospective, Randomized Controlled Clinical Trial
Led by Yongquan Shi · Updated on 2025-08-14
400
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy Comparison of Vonoprazan Combined With Different Antibiotics in Dual Therapy for Helicobacter Pylori Eradication: A Prospective, Randomized Controlled Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 70 years, any gender
- Confirmed Helicobacter pylori infection by positive result in urea breath test, rapid urease test, or fecal antigen test
- No previous Helicobacter pylori eradication treatment
- Women of childbearing age must use accepted contraceptive methods during the trial and for 30 days after completion
You will not qualify if you...
- Previous Helicobacter pylori treatment with antibiotics
- Allergic or contraindicated to study drugs
- Severe organ damage or complications such as liver cirrhosis or uremia
- Severe or unstable heart, lung, or endocrine diseases
- Regular use of anti-ulcer drugs, antibiotics, or bismuth compounds recently
- Pregnant or breastfeeding women
- History of upper gastrointestinal surgery
- Moderate to severe atypical hyperplasia or high-grade intraepithelial neoplasia
- Symptoms of difficulty swallowing
- Evidence of bleeding or iron-deficiency anemia
- History of cancer
- Drug or alcohol abuse in the past year
- Use of systemic glucocorticoids, NSAIDs, anticoagulants, or platelet inhibitors (except low-dose aspirin)
- Mental disorders
- Participation in other clinical trials within 3 months
- Refusal to sign informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
Xijing Hosipital of Digestive Disease
Xi'an, Shaanxi, China, 710032
Actively Recruiting
Research Team
Y
Yongquan Shi, Ph. D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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