Gastric Cancer Clinical Trial
Official title:
Rescue Therapy for Helicobacter Pylori Eradication: A Randomized and Non-inferiority Trail of Berberine Plus Amoxicillin Quadruple Therapy Versus Tetracycline Plus Furazolidone Quadruple Therapy
This study aims at evaluating efficacy and safety of berberine- amoxicillin containing quadruple therapy(berberine, amoxicillin, esomeprazole and bismuth) versus tetracycline-furazolidone quadruple therapy (tetracycline, furazolidone, esomeprazole and bismuth) in H. pylori rescue therapy. It is hypothesized that berberine-amoxicillin containing quadruple therapy is non-inferior to tetracycline-furazolidone quadruple therapy. Patients with confirmed failure of H. pylori eradication will be randomized to one of the treatments described above. At week 6 follow-up visits, a urea breath test，rapid urease test or helicobacter pylori stool antigen test will be performed 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 13 and 17.
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。
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