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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.
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.
Age
18 - 70 years
Sex
ALL
Healthy Volunteers
No
Xijing Hosipital of Digestive Disease
Xi'an, Shaanxi, China
Start Date
April 1, 2025
Primary Completion Date
October 1, 2025
Completion Date
November 1, 2025
Last Updated
August 14, 2025
400
ESTIMATED participants
Vonoprazan
DRUG
Tetracycline 500mg tid
DRUG
Minocycline
DRUG
Bismuth
DRUG
Clarithromycin 500 mg
DRUG
Amoxicillin
DRUG
Lead Sponsor
Yongquan Shi
Data Source & Attribution
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